View and download the Consolidated Document: Consolidated Document 01/VBHN-BYT March 16, 2020
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DECREE
ON MEDICAL EQUIPMENT MANAGEMENT
Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on medical equipment management, effective from July 1, 2016, is amended and supplemented by:
1. Decree No. 169/2018/ND-CP dated December 31, 2018 of the Government amending and supplementing a number of articles of Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on medical equipment management, effective from December 31, 2018.
2. Decree No. 03/2020/ND-CP dated January 1, 2020 of the Government amending and supplementing Article 68 of Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on medical equipment management, as amended and supplemented by Decree No. 169/20181ND-CP dated December 31, 2018, effective from January 1, 2020.
Pursuant to the Law on Organization of the Government dated June 19, 2015; Pursuant to the Law on Investment dated November 26, 2014;
Considering the proposal of the Minister of Health;
The Government issued a Decree on medical equipment management.1
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation
This Decree regulates the management of medical equipment, including: classification of medical equipment; production, circulation, purchase and sale, provision of medical equipment services; information, labeling of medical equipment, and management and use of medical equipment at medical facilities.
Article 2. Interpretation of terms
1.2 Medical equipment is equipment, tools, materials, implants, reagents and in vitro calibrators, software that simultaneously meets the following requirements:
a) Used individually or in combination as directed by the owner of the medical device to serve humans for one or more of the following purposes:
– Diagnose, prevent, monitor, treat and alleviate disease or compensate for injury or trauma;
– Examine, replace, adjust or support anatomy and physiological processes;
– Support or sustain life;
– Control conception;
– Disinfecting medical equipment, including chemicals used in testing procedures;
– Providing information for diagnosis, monitoring and treatment through testing of specimens derived from the human body.
b) Not using pharmacological, immunological or metabolic mechanisms in or on the human body or if using these mechanisms, they are only for supporting purposes to achieve the purpose specified in Point a of this Clause.
2. In vitro diagnostic medical device includes reagents, calibrators, control materials, instruments, machines, equipment or systems used separately or in combination as directed by the owner to serve the examination of specimens originating from the human body.
3. An accessory is a product intended by the medical device owner to be used for a specific purpose in conjunction with a specific medical device to facilitate or assist the use of that device for its intended purpose.
4. The owner of medical equipment is an organization or individual that:
a) Supply medical equipment under its own name or under any trademark, design, trade name or other name or code owned or controlled by that individual or organization;
b) Responsible for the design, manufacture, assembly, processing, labeling, packaging or repair of medical equipment or determining the intended use of such medical equipment.
Article 3. Principles of medical equipment management
1. Ensure quality, safety and effective use of medical equipment.
2. Full, accurate and timely information on technical specifications, uses of medical equipment and possible risks to users.
3. Ensure traceability of medical equipment.
4. Management of medical equipment must be based on classification of risk levels and national standards, national technical regulations issued and recognized by competent state management agencies or announced and applied by organizations and individuals in accordance with the provisions of law.
5. Medical equipment that is a measuring instrument and radiation equipment must be managed according to the provisions of the law on measurement, the law on atomic energy and the provisions of this Decree.
Chemicals and preparations with the sole purpose of disinfecting medical equipment are managed according to the provisions of this Decree. Chemicals and preparations with the purpose of disinfecting medical equipment but also have other uses are managed according to the provisions of the law on chemicals and insecticides and disinfectants used in the household and medical fields.
6.3 Trading in medical equipment and raw materials for manufacturing medical equipment containing narcotic substances and precursors must, in addition to complying with the provisions of this Decree, also comply with the provisions of the law on drug prevention and control.
Chapter II
CLASSIFICATION OF MEDICAL EQUIPMENT4
Article 4. Types and principles of classification of medical equipment
1. Medical devices are divided into 2 groups which are divided into 4 types based on the level of potential risks associated with the technical design and manufacture of such medical devices:
a) Group 1 includes medical equipment of type A, which is medical equipment with a low risk level.
b) Group 2 includes medical equipment of types B, C, D, including:
– Type B medical equipment is medical equipment with a low-medium risk level;
– Type C medical equipment is medical equipment with a medium-high risk level;
– Type D medical equipment is medical equipment with a high level of risk.
2. Principles of medical equipment classification:
a) The classification of medical equipment must be based on the classification rules on risk levels and must be performed by an establishment that has declared its eligibility to classify medical equipment according to the provisions of this Decree;
b) Medical devices that have only one intended use but that intended use can be classified into two or more different risk levels shall be classified according to the highest risk level;
c) Medical equipment has multiple uses and each use has a different level of risk, then the classification according to the highest level of risk shall be applied;
d) For medical devices designed to be used in combination with another medical device, each medical device may be classified by its own risk level, but the classification must be based on the highest risk level of the intended end use of the combined medical device as a whole.
3. The Minister of Health shall specify in detail the classification of medical equipment to ensure compliance with international treaties on classification of medical equipment of the Association of Southeast Asian Nations of which Vietnam is a member.
Article 5. Basis for classifying medical equipment
1. Classification of medical equipment must be performed by qualified facilities as prescribed in Article 7 of this Decree.
2. The classification facility must base on the definition specified in Article 2 of this Decree, the principles specified in Article 4 of this Decree, the documents specified in Points e, g, h, i, Clause 1, Article 26 of this Decree and the classification rules issued by the Ministry of Health to classify medical equipment.
3. The facility that classifies medical equipment must be legally responsible for the classification results of the medical equipment it has classified.
4. In case there is a difference in the results of medical equipment classification between classification facilities, the Ministry of Health shall decide on the classification of medical equipment.
Article 6. Conditions, documents, procedures for granting and adjusting certificates of practice in medical equipment classification
1. Conditions for applicants for a certificate of practice in medical equipment classification (hereinafter referred to as a certificate of practice):
a) Have a university degree in engineering, medicine or pharmacy or higher;
b) Have worked directly in the field of medical equipment for at least 24 months within 48 months from the date of application submission;
c) Completed a training course on medical equipment classification according to the training program of the Ministry of Health at medical facilities that have been granted a continuous training code.
2. Documents and procedures for requesting a new practice certificate:
a) Application for new practice certificate:
– Application for new practice certificate according to Form No. 17 specified in Appendix I issued with this Decree;
– Original or certified copy of university degree in engineering, medicine, pharmacy or higher. In case the degree is issued by a foreign country, it must be recognized as equivalent by the Ministry of Education and Training;
– Original or certified copy of the valid Certificate of training in medical equipment classification (03 years from the date of signing);
– Two 4 cm x 6 cm color photos taken on a white background within 06 months from the date of application submission;
– Original or certified copy of the Identity Card or Citizen Identification Card or Passport of the certificate applicant;
– Original or copy of the Confirmation of working time according to the form prescribed in Appendix III issued with this Decree. In case the person performing the classification of medical equipment works at many different facilities and the working time at one facility is less than 24 months, he/she must provide a Confirmation of each facility to prove sufficient working time as prescribed in Point b, Clause 1 of this Article.
b) Procedures for issuing new practice certificates:
– Within 20 days from the date of full submission, the Ministry of Health must conduct appraisal of the dossier;
– In case of valid dossier: within 10 working days from the date of appraisal, the Ministry of Health shall issue a practice certificate according to Form No. 10 specified in Appendix IV issued with this Decree and publicly disclose the following information on the electronic information portal: practice certificate of the person performing the classification and the dossier for granting practice certificate of the person performing the classification.
– In case of invalid documents:
Within 05 working days from the date of completion of the assessment, the Ministry of Health must issue a written notice to the applicant for a practice certificate to complete the application. The written notice must specify the documents that need to be supplemented and the content that needs to be revised;
Upon receiving a written request to complete the application, the applicant for a practice certificate must amend and supplement it in accordance with the contents stated in the document and send the supplementary application to the Ministry of Health. After receiving the supplementary application, the Ministry of Health shall continue to evaluate the application in accordance with the provisions of this clause;
In case the supplementary documents are valid: The Ministry of Health shall issue a practice certificate according to the provisions of this clause;
In case the supplementary documents are still invalid: The Ministry of Health requests the applicant for a practice certificate to continue completing the documents.
Within 60 days from the date the Ministry of Health issues a written notice of amendments or supplements, the applicant for a practice certificate must submit an amended or supplemented application as required. After the above deadline, if the applicant fails to amend or supplement, or if, after 03 months from the date of initial submission of the application, the supplemented application does not meet the requirements, the submitted application is no longer valid.
3. Documents and procedures for adjusting the content of medical equipment classification practice certificate:
a) Application for adjustment of practice certificate content:
– Document requesting to adjust information in the practice certificate according to Form No. 18 specified in Appendix I issued with this Decree;
– Original or copy of documents proving the change in case of change of administrative information: name, identity card number or citizen identification card or passport of the person performing the classification;
– Original or certified copy of Certificate of training in medical equipment classification in case of change of scope of practice or update of Certificate of training in medical equipment classification;
– Original or copy of the Confirmation of working time according to the form prescribed in Appendix III issued with this Decree. In case the person performing the classification of medical equipment works at many different facilities and the working time at one facility is less than 24 months, he/she must provide a confirmation from each facility to prove the sufficient working time as prescribed in Point b, Clause 1 of this Article.
b) Adjustment procedure:
– Within 10 days from the date of receiving the application for adjustment, the Ministry of Health must appraise the application;
– In case of valid dossier: The Ministry of Health will issue a practice certificate according to Form No. 11 specified in Appendix IV issued with this Decree and update the changed information on the Ministry of Health's electronic information portal within 03 working days.
– In case of invalid documents:
Within 05 working days from the date of the appraisal report, the Ministry of Health must send a written notice to the applicant to complete the dossier. The written notice must specify the documents that need to be supplemented and the content that needs to be revised.
Upon receiving a written request for completion of the dossier, the person requesting the adjustment must amend and supplement it in accordance with the contents stated in the document and send the supplementary dossier to the Ministry of Health. After receiving the supplementary dossier, the Ministry of Health shall continue to appraise the dossier in accordance with the provisions of this clause.
In case the application is valid, within 03 working days from the date of the appraisal record, the Ministry of Health will make adjustments to the practice certificate.
In case the supplementary documents are still invalid: The Ministry of Health requests the person requesting the adjustment to continue completing the documents.
Within 60 days from the date the Ministry of Health issues a written notice of amendments or supplements, the applicant must submit the amended or supplemented documents as required. After the above deadline, if the applicant fails to amend or supplement, or after 03 months from the date of initial submission of the application, the supplemented documents do not meet the requirements, the submitted documents will no longer be valid.
Article 7. Conditions, documents and procedures for declaring eligibility to classify medical equipment
1. Conditions of the facility performing medical equipment classification (hereinafter referred to as the classification facility): Have at least 01 person with a certificate of practice in medical equipment classification.
2. The dossier for declaring eligibility to classify medical equipment includes:
a) Document announcing eligibility to classify medical equipment according to Form No. 01 specified in Appendix I issued with this Decree;
b) Personnel declaration according to the form prescribed in Appendix II issued with this Decree, accompanied by the original or certified copy of the practice certificate of each person performing the classification of medical equipment named in the personnel declaration;
c) Original or certified copy of the establishment's Business Registration Certificate or Investment Certificate.
3. Procedures for declaring eligibility to classify medical equipment:
a) Before classifying medical equipment, the facility shall submit a dossier declaring eligibility to classify medical equipment as prescribed in Clause 2 of this Article to the Ministry of Health;
b) Upon receiving a complete and valid dossier, the Ministry of Health shall issue to the facility a Receipt of dossier for declaration of eligibility to classify medical equipment according to Form No. 01 specified in Appendix IV attached to this Decree;
c) Within 03 working days from the date recorded on the Receipt of dossier for declaration of eligibility for classification of medical equipment, the Ministry of Health shall be responsible for publicizing on the Ministry of Health's electronic information portal the following information: name, address, phone number and scope of the classification facility and dossier for declaration of eligibility for classification of medical equipment.
4. Adjust information in the declaration dossier for eligibility to classify medical equipment:
a) Cases where information in the declaration dossier for eligibility to classify medical equipment is adjusted:
– Change the person performing the medical equipment classification in case the replacement person has the same scope of practice as the replaced person;
– Change administrative information: address, phone number of the classification facility; information about the legal representative of the classification facility.
b) Application for adjusting information in the declaration of eligibility to classify medical equipment:
– A written request for adjustment according to Form No. 19 specified in Appendix I issued with this Decree, which must clearly state the content of the change (including the case of notifying the person performing the classification to no longer continue working at the facility performing the classification);
– In case of change of classifier: Original or certified copy of practice certificate of the replacement person with the same scope of practice as the replaced person;
– In case of change of administrative information: Documents proving change of address, phone number of the classification facility; information about the legal representative of the classification facility.
c) Adjustment procedure:
– After receiving the application for adjustment of information in the dossier declaring eligibility to classify medical equipment, the Ministry of Health shall issue to the facility a Receipt of adjustment of dossier declaring eligibility to classify medical equipment according to Form No. 13 specified in Appendix IV issued with this Decree;
– Within 03 working days from the date recorded on the Receipt of Adjustment of the Declaration of Eligibility for Classification, the Ministry of Health is responsible for updating the changed information on the Ministry of Health's electronic information portal. In case of non-acceptance, a written response must be provided stating the reasons.
5. Classification facilities may only classify medical equipment after receiving a Receipt of dossier declaring eligibility to classify medical equipment from the Ministry of Health.
6. During operation, the classification facility must re-conduct the procedure for declaring eligibility to classify medical equipment if there is a change in the classifier whose scope of practice is not included in the previous classification eligibility declaration file.
Article 8. Temporary suspension of classification activities
1. Cases of temporary suspension:
a) Classifying medical equipment without declaring sufficient conditions to classify medical equipment;
b) Using documents that do not guarantee honesty and accuracy to declare eligibility for medical equipment classification;
c) Not meeting the conditions prescribed in Article 7 of this Decree;
d) Issuing incorrect classification results that reduce the risk level of medical devices;
d) Issuing classification results signed by a person whose name is not on the Receipt of the dossier for declaration of eligibility for classification or who is not the legal representative;
e) Failure to remedy the consequences or remedying the consequences but not meeting the requirements of the management agency;
g) Failure to publicly disclose the issued classification results as prescribed in Point c, Clause 5, Article 66 and Clause 8, Article 68 of this Decree.
2. Temporary suspension procedure:
a) During the inspection process, if the classification facility or the person performing the classification is found or suspected of violating the provisions of Clause 1 of this Article, the inspection agency shall be responsible for drawing up a working record according to the form prescribed in Appendix XII issued with this Decree and recommending the competent authority to request the classification facility or the person performing the classification to temporarily suspend the medical equipment classification activities, and at the same time send the record to the Ministry of Health within 24 hours from the time of completion of the record;
b) Within 24 hours of receiving the minutes, the Ministry of Health shall be responsible for notifying the Department of Health, the General Department of Customs and the Customs at border gates to temporarily suspend the processing of dossiers related to medical equipment using the classification results recorded in the working minutes until there is an official conclusion from the Ministry of Health. At the same time, the Ministry of Health shall send a document requesting the classification facility to explain the contents recorded in the working minutes;
c) Within 03 working days from the date of receiving the explanatory report of the classification facility, the Ministry of Health shall be responsible for evaluating the contents of the explanatory report of the classification facility;
d) In case the explanation of the classification facility is accepted and there is no request to take remedial measures, the Ministry of Health shall be responsible for issuing a document notifying the termination of the temporary suspension of classification activities. The document terminating the temporary suspension of classification activities shall be sent to the classification facility, the Department of Health, the General Department of Customs and the Customs at border gates and shall be publicly posted on the Electronic Information Portal of the Ministry of Health;
d) In case the explanation of the classification facility is accepted and remedial measures are required, the Ministry of Health shall be responsible for issuing a written notice to the classification facility to carry out remedial measures. This document shall be sent to the classification facility, the Department of Health, the General Department of Customs and the Customs at border gates and shall be publicly posted on the Ministry of Health's electronic information portal;
Classification facilities whose classification activities are temporarily suspended must report in writing to the Ministry of Health after completing the remedial work.
Within 03 working days from the date of receipt of the remedial report of the classification facility whose classification activities have been temporarily suspended, the Ministry of Health shall issue a document terminating the temporary suspension or requesting continued remedial measures or carrying out the revocation procedures prescribed in Article 9 of this Decree. This document shall be sent to the classification facility, the Department of Health, the General Department of Customs and the Customs at border gates and shall be publicly posted on the Ministry of Health's electronic information portal.
e) In case the explanation of the classification facility is not accepted, the Ministry of Health shall be responsible for issuing a document requesting the agencies receiving the dossiers declaring eligibility for classification to carry out the recall procedures prescribed in Article 9 and handle the medical equipment using the recalled classification results prescribed in Article 10 of this Decree.
Article 9. Withdrawal of Receipt of dossier for declaration of eligibility for medical equipment classification, certificate of practice for medical equipment classification and results of medical equipment classification
1. Withdrawal of Receipt of dossier for declaration of eligibility to classify medical equipment:
a) Cases of recall:
– Forging documents in the dossier declaring eligibility to perform medical equipment classification;
– Not meeting the conditions prescribed in Clause 1, Article 7 of this Decree;
– Issuing classification results while operations are temporarily suspended;
– Issue the results of the second classification of medical equipment to reduce the risk level of medical equipment within 12 months;
– Failure to remedy the consequences or remedying the consequences but not meeting the requirements of the management agency.
b) Withdrawal procedure:
– Within 01 working day from the date of conclusion that the classification facility has committed a violation in one of the cases specified in Point a of this Clause, the Ministry of Health shall be responsible for issuing a document to revoke the Receipt of dossier declaration of eligibility for medical equipment classification, in which remedial measures (if any) must be clearly stated and at the same time cancel the information of the classification facility whose Receipt of dossier declaration of eligibility for medical equipment classification has been revoked on the Ministry of Health's electronic information portal.
The document withdrawing the Receipt of dossier for declaration of eligibility for classification of medical equipment is sent to the classification facility, the Department of Health, the General Department of Customs and Customs at border gates and is publicly posted on the Electronic Information Portal of the Ministry of Health;
– After receiving the document withdrawing the Receipt of dossier for declaration of eligibility for medical equipment classification from the Ministry of Health, the classification facility is responsible for immediately stopping the medical equipment classification activities and taking remedial measures (if any), and must be responsible for resolving the consequences caused by its illegal acts;
– In case the classification facility does not comply or does not fully comply with the contents of the document withdrawing the Receipt of dossier for declaration of eligibility to classify medical equipment, the Ministry of Health is responsible for transferring the dossier to other competent authorities for further handling in accordance with the provisions of law.
2. Revocation of medical equipment classification practice certificate:
a) Cases of recall:
– Forging documents in the application for a certificate of practice in classifying medical equipment;
– Classify medical equipment when it does not meet the conditions prescribed in this Decree;
– Carry out the classification and issue the results of medical equipment classification when the certificate of training in medical equipment classification has expired;
– Misclassification reduces the risk level of a medical device for the second time within 12 months;
– Carry out classification and issue classification results while the operation is temporarily suspended, including the case where the facility performing the classification where the person is working is temporarily suspended or the Receipt of dossier for declaration of eligibility to perform classification is revoked.
b) Procedures for revoking practice certificates:
– Within 01 working day from the date of conclusion that the person performing the classification has committed a violation in one of the cases specified in Point a of this Clause, the Ministry of Health shall be responsible for issuing a document revoking the practice certificate, in which it must request the classification facility where the person performing the classification is working to take remedial measures for the consequences caused by the violation of the person performing the classification (if any) and at the same time cancel the information of the person performing the classification of medical equipment whose practice certificate has been revoked on the Ministry of Health's electronic information portal.
The document revoking the practice certificate is sent to the person performing the classification, the classification facility where that person is working, the Department of Health, the General Department of Customs and Customs at border gates and is publicly posted on the Ministry of Health's electronic information portal;
– After receiving the document revoking the practice certificate, the person performing the classification and the classification facility where that person is working are responsible for immediately stopping the medical equipment classification activities and taking remedial measures (if any), and at the same time must be responsible for resolving the consequences caused by their illegal acts;
– In case the person performing the classification and the classification facility where that person is working do not comply or do not fully comply with the contents of the document revoking the practice certificate, the Ministry of Health shall carry out the procedure to revoke the Receipt of the dossier for declaration of eligibility for classification and transfer the dossier to other competent authorities for further handling in accordance with the provisions of law.
3. Recall classification results:
a) Cases of recall:
– Misclassification results in a reduction in the risk level of the medical device;
– The classification result is signed by a person whose name is not on the Receipt of the dossier for declaration of eligibility for classification or is not the legal representative of the classification facility;
– The classification results were falsified;
– Classification results are issued when the classification facility is temporarily suspended or when the Receipt of Application for Classification Eligibility Declaration has been revoked.
b) Withdrawal procedure:
– Within 01 working day from the date of conclusion that the classification result falls into one of the cases specified in Point a of this Clause, the Ministry of Health shall be responsible for issuing a document to revoke the classification result, in which it must request the classification facility to take remedial measures for the consequences caused by the violation (if any) and at the same time cancel information on the classification result of the medical equipment that has been revoked on the Ministry of Health's Electronic Information Portal;
The document withdrawing the classification results is sent to the medical equipment classification facility, the Department of Health, the General Department of Customs and Customs at border gates and is publicly posted on the Ministry of Health's electronic information portal.
– After receiving the document withdrawing the classification results, the classification facility is responsible for withdrawing all classification results recorded in the withdrawal document, and is also responsible for resolving the consequences caused by its illegal acts;
In case the classification facility does not comply or does not fully comply with the contents of the document revoking the classification results, the Ministry of Health shall carry out the procedure to revoke the Receipt of dossier declaring eligibility to perform classification and transfer the dossier to other competent authorities for further handling in accordance with the provisions of law.
– After receiving the document withdrawing the classification results, the agency that receives the dossier announcing the applicable standards or requesting the issuance of a circulation number (hereinafter referred to as the dossier issuing the circulation number) is responsible for reviewing the circulation numbers it has issued. In case it is discovered that a medical device that has been issued a circulation number uses a classification result that has been revoked by the Ministry of Health, the agency that issued the circulation number is responsible for carrying out the procedure to withdraw the circulation number for that medical device.
Article 10. Handling of medical equipment using recalled classification results
1. In case the medical equipment is undergoing the procedure to request a circulation number and uses a classification result that has been issued a recall document by the Ministry of Health:
a) Organizations and individuals submitting applications for publication of applicable standards or applications for issuance of circulation numbers are responsible for reporting in writing to the agency receiving applications for issuance of circulation numbers to stop the procedures for issuance of circulation numbers;
b) After receiving a request document from an organization or individual specified in Point a of this Clause or after receiving a document withdrawing the medical equipment classification, the dossier receiving agency is responsible for refusing to issue a circulation number.
2. In case the medical equipment has been granted a circulation number but uses a classification result that has been issued a recall document by the Ministry of Health but has not yet completed customs clearance procedures:
a) The owner of the circulation number is responsible for stopping the customs clearance procedures for goods, reporting in writing to the Customs at the border gate where the goods are expected to be cleared to stop the customs clearance procedures and the agency that issued the circulation number to revoke the circulation number;
b) After receiving a request from the owner of the circulation number or after receiving a document to revoke the medical equipment classification, the customs authority shall be responsible for stopping customs clearance procedures; the authority that issued the circulation number shall be responsible for carrying out the procedure to revoke the circulation number.
3. In case the medical equipment has been granted a circulation number but uses a classification result that has been issued a recall document by the Ministry of Health and has undergone customs clearance procedures but has not yet been sold to users:
a) The owner of the circulation number is responsible for:
– Stop the circulation of medical equipment and take measures to recall medical equipment with circulation numbers whose circulation number issuance dossiers use the classification results that have been issued a recall document by the Ministry of Health;
– Report in writing to the customs authority where the goods have been cleared, clearly stating the quantity of medical equipment cleared and not carrying out import procedures for subsequent shipments;
- Report in writing to the agency that issued the circulation number, clearly stating the quantity of medical equipment cleared through customs and sales contracts (if any);
– Re-register the circulation number.
b) After receiving a request document from the owner of the circulation number or after receiving a document withdrawing the medical equipment classification:
– The customs authority is responsible for not handling customs clearance procedures;
– The agency that issued the circulation number is responsible for carrying out the procedure to revoke the circulation number.
4. In case medical equipment has been sold to medical facilities:
a) The owner of the circulation number is responsible for:
- Report in writing to the agency that issued the circulation number, clearly stating the quantity of medical equipment sold to medical facilities;
– Notify in writing the medical facilities where the medical equipment is being used.
b) In case the medical equipment has been granted a circulation number but uses a false classification result but does not potentially affect the patient's health: The medical facility is allowed to continue using that medical equipment and the owner of the circulation number is responsible for completing the medical equipment circulation records at the medical facility after receiving a new circulation number;
c) In case the medical equipment has been granted a circulation number but uses a false classification result that has the potential to affect the patient's health: The medical facility must not continue to use that medical equipment and the owner of the circulation number is responsible for taking remedial measures to ensure the normal operation of the medical facility.
Chapter III
MEDICAL EQUIPMENT MANUFACTURING
Article 11. Investment incentives for medical equipment manufacturing activities
1. Exemption and reduction of State land rent:
a) Investors with type B medical equipment manufacturing projects when leasing land from the State shall be subject to the lowest price prescribed by the People's Committee of a province or centrally-run city (hereinafter referred to as the province) and shall be exempted from land rent according to the provisions of law;
b) Investors with medical equipment manufacturing projects of type C and D are exempted from land rent from the date the project is completed and put into operation;
c) Investors with medical equipment manufacturing projects are exempted from land rent for land areas used for building housing for workers, land for planting trees and land serving public welfare.
2. In addition to the investment incentives prescribed in Clause 1 of this Article, medical equipment manufacturing projects shall also enjoy other investment incentives prescribed by law on investment, science and technology.
Article 12. Personnel conditions of medical equipment manufacturing facilities
1. Conditions of the professional in charge:
a) 5 Have a college degree in medical equipment engineering or higher, or a university degree in engineering, medicine, or pharmacy or higher. For facilities manufacturing medical equipment containing narcotic substances and precursors, the person in charge of the expertise must have a university degree in medical equipment, medicine, pharmacy, chemistry, or biology;
b) Have at least 24 months of direct working experience in medical equipment engineering at medical equipment facilities;
c) Work full-time at the production facility. The assignment and appointment of the person in charge of the production facility's expertise must be stated in writing.
2.6 (repealed).
Article 13. Conditions on quality management of medical equipment manufacturing facilities
1. Meet the quality management system standards as prescribed in Clause 1, Article 68 of this Decree.
2. For establishments manufacturing medical equipment containing narcotic substances and precursors, in addition to meeting the conditions specified in Clause 1 of this Article, there must be a system to monitor and manage the process of exporting, importing, storing, and using raw materials that are narcotic substances and precursors, the process of exporting, importing, storing medical equipment containing narcotic substances and precursors, and a storage warehouse that meets the provisions of Article 7 of Decree No. 80/2001/ND-CP dated November 5, 2001 of the Government guiding the control of legal activities related to drugs in the country (hereinafter referred to as Decree 80/2001/ND-CP).
Article 14. Dossier for declaration of eligibility to manufacture medical equipment
The dossier declaring eligibility to manufacture medical equipment includes:
1. Document declaring eligibility for production according to form No. 02 specified in Appendix I issued with this Decree.
2. Personnel declaration form according to the form prescribed in Appendix II issued with this Decree.
3. Document assigning and appointing the person in charge of the production facility's expertise, accompanied by a confirmation of working time according to the form prescribed in Appendix III issued with this Decree and the diploma or training certificate of the person in charge of expertise.
4.8 Certificate of quality management standards recognized by a conformity assessment organization in accordance with the provisions of law.
In case the facility does not conduct product quality inspection itself or does not have a warehouse or means of transportation but signs a contract for quality inspection, storage, and transportation with another facility, it must attach documents proving that the facility is qualified to conduct quality inspection, storage, and transportation of the medical equipment it produces.
5.9 Documents proving satisfaction of the conditions specified in Clause 2, Article 13 of this Decree.
Article 15. Requirements for dossiers declaring eligibility to manufacture medical equipment
1. The dossier for declaring eligibility to manufacture medical equipment is made into 01 set, including:
a) Documents in the file are clearly printed and arranged in the order prescribed in Article 14 of this Decree; there are separations between sections, page three and a list of documents;
b) Documents not in English must be translated into Vietnamese.
2. Requirements for some documents in the dossier for declaring eligibility for production:
a) Original or certified copy of assignment, appointment document, diploma, training certificate of the person in charge of the production facility's expertise;
b) 10 (abolished).
c) Original or certified copy or certified copy of the Certificate of meeting quality management standards of the facility requesting the declaration of eligibility for production.
Article 16. Procedures for declaring eligibility to manufacture medical equipment
1. The facility is only allowed to manufacture medical equipment after the Department of Health has issued a receipt for the dossier declaring eligibility for production as prescribed in Point b, Clause 2 of this Article.
2. Procedures for declaring eligibility for production:
a) Before manufacturing medical equipment, medical equipment manufacturing facilities are responsible for submitting a dossier declaring eligibility for manufacturing as prescribed in Article 14 of this Decree to the Department of Health where the factory or manufacturing plant is located;
b) Upon receiving a complete and valid dossier, the Department of Health shall issue to the facility the Receipt of dossier declaration of eligibility for production according to Form No. 02 specified in Appendix IV issued together with this Decree. In case the facility declares to produce medical equipment containing narcotic substances and precursors, the Department of Health shall be responsible for sending a copy of the Receipt of dossier declaration of eligibility for production to the Ministry of Public Security.
3. Adjust information in the declaration of eligibility to manufacture medical equipment:
a) Cases where information in the declaration dossier for eligibility to manufacture medical equipment is adjusted:
– Change of professional manager of the production facility;
– Change address, contact phone number.
b) Application for adjusting information in the declaration of eligibility to manufacture medical equipment:
– A written request for adjustment according to Form No. 20 specified in Appendix I issued with this Decree, which must clearly state the content of the change;
– In case of change of professional manager: Documents specified in Clause 3, Article 14 of this Decree;
– In case of change of address or contact phone number: Documents proving the change of address or phone number of the manufacturing facility.
c) Adjustment procedure:
– After receiving the application for adjustment of information in the dossier declaring eligibility to manufacture medical equipment, the Department of Health shall issue to the facility a Receipt of adjustment of dossier declaring eligibility to manufacture medical equipment according to Form No. 14 specified in Appendix IV issued with this Decree;
– Within 03 working days from the date recorded on the Receipt of Adjustment of Production Eligibility Declaration, the Department of Health is responsible for updating the changed information on the electronic information portal. In case the Department of Health does not accept, it must reply in writing and state the reasons.
4. During operation, the production facility must re-conduct the procedure for declaring eligibility for production if there is any change related to the previously declared dossier that does not fall under the case specified in Point a, Clause 3 of this Article.
5. In case a manufacturing facility changes its manufacturing location from one province to another, it must notify the Department of Health where the manufacturing facility has made the declaration of eligibility for manufacturing within 10 working days from the date of change of manufacturing location.
Within 03 working days from the date of receiving the notice of the production facility's change of production location to another province, the Department of Health that received the dossier declaring eligibility for production shall be responsible for stopping the posting of information related to that facility.
Chapter IV
CIRCULATION OF MEDICAL EQUIPMENT
Section 1. CIRCULATION CONDITIONS, CIRCULATION NUMBER AND CONDITIONS OF THE ORGANIZATION PUBLISHING THE APPLIED STANDARDS OR REGISTERING FOR CIRCULATION
Article 17. Conditions for circulation of medical equipment
1. Medical equipment when circulating on the market must meet the following conditions:
a) 12 Have a circulation number or have been granted an import license according to the provisions of this Decree, except for medical gases;
b) Have a label or be accompanied by a sub-label with full information as prescribed in Article 54 of this Decree;
c) Have technical documents to serve the repair and maintenance of medical equipment, except for single-use medical equipment as prescribed by the owner of the medical equipment;
d) There is information on instructions for use of medical equipment in Vietnamese;
d)13 There is information on the warranty facility, conditions and warranty period, except for single-use medical equipment as prescribed by the owner of the medical equipment or there is documentation proving that there is no warranty;
2. In case the information specified in Points c, d and dd Clause 1 of this Article is not included with the medical equipment, it must be provided in the form of electronic information and instructions for looking up information must be clearly shown on the medical equipment label.
Article 18. Conditions for publishing applicable standards or granting circulation registration certificates for medical equipment
1. Conditions for publishing applicable standards or granting a certificate of registration for circulation of medical equipment:
a) Manufactured at a manufacturing facility that has declared sufficient production conditions for domestically produced medical equipment;
b) Manufactured at a manufacturing facility that has been granted a Certificate of meeting quality management standards and is allowed to circulate in any country in the world for imported medical equipment;
c) Comply with national technical regulations or standards announced by the manufacturer.
2. It is not allowed to re-perform the procedure of declaring applicable standards or registering for circulation for medical equipment in one of the following cases:
a) Medical equipment falling under the cases prescribed in Clause 1, Article 34 of this Decree;
b) Medical equipment is recalled in the cases prescribed in Clauses 1 and 3, Article 35 of this Decree.
3. Do not accept dossiers for declaration of applicable standards or registration for circulation within 12 months from the date of decision to revoke the registration number for circulation of medical equipment falling into one of the cases specified in Clauses 2 and 8, Article 35 of this Decree.
Article 19. Medical equipment exempted from publication of applicable standards and registration for circulation
1. Medical equipment is only for the purpose of research, testing, instruction on use and repair of medical equipment.
2. Medical equipment imported into Vietnam for aid purposes or to serve fairs, exhibitions, displays, product introductions or for use as gifts.
3. Medical equipment manufactured in Vietnam is only for export purposes or for participation in exhibitions, fairs and exhibitions abroad.
Article 20. Circulation number of medical equipment
1. The circulation number of medical equipment is:
a) Number of receipts for dossiers declaring applicable standards for medical equipment of type A according to form No. 03 specified in Appendix IV issued with this Decree.
b) Registration certificate number for medical equipment of type B, C, D according to form No. 09 specified in Appendix IV issued with this Decree.
2. The medical equipment circulation number may be issued to one or a group of medical equipment types.
3. The owner of the circulation number is the organization that publishes the standards applicable to medical equipment of type A or the organization that is granted the circulation number for medical equipment of type B, C, D.
4. Validity of circulation number:
a) The circulation number of type A medical equipment is valid indefinitely;
b) The circulation number of medical equipment of type B, C, D is valid for 05 years from the date of issue. In case the circulation number of medical equipment is extended, the previously issued circulation number will remain.
Article 21. Conditions for organizations to be named in the announcement of applicable standards or registration of circulation of medical equipment
1. Organizations authorized to publish applicable standards or register the circulation of medical equipment include:
a) Vietnamese enterprises, cooperatives and business households are owners of medical equipment;
b) Vietnamese enterprises, cooperatives, and business households with the function of trading in medical equipment are authorized to register by the owner of the medical equipment;
c) Permanent representative office in Vietnam of a foreign trader that is the owner of the medical equipment or is authorized by the owner of the medical equipment.
2. The organization that announces the applicable standards or registers the circulation of medical equipment must have a warranty facility in Vietnam or must have a contract with an organization that is qualified to provide warranty for the medical equipment it registers, except for single-use medical equipment as prescribed by the owner of the medical equipment.
In case the organization that announces the applicable standards or registers the circulation of medical equipment subject to the provisions of Point c, Clause 1 of this Article, the owner of the medical equipment must have a warranty facility in Vietnam or must have a contract with a facility that is qualified to provide warranty for the medical equipment that it announces or registers, except for the case of single-use medical equipment as prescribed by the owner of the medical equipment.
The warranty facility must be certified by the owner of the medical equipment as having the capacity to warranty the product for which the organization is applying for a circulation number.
Section 2. ANNOUNCEMENT OF STANDARDS APPLICABLE TO TYPE A MEDICAL EQUIPMENT
Article 22. Dossier for declaration of applicable standards14
The dossier declaring the applicable standards for medical equipment of type A includes:
1. Document announcing the applicable standards of medical equipment of type A according to Form No. 03 specified in Appendix I issued with this Decree.
2. Classification of medical equipment according to the form prescribed in Appendix V issued with this Decree.
3. The certificate of meeting quality management standards is still valid at the time of application submission. For domestically produced medical equipment, there must be an additional Receipt of application for declaration of eligibility to manufacture medical equipment.
4. The authorization letter of the owner of the medical equipment for the organization that declares the applicable standards according to the form prescribed in Appendix VI issued with this Decree is still valid at the time of dossier submission, except for the case prescribed in Point a, Clause 1, Article 21 of this Decree.
5. Certificate of eligibility for warranty issued by the owner of the medical equipment according to the form specified in Appendix VII issued with this Decree, except for cases of single-use medical equipment as prescribed by the owner of the medical equipment or with documents proving that there is no warranty.
6. Documents summarizing the technical description of medical equipment in Vietnamese according to Form No. 01 specified in Appendix VIII issued with this Decree, together with technical documents describing the functions and technical parameters of the medical equipment issued by the owner of the medical equipment.
Particularly for reagents, calibrators, and in vitro control materials: technical documents in Vietnamese according to Form No. 02 specified in Appendix VIII issued with this Decree, together with documents on raw materials, product safety, manufacturing processes, clinical and preclinical research reports including stability reports.
7. Certificate of conformity according to regulations or product standard published by the owner of the medical equipment, accompanied by the results of the assessment of chemical, physical, microbiological parameters and other parameters issued by a qualified facility according to the provisions of law on conformity assessment for domestically produced medical equipment. The assessment results must be consistent with the standards published by the owner.
8. Instructions for use of medical equipment.
9. Label sample to be used when circulating in Vietnam of medical equipment.
10. The free circulation certificate is still valid at the time of application submission for imported medical equipment.
Article 23. Requirements for dossiers declaring applicable standards
1. The dossier for declaring applicable standards is made into 01 set.
2. Requirements for some documents in the application standard declaration dossier:
a) For the Receipt of dossier for declaration of eligibility for production: Submit a copy certified by the organization declaring the applicable standards.
b)15 For Certificate of meeting quality management standards: Submit the original or a certified copy or a copy certified by the organization that announced the applicable standards;
In case the Certificate of Quality Management Standards is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.
c) For the authorization letter of the owner of medical equipment and the certificate of the facility eligible for warranty:
– For domestically produced medical equipment: Submit the original or a certified copy;
– For imported medical equipment: Submit a consularly legalized copy or a certified copy of the consularly legalized copy.
d) For the Certificate of Conformity or Standard that the owner of the medical equipment declares to apply: Submit a copy certified by the organization declaring the applicable standard.
In case the Standard is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law;
d) For medical equipment instruction manuals: Submit a Vietnamese copy certified by the organization that publishes the applicable standards;
e) For label samples: Submit a certified copy of the label sample from the organization that announced the applicable standards. The label sample must meet the requirements specified in Article 54 of this Decree.
g)16 For the certificate of free circulation: Submit the consularly legalized copy or a certified copy of the consularly legalized copy.
In case the certificate of free sale is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.
In case the certificate of free circulation does not clearly state the expiration date, the expiration date of the certificate of free circulation is calculated as 36 months from the date of issue.
Article 24. Procedures for announcing applicable standards
1. Type A medical equipment may only be circulated on the market after the Department of Health has issued a receipt for the application for declaration of applicable standards as prescribed in Point b, Clause 2 of this Article.
2. Procedures for announcing applicable standards:
a) Before putting medical equipment of type A into circulation on the market, the facility responsible for putting medical equipment on the market is responsible for submitting a dossier declaring applicable standards as prescribed in Article 22 of this Decree to the Department of Health where the facility is headquartered;
b) Upon receiving a complete and valid dossier, the Department of Health shall issue to the facility implementing the announcement a Receipt of dossier for announcement of applicable standards according to form No. 03 specified in Appendix IV issued with this Decree;
c) Within 03 working days from the date recorded on the Dossier Receipt Form, the Department of Health is responsible for publicizing on the electronic information portal the following information: name, classification, manufacturing facility, country of manufacture of medical equipment; circulation number of medical equipment; name and address of the owner of the circulation number; name and address of the medical equipment warranty facility and the dossier declaring the applicable standards of the medical equipment.
3. In case of change of owner of medical equipment; name, manufacturing facility, country of manufacture of medical equipment, the owner of the circulation number is responsible for re-announcing the applicable standards according to the provisions of this Decree.
4.17 During the circulation of medical equipment, the owner of the circulation number is responsible for notifying the Circulation Number Issuing Authority within 10 working days from the date of one of the following changes:
a) Change of address of medical equipment owner or medical equipment circulation number owner;
b) Change the name of the circulation number owner. The circulation number owner is responsible for sending a written notice of change along with supporting documents and label samples as prescribed in Article 54 of this Decree;
c) Change one of the information about the name and address of the medical equipment manufacturing facility. The owner of the circulation number is responsible for submitting the following documents in writing to notify the change: Free circulation certificate and Certificate of meeting quality management standards that are still valid at the time of application submission;
d) Change the packaging specifications for in vitro diagnostic medical devices. The owner of the circulation number is responsible for submitting the notification of change of documents as prescribed in Clauses 6 and 9, Article 22 of this Decree;
d) Change of warranty facility. The owner of the circulation number is responsible for sending along with the notice of change the documents as prescribed in Clause 5, Article 22 of this Decree;
e) Change the label, change the instructions for use but do not change the indication. The owner of the circulation number is responsible for sending along with the notice of change the documents corresponding to the changed content.
Section 3. CIRCULATION REGISTRATION FOR MEDICAL EQUIPMENT OF TYPES B, C, D
Article 25. Forms of registration for circulation18
1. New circulation number issuance applies to medical equipment in the following cases:
a) Medical equipment first request for circulation number;
b) Medical equipment has been granted a circulation number but has one of the following changes: Type of medical equipment; manufacturing materials affect the function of in vitro diagnostic medical equipment and disposable medical equipment;
c) Medical equipment has been granted a circulation number but has not registered for an extension of the circulation number within the time limit prescribed in Clause 3, Article 27 of this Decree.
2. Quickly issue new circulation registration numbers for medical equipment in the following cases:
a) Medical equipment has been circulated in at least 02 countries in the following countries: Japan, Canada, Australia, USA, EU member countries;
b) Has been circulated in Vietnam before December 31, 2018 and meets the following conditions:
– Has been in circulation for at least 03 years within 05 years from the date of application submission;
– There is no warning information regarding the quality and safety of that medical device.
3. Extension of the circulation number applies to cases where the circulation number is about to expire according to the provisions of Clause 3, Article 27 of this Decree.
Article 26. Application for new circulation number
1.19 Application for new circulation number for medical equipment that does not have corresponding national technical regulations:
a) Document requesting issuance of new circulation number according to Form No. 04 specified in Appendix I issued with this Decree;
b) Classification of medical equipment according to the form prescribed in Appendix V issued with this Decree;
c) Certificate of quality management standards valid at the time of application submission;
d) The authorization letter of the owner of the medical equipment for the facility to carry out the circulation registration according to the form prescribed in Appendix VI issued with this Decree, which is still valid at the time of dossier submission, except for the case prescribed in Point a, Clause 1, Article 21 of this Decree;
d) Certificate of eligibility for warranty issued by the owner of the medical equipment according to the form specified in Appendix VII issued with this Decree, except for cases of single-use medical equipment as prescribed by the owner of the medical equipment or with documents proving that there is no warranty;
e) Free circulation certificate valid at the time of application submission for imported medical equipment;
g) Documents summarizing the technical description of medical equipment in Vietnamese according to Form No. 01 specified in Appendix VIII issued with this Decree, together with technical documents describing the functions and technical parameters of the medical equipment issued by the owner of the medical equipment;
Particularly for reagents, calibrators, and in vitro control materials: technical documents in Vietnamese according to Form No. 02 specified in Appendix VIII issued with this Decree, together with documents on raw materials, product safety, manufacturing processes, clinical and preclinical research reports including stability reports;
h) General technical dossiers are implemented according to the instructions in the ASEAN Agreement on Medical Devices;
i) User manual of medical equipment;
k) For medical devices of type C and D that penetrate the human body: Summary of clinical trial data according to the form prescribed in Appendix IX issued with this Decree, together with the results of clinical trial research, except in the following cases:
– Medical equipment that has been circulated and granted a certificate of free circulation by one of the following countries: EU member countries, Japan, Canada, Australia (TGA), USA (FDA);
– Medical equipment that has been granted circulation before this Decree takes effect;
– Other cases as prescribed by the Minister of Health.
l) For in vitro diagnostic medical equipment of type C and D, there must be an additional inspection certificate according to the regulations of the Minister of Health, except in the following cases:
– Medical equipment has been granted a certificate of free circulation by one of the following countries: EU member countries, Japan, Canada, Australia (TGA), USA (FDA);
– Medical equipment that has been granted circulation before this Decree takes effect;
m) Label sample to be used when circulating in Vietnam of medical equipment;
n) Receipt of dossier for declaration of eligibility for production in accordance with the product applying for circulation registration number for domestically produced medical equipment;
o) Report on business performance within the period of being granted a circulation number according to Form No. 01 specified in Appendix X issued with this Decree for medical equipment that has been granted circulation before this Decree takes effect and is exempt from submitting a summary of clinical trial data or from an inspection certificate.
2. Application for new circulation registration number for medical equipment with corresponding national technical regulations:
a) Document requesting the issuance of a new circulation registration number according to form No. 04 specified in Appendix I issued with this Decree;
b) Certificate of conformity;
c)20 Documents as prescribed in points b, c, d, dd, e, g, h, i, m, n and o, Clause 1 of this Article.
3. Application for new circulation number issuance for medical equipment that is a measuring instrument must have sample approval according to regulations of law on measurement:
a) Document requesting the issuance of a new circulation registration number according to form No. 04 specified in Appendix I issued with this Decree;
b) Decision to approve the sample;
c)21 Documents as prescribed in points b, c, d, dd, e, g, h, i, m, n and o, Clause 1 of this Article.
4. The application for a new circulation number for medical equipment that is a measuring instrument but does not require sample approval according to the provisions of the law on measurement shall be implemented according to the provisions in Clause 1 of this Article.
5.22 Application for quick issuance of circulation number:
a) For the case specified in Point a, Clause 2, Article 25:
The documents specified in Clause 1 of this Article and at least 01 certificate of free circulation from a competent authority of one of the following countries: EU member countries, Japan, Canada, Australia (TGA), USA (FDA) valid at the time of application submission;
b) For the case specified in Point b, Clause 2, Article 25:
The documents specified in Clause 1 of this Article and the following additional documents:
– Have at least 03 contracts to supply medical equipment with medical facilities in Vietnam;
– Confirmation document from the medical facility that the medical equipment has no warning information related to the quality and safety of the medical equipment during use.
Article 27. Dossier for re-issuance and extension of circulation number
1. Application for re-issuance of circulation number in case of loss or damage: Application for re-issuance of circulation number according to form No. 05 specified in Appendix I issued with this Decree.
2. Application for extension of circulation number includes:
a) Document requesting to extend the circulation number according to form No. 06 specified in Appendix I issued with this Decree;
b) A copy of the issued circulation registration certificate;
c)23 Certificate of quality management standards valid at the time of application submission;
d) Authorization letter from the owner of the medical equipment for the facility to carry out the registration for circulation according to the form prescribed in Appendix VI issued with this Decree, except for the case prescribed in Point a, Clause 1, Article 21 of this Decree;
d) Certificate of free circulation for imported medical equipment that is still valid at the time of application submission;
e) Report on business performance within the period of circulation number issuance according to the form prescribed in Appendix X issued with this Decree;
g)24 The common technical dossier is implemented according to the guidance in the ASEAN Agreement on Medical Devices for cases where a circulation number has been granted but at the time of granting the circulation number, the law does not stipulate that the application for the circulation number must have a common ASEAN technical dossier.
3. The deadline for submitting applications for renewal of circulation number is at least 60 days before the circulation number expires.
Article 28. Requirements for application dossiers for new issuance or extension of circulation number
1. The application for new issuance or extension of medical equipment circulation number shall be made into 01 set, the documents in the application shall be clearly printed, arranged in the order prescribed in Article 26 of this Decree for the application for new issuance of circulation number or according to the provisions of Clause 2, Article 27 of this Decree for the application for extension of circulation number; there shall be separation between documents, page three and list of documents.
2. Requirements for some documents in the registration dossier:
a)25 For Certificate of meeting quality management standards: Submit the original or a certified copy or a copy confirmed by the facility requesting the circulation number.
In case the Certificate of Quality Management Standards is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.
b) For the authorization letter of the owner of medical equipment and the certificate of the facility eligible for warranty:
– For domestically produced medical equipment: Submit the original or a certified copy;
– For imported medical equipment: Submit a consularly legalized copy or a certified copy of the consularly legalized copy.
c) For the certificate of free circulation: Submit the consularly legalized copy or a certified copy of the consularly legalized copy.
In case the certificate of free sale is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.
In case the certificate of free circulation does not clearly state the expiration date, the expiration date of the certificate of free circulation is calculated as 36 months from the date of issue.
d) For technical documents of medical equipment: Submit a copy certified by the organization requesting the circulation number.
In case the technical documents are not in English or Vietnamese, they must be translated into Vietnamese. The translation must be certified according to the provisions of law;
d) For medical equipment instruction manuals: Submit a Vietnamese copy certified by the organization requesting the circulation number.
e)26 For inspection certificate: Submit the original or a certified copy or a copy confirmed by the facility requesting the circulation number.
g) For label samples: Submit a certified copy of the label sample from the organization registering the circulation. The label sample must meet the requirements specified in Article 54 of this Decree.
Article 29. Receiving and appraising medical equipment circulation registration dossiers
1. Organizations requesting a circulation number submit their application to the Ministry of Health.
2. After receiving the registration dossier, the Ministry of Health shall send the organization requesting the issuance of a circulation number a Receipt of the registration dossier for medical equipment circulation according to form No. 04 specified in Appendix IV issued with this Decree. The dossier shall not be accepted in case the registration dossier does not meet the requirements specified in Article 28 of this Decree.
3. In case there is no request to amend or supplement the registration dossier, the Minister of Health is responsible for:
a) For medical equipment that does not have a corresponding national technical regulation: the appraisal organization shall issue a new circulation number within 60 days or extend the circulation number within 30 days from the date stated on the Application Receipt Form. In case of not issuing a new circulation number or extending the circulation number, there must be a written response stating the reason;
b) For medical equipment with corresponding national technical regulations: the appraisal organization shall issue a new circulation number within 15 days or extend the circulation number within 10 days from the date stated on the Application Receipt Form. In case of not issuing a new circulation number or extending the circulation number, there must be a written response stating the reason;
c) Re-issue the circulation number within 05 working days from the date recorded on the Application Receipt Form. In case of not re-issuing the circulation number, there must be a written reply stating the reason;
d)27 Organize appraisal to issue new circulation numbers within 30 days from the date recorded on the Application Receipt Form for cases specified in Clause 2, Article 25 of this Decree.
4. In case the registration dossier is not complete, the Ministry of Health must issue a written notice to the organization requesting the issuance, re-issuance, or extension of the circulation number to supplement or amend the registration dossier, which must specifically state which documents need to be supplemented and which content needs to be amended within the time limit:
a) 15 working days from the date recorded on the Application Receipt for applications for new issuance or extension of circulation number;
b) 05 working days from the date recorded on the Application Receipt for applications for re-issuance of circulation number.
5.28 Upon receiving a document requesting to supplement or amend the application for a circulation number, the facility requesting the circulation number must supplement or amend in accordance with the contents stated in the document and send it to the Ministry of Health;
In case the facility requesting the issuance of a circulation number has supplemented or modified the dossier but it does not meet the requirements, the Ministry of Health will notify the facility to continue completing the dossier according to the provisions of Clause 4 of this Article;
After 90 days from the date the Ministry of Health issues a written request, if the facility does not supplement or amend the dossier, or if after 05 times of amending or supplementing the dossier from the date the Ministry of Health first requests for amendment or supplement, the dossier still does not meet the requirements, the procedure for requesting a circulation number must be re-conducted from the beginning;
During the process of amending and supplementing the dossier, if the documents specified in Points c, d, e, Clause 1, Article 26 expire, the organization or individual requesting the issuance of a circulation registration number must submit additional valid replacement documents. These documents must meet the requirements specified in Article 28 of this Decree.
6. In case the appraisal council requests amendments or supplements to the dossier, within 10 working days from the date of the council meeting minutes, the Ministry of Health shall issue a written notice to the organization requesting the issuance of a circulation number to supplement the dossier. The written notice must specify which documents need to be supplemented and which content needs to be amended.
Upon receiving a document requesting to supplement or amend the registration dossier, the organization requesting the issuance of a circulation number must supplement or amend it in accordance with the contents stated in the document and send it to the Ministry of Health. The date of receipt of the supplementary or amended dossier is recorded on the Dossier Receipt Form.
In case the organization requesting the issuance of a circulation number has supplemented or modified the dossier but it does not meet the requirements, the Ministry of Health will notify the organization requesting the issuance of a circulation number to continue completing the dossier according to the provisions in Clauses 4 and 5 of this Article.
7. Within 03 working days from the date of issuance of the circulation number, the Ministry of Health is responsible for publicizing the following information on the Ministry of Health's electronic information portal:
a) Name, classification, manufacturing facility, and country of manufacture of medical equipment;
b) Circulation number of medical equipment;
c) Name and address of the owner of the medical equipment;
d) Name and address of the owner of the circulation number;
d) Name and address of the medical equipment warranty facility;
e) Registration dossier for circulation of medical equipment, except for information as prescribed in Point h, Clause 1, Article 26 of this Decree.
8. During the process of circulating medical equipment, the owner of the circulation number is responsible for sending a written notification to the Ministry of Health within 10 working days from the date of one of the following changes:
a) Change of address of medical equipment owner or medical equipment circulation number owner;
b) Change of name of circulation number owner. The circulation number owner is responsible for submitting with the notice of change documents proving the ownership of the medical equipment of the new owner and the label sample as prescribed in Article 54 of this Decree;
c)29 Change one of the information on the name and address of the medical equipment manufacturing facility. The owner of the circulation number is responsible for submitting the following documents with the notice of change: Free circulation certificate and Certificate of meeting quality management standards that are still valid at the time of application submission;
d)30 Changes in packaging specifications for in vitro diagnostic medical devices. The owner of the circulation number is responsible for submitting documents corresponding to the change content along with the notification of change;
d) Change of warranty facility. The owner of the circulation number is responsible for sending along with the notice of change the documents as prescribed in Point d, Clause 1, Article 26 of this Decree;
e)31 Changing the label, changing the instructions for use but not changing the indication: The owner of the circulation number is responsible for sending along with the notice of change the documents corresponding to the changed content.
9. Within 03 working days from the date of receipt of the notification from the circulation number owner, the Ministry of Health is responsible for updating the changed information in the medical equipment management records and on the electronic information portal.
10. The Minister of Health shall prescribe the appraisal of application dossiers for circulation number issuance as prescribed in Clause 3 of this Article.
Section 4. POST-SALES MANAGEMENT OF MEDICAL EQUIPMENT AND HANDLING OF MEDICAL EQUIPMENT IN SOME SPECIAL CASES
Article 30. Requirements for post-sales medical equipment management records32
The owner of the circulation number must establish, organize and manage the traceability of medical equipment on the market and fully store equipment management records, including at least:
1. Medical equipment circulation registration dossier, in which it is mandatory to keep paper copies of the following documents:
a) Authorization letter from the owner of the medical equipment for the facility to carry out the circulation registration, except for the case specified in Point a, Clause 1, Article 21 of this Decree;
b) Certificate of eligibility for warranty issued by the owner of the medical equipment, except for single-use medical equipment as prescribed by the owner of the medical equipment or with documents proving that there is no warranty;
c) Certificate of free circulation.
2. Distribution records (in case the owner of the circulation number is a Representative Office, it is not required to store it but must request the facility it authorizes to import to perform this responsibility).
3. Records of incidents, complaints and corrective and handling measures; including identifying the name, type, quantity, and batch number of medical equipment; especially for medical equipment that is defective or poses a risk to user safety.
4. Medical equipment quality management records, including:
a) Certificate of origin is implemented according to Decree No. 31/2018/ND-CP dated March 8, 2018 of the Government detailing the Law on Foreign Trade Management on origin of goods;
b) Quality certificate of each batch issued by the owner of the medical equipment or the manufacturer named in the medical equipment circulation registration dossier;
c) Results of medical equipment inspection for medical equipment in the cases specified in Clause 1, Article 49 of this Decree.
Article 31. Handling of cases where medical equipment has warnings of potential risks that seriously threaten public health or may lead to death for users33
1. In case a medical device has a warning from a competent authority of Vietnam or international about a potential risk that seriously threatens public health or can lead to death for the user, the owner of the circulation number is responsible for notifying the medical facilities using the medical device about the warned risk and conducting an investigation and determination within 30 days from the date of receiving the warning. In case the investigation and determination must last more than 30 days, a written report must be sent to the Ministry of Health, clearly stating the cause and proposing solutions to ensure safety for the user.
2. In case the medical equipment in Clause 1 of this Article is determined to be defective medical equipment that affects the health of users, the owner of the circulation number shall be responsible for:
a) Temporarily suspend the circulation of that batch of medical equipment;
b) Issue a written notice to the Ministry of Health and organizations and individuals that are distributing and using such medical equipment. The written notice must clearly state the production batch, the defective factor that adversely affects the health of the user, as well as whether or not that factor can be corrected;
c) Develop a plan to handle, correct, or recall defective batches of medical equipment;
d) Report to the Ministry of Health after completing the repair or recall of medical equipment.
3. In case the medical equipment can fix the error that affects the user's health:
a) Within 03 working days from the date of receiving the notification from the owner of the medical equipment circulation number, the Ministry of Health shall be responsible for issuing a decision to suspend the circulation of the batch of medical equipment;
The contents of the decision to suspend circulation include:
– Name of the suspended medical device;
– Number of batches of suspended medical equipment;
– Circulation number of suspended medical equipment.
b) After the decision to suspend the circulation of a batch of medical equipment is made, the owner of the circulation number is responsible for correcting the defective factor that affects the health of the product users;
c) After completing the correction of the error factor affecting the user's health, the owner of the circulation number is responsible for sending a written report to the Ministry of Health with the inspection results for the case of medical equipment subject to the provisions of Clause 1, Article 49 of this Decree or must include a commitment to ensure the quality of the medical equipment after the error has been corrected in the written report for other medical equipment;
d) Within 20 days from the date of receipt of the report on the correction of the defect affecting the health of users of the batch of medical equipment sent by the owner of the circulation number, the Ministry of Health shall be responsible for issuing a decision to terminate the suspension of circulation of the batch of medical equipment. In case the Ministry of Health does not agree to terminate the suspension of circulation, it must issue a written response, clearly stating the reason for the refusal.
4. In case the medical equipment cannot fix the faulty factor that adversely affects the user's health:
a) The Ministry of Health is responsible for issuing a decision to recall the entire batch of defective medical equipment.
The contents of the revocation decision include:
– Name of the medical equipment being recalled;
– Batch number of recalled medical equipment;
– Circulation number of recalled medical equipment.
b) The owner of the circulation number is responsible for recalling the entire batch of defective medical equipment within the time limit decided by the competent state agency and bears all costs for recalling the batch of defective medical equipment.
c) In case the recall period according to the decision of the competent state agency has expired but the owner of the circulation number has not recalled the defective batch of medical equipment, the recall shall be forced according to the provisions of the law on handling of administrative violations.
Article 32. Handling of cases where medical equipment has had an incident that affects the health of the user34
1. In case a medical device has an incident that seriously threatens public health or causes death to the user, the owner of the circulation number is responsible for:
a) Announce on the electronic information page of the circulation number owner (if any) and at the same time send a written notice of the incident to the establishments purchasing and using the batch of medical equipment and the Ministry of Health;
b) Temporarily suspend the circulation of the batch of medical equipment related to the incident;
c) Conduct investigation and verify the cause of the incident;
d) Report to the Ministry of Health after the investigation and verification results are available. In case the incident is determined to be due to a defect in the medical equipment, the defect must be clearly stated as well as whether or not it can be remedied. Carry out the remediation or recall of the defective batch of medical equipment, and report to the Ministry of Health after completing the remediation or recall of the batch of medical equipment.
2. In case a medical device has an incident that does not cause death but has a serious impact on the health of the user, the owner of the circulation number is responsible for:
a) Notify the Ministry of Health in writing of the incident;
b) Conduct investigation and verify the cause of the incident;
c) Report to the Ministry of Health after the investigation and verification results are available. In case the incident is determined to be due to a medical device defect, the defect factor must be clearly stated as well as whether or not it can be corrected. Carry out the correction or recall of the defective batch of medical devices, and report to the Ministry of Health after completing the correction or recall of the batch of medical devices.
3. The handling of defective medical equipment that affects the health of users shall comply with the provisions in Clauses 3 and 4, Article 31 of this Decree.
Article 33. Forms of handling, remedying and recalling defective medical equipment35
1. Forms of handling defective medical equipment include:
a) Instructions on error correction measures;
b) Troubleshooting of medical equipment;
c) Replace defective medical equipment with equivalent medical equipment;
d) Recall for re-export or destruction.
2. Defective medical equipment is recalled in the following forms:
a) Voluntary recall by the owner of the circulation number;
b) Compulsory revocation in cases prescribed in Article 35 of this Decree.
Article 34. Handling of medical equipment when the owner of the medical equipment or the owner of the medical equipment circulation number stops production or goes bankrupt or dissolved
1. Medical equipment that has been granted a circulation number but the owner of the medical equipment declares that they will no longer manufacture or go bankrupt or dissolve, may continue to be circulated for a maximum period of no more than 24 months, from the time the owner of the medical equipment declares that they will no longer manufacture or go bankrupt or dissolve, if the owner of the circulation number in Vietnam commits to be responsible for warranty, maintenance as well as providing materials to replace or serve the use of the medical equipment for a period of 08 years, except in the case where the owner of the circulation number is a permanent representative office in Vietnam of a foreign trader that is the owner of the medical equipment.
2. Medical equipment that has been granted a circulation number but the owner of the medical equipment circulation number goes bankrupt or dissolved may continue to circulate on the market for a maximum period of no more than 24 months, from the time the owner of the medical equipment circulation number declares bankruptcy or dissolution, if the distribution facility commits to be responsible for warranty, maintenance as well as providing materials to replace or serve the use of the medical equipment for a maximum period of 08 years.
3. The owner of the circulation number or the distribution facility is responsible for sending a commitment dossier to the Ministry of Health within 60 days at the latest from the date the owner of the medical equipment or the owner of the medical equipment circulation number declares to stop production or goes bankrupt or dissolved.
4. The commitment file includes the following documents:
a) A written commitment to be responsible for warranty, maintenance and provision of materials for the use of medical equipment according to the form prescribed in Appendix XI issued with this Decree;
b) List of medical equipment with circulation numbers that the facility is keeping but the owner of the medical equipment or the owner of the medical equipment circulation number declares to stop production or is bankrupt or dissolved.
5. Within 15 working days from the date of receipt of the commitment dossier as prescribed in Clause 4 of this Article, the Ministry of Health shall be responsible for responding in writing on whether or not to permit the continued circulation of medical equipment. In case of disapproval, the reasons must be clearly stated.
6. In case the medical equipment as prescribed in Clause 1 of this Article is not permitted by the Ministry of Health to continue to be circulated, the owner of the circulation number or the distribution facility shall be responsible for recalling the medical equipment currently in circulation on the market, except for medical equipment that has been sold to users.
Section 5. REVOKING MEDICAL EQUIPMENT CIRCULATION NUMBER
Article 35. Cases of revocation of circulation numbers
1. Organizations registering for circulation of fake registration documents.
2.36 Medical equipment has 03 batches recalled during the period of validity of the circulation registration number, except in cases where the owner of the circulation registration number voluntarily recalls it.
3. The organization registering the circulation corrects or erases the content of the circulation number.
4. The owner of the circulation number ceases to operate or is no longer authorized by the owner of the medical equipment without a replacement organization, except in the case prescribed in Article 34 of this Decree.
5. Medical equipment circulating on the market does not guarantee the quality registered for circulation.
6. The circulation number is issued without proper authority, records and procedures as prescribed in this Decree.
7. Medical equipment for which the owner of the circulation registration number or the distribution facility does not have a commitment as prescribed in Clauses 1 and 2, Article 34 of this Decree.
8. Medical equipment whose circulation period has expired as prescribed in Clauses 1 and 2, Article 34 of this Decree.
9. Medical equipment manufactured at facilities that do not meet the conditions specified in this Decree.
10.37 The owner of the circulation number does not comply with the provisions in Point i, Clause 2
Article 66 of this Decree, except for the case specified in Article 34 of this Decree.
11.38 The declaration dossier of the circulation number owner does not comply with the provisions of Article 22 and Article 23 of this Decree or the case of using fake documents in the declaration dossier.
12.39 Medical equipment is classified incorrectly according to the regulations on medical equipment classification after the conclusion of the Ministry of Health.
Article 36. Procedures for revocation of circulation numbers
1. During the inspection process, if one of the cases specified in Clauses 1, 2, 3, 4, 5, 6, 8 and 9, Article 35 of this Decree is discovered, the agency conducting the inspection must make a record and send it to the Ministry of Health or the Department of Health that issued the circulation number (hereinafter referred to as the agency issuing the circulation number).
2. Within 05 working days from the date of receipt of the minutes as prescribed in Clause 1 of this Article, the circulation number issuing agency shall consider and decide on the revocation of the circulation number under its management authority.
3. After issuing a decision to revoke the circulation number, the agency issuing the revocation decision is responsible for:
a)40 Post the decision to revoke the circulation number on the electronic information portal of the circulation number issuing agency, and at the same time send the decision to revoke the circulation number to the circulation number owner, the Ministry of Health, the Department of Health of provinces and centrally run cities and the customs authority;
b) Cancel information related to medical equipment posted on the electronic portal of the circulation number issuing agency.
3. Upon receiving the decision to revoke the circulation number from the circulation number-issuing agency, the Departments of Health are responsible for posting the full text of the decision to revoke the circulation number on the electronic information portal, and at the same time direct specialized agencies to supervise the recall of medical equipment.
Chapter V
MEDICAL EQUIPMENT PURCHASE MANAGEMENT
Section 1. CONDITIONS FOR PURCHASE AND SALE OF MEDICAL EQUIPMENT
Article 37. Conditions for establishments trading in medical equipment of types B, C, D41
1. Have at least 01 technical staff with a college degree in engineering or medicine, pharmacy or medical equipment engineering or higher, or with a college degree or higher whose training major is appropriate to the type of medical equipment that the facility buys and sells;
2. Have warehouses and means of transport that meet the following minimum conditions:
a) Storage:
– Have an area suitable for the type and quantity of medical equipment being stored;
– Ensure ventilation, dry, clean, not near sources of pollution;
– Meet other storage requirements of medical equipment according to the instructions for use.
b) Means of transporting medical equipment from the trading establishment to the delivery location appropriate to the type of medical equipment being traded by the trading establishment;
In case there is no warehouse or means to store medical equipment, there must be a contract with a facility with sufficient capacity to store and transport medical equipment.
3. For establishments trading in medical equipment containing narcotic substances and precursors:
a) The person in charge of the professional must have a university degree in medical equipment, medicine, pharmacy, pharmaceutical chemistry or biology;
b) Have a warehouse that meets the regulations in Article 7 of Decree 80/2001/ND-CP;
c) Have a system to monitor and manage the export, import, and inventory of medical equipment containing narcotic substances and precursors.
Article 38. Records and procedures for declaring eligibility to purchase and sell medical equipment42
1. The dossier declaring eligibility to buy and sell medical equipment is made into 01 set including the following documents:
a) Document declaring eligibility to purchase and sell medical equipment according to Form No. 07 specified in Appendix I issued with this Decree;
b) Personnel declaration form according to the form prescribed in Appendix II issued with this Decree;
c) Documents proving that the warehouse and means of transporting medical equipment meet the requirements specified in Clause 2, Article 37 of this Decree. These documents must be certified by the facility declaring eligibility to buy and sell;
d) Documents proving that the storage warehouse, the monitoring and management system for the export, import, and inventory of medical equipment containing narcotic substances and precursors meet the requirements specified in Clause 3, Article 37 of this Decree. These documents must be certified by the establishment declaring its eligibility to buy and sell medical equipment containing narcotic substances and precursors.
2. Procedures for declaring eligibility for purchase and sale:
a) Before purchasing and selling medical equipment of types B, C, D, the head of the medical equipment purchasing and selling facility is responsible for submitting a dossier declaring eligibility for purchasing and selling as prescribed in Clause 1 of this Article to the Department of Health where the purchasing and selling facility is located;
b) Upon receiving the dossier, the Department of Health shall issue to the facility a Receipt of dossier for declaration of eligibility for trading according to Form No. 05 specified in Appendix IV issued with this Decree;
c) Within 03 working days from the date of receiving the dossier declaring eligibility to buy and sell, the Department of Health is responsible for publicizing the following information on the electronic information portal: name and address of the medical equipment trading facility; dossier declaring eligibility to buy and sell medical equipment.
3. Facilities are only allowed to buy and sell medical equipment of types B, C, D after completing the procedures to declare eligibility to buy and sell as prescribed in Clause 2 of this Article, except for the cases prescribed in Article 39 of this Decree.
4. Adjust information in the declaration of eligibility to buy and sell medical equipment:
a) Cases where information in the declaration of eligibility to purchase and sell medical equipment is adjusted:
– Change of technical staff of the trading facility;
– Change administrative information about address and contact phone number.
b) Application for adjusting information in the declaration of eligibility to purchase and sell medical equipment:
– A written request for adjustment with the stamp of the trading establishment according to Form No. 21 specified in Appendix I issued with this Decree, which must clearly state the content of the change;
– In case of change of technical staff: Personnel declaration according to the form prescribed in Appendix II issued with this Decree, which must clearly state the content of the change;
– In case of change of administrative information: Documents proving change of address and phone number of the trading establishment.
c) Adjustment procedure:
– After receiving the application for adjustment of information in the dossier declaring eligibility to purchase and sell medical equipment, the Department of Health shall issue to the facility a Receipt of adjustment of dossier declaring eligibility to purchase and sell medical equipment according to Form No. 15 specified in Appendix IV issued with this Decree;
– Within 03 working days from the date recorded on the Receipt of Adjustment of the dossier for declaration of eligibility to purchase and sell medical equipment, the Department of Health is responsible for updating the changed information on the electronic information portal. In case of non-acceptance, a written response must be provided stating the reasons.
5. During the operation, the trading establishment must re-conduct the procedure for declaring eligibility for trading if there is any change related to the previously declared dossier that does not fall under the case specified in Point a, Clause 4 of this Article.
Article 39. Buying and selling medical equipment without having to meet the conditions and without having to carry out procedures to declare eligibility for buying and selling
1. Medical equipment of types B, C, D in the list of medical equipment issued by the Minister of Health are bought and sold like normal goods.
2. The purchase and sale of medical equipment as prescribed in Clause 1 of this Article does not have to satisfy the conditions prescribed in Article 37 of this Decree and does not have to carry out the procedures for declaring eligibility for purchase and sale as prescribed in Article 38 of this Decree, but must still satisfy the conditions for preservation, storage and transportation as prescribed by the owner of the medical equipment.
Section 2. EXPORT AND IMPORT OF MEDICAL EQUIPMENT
Article 40. Principles of management of export and import of medical equipment
1. Organizations and individuals exporting and importing medical equipment must meet the conditions prescribed by law on export, import and
must be responsible for ensuring the quality of medical equipment that they export and import.
2.43 Medical equipment with circulation number in Vietnam is allowed to be exported and imported.
Imported according to demand, without quantity limit and without approval from the Ministry of Health, except for medical equipment containing narcotic substances and precursors.
3. The issuance of a certificate of free circulation only applies to exported medical equipment according to regulations of the Prime Minister.
4. Temporary import for re-export, temporary export for re-import, or transfer or transit of medical equipment shall comply with the provisions of law.
5. The import of used medical equipment is carried out in accordance with the provisions of the law on commerce.
Article 41. Export and import of medical equipment
1. Encourage domestic enterprises to produce for export.
2.44 Organizations and individuals importing medical equipment with circulation numbers must meet the following conditions:
a) Be the owner of the circulation number or have a power of attorney from the owner of the circulation number. When authorizing an importing facility to import medical equipment, the owner of the circulation number must simultaneously send that power of attorney to the authority issuing the circulation number and the customs authority;
b) Have warehouses and means of transport that meet the requirements prescribed in Clause 2, Article 37 of this Decree or have a contract with a facility with sufficient capacity to store and transport medical equipment;
c) Have a warehouse and a system to monitor and manage the export, import, and inventory of medical equipment containing narcotic substances and precursors that meet the requirements specified in Clause 3, Article 37 of this Decree.
3. The procedures for exporting and importing medical equipment shall comply with the provisions of the law on customs. Organizations importing medical equipment shall not be required to prove that they meet the conditions prescribed in Clause 2 of this Article when carrying out customs procedures.
Article 42. Export and import licenses45
1. Cases requiring an import license:
a) Medical equipment without a circulation number imported to serve scientific research or inspection or training on the use and repair of medical equipment;
b) Medical equipment without a circulation number imported for aid and humanitarian aid purposes;
c) Medical equipment without a circulation number imported to serve humanitarian medical examination and treatment activities;
d) Medical equipment without a circulation number imported for personal medical use includes medical equipment manufactured according to specific instructions for personal use or according to special diagnostic needs of medical facilities;
d) Medical equipment containing narcotic substances and precursors with circulation registration numbers, raw materials for manufacturing medical equipment that are narcotic substances and precursors;
e) Medical equipment containing narcotic substances and precursors imported for scientific research or testing purposes;
g) Used medical equipment imported for research and training purposes (not for human use and not for diagnostic or treatment purposes). The import of medical equipment in this case is carried out in accordance with the regulations of the Prime Minister;
h) Raw materials for manufacturing medical equipment are imported narcotics and precursors for research or testing purposes.
2. Cases requiring an export license:
a) Medical equipment containing narcotic substances and precursors;
b) Raw materials for the production of medical equipment are narcotics and precursors.
3. Import license application includes:
a) Application for import license according to Form No. 08 specified in Appendix I issued with this Decree;
b) Documents summarizing the technical description of medical equipment in Vietnamese according to Form No. 01 specified in Appendix VIII issued with this Decree;
c) Certificate of quality management standards of the medical equipment manufacturing facility with confirmation from the organization or individual requesting the import license;
d) In case of import for research purposes, there must be an additional certified copy of the decision approving the research topic and documents proving that the medical equipment proposed for import has been permitted for circulation by a competent authority, with confirmation from the organization or individual requesting the import license;
d) In case of import for training purposes, there must be an original copy of the training program and documents proving that the medical equipment proposed for import has been permitted for circulation by a competent authority, with confirmation from the organization or individual requesting the import license;
e) For import for inspection purposes: Confirmation document from the inspection unit stating the quantity;
g) In case of import for aid purposes, there must be an additional copy of the decision approving the receipt of aid from the competent authority and documents proving that the medical equipment proposed for import has been permitted for circulation by the competent authority, with confirmation from the organization or individual requesting the import license;
h) For cases of import to serve humanitarian medical examination and treatment activities: documents proving that the medical equipment proposed for import has been permitted for circulation by a competent authority with confirmation from the organization or individual requesting the import license;
i) In case of import for special diagnostic needs of medical facilities, there must be additional documents proving that the medical equipment proposed for import has been permitted for circulation by a competent authority with confirmation from the organization or individual requesting the import license;
k) In case of import for personal medical treatment purposes, there must be an additional copy of the doctor's prescription appropriate to the disease of the individual requesting the import.
4. Application for import of medical equipment containing narcotic substances and precursors:
a) Application for importing medical equipment containing narcotic substances and precursors with circulation registration number:
– A written request for import according to Form No. 13 specified in Appendix I issued with this Decree, which must clearly explain the reasons if the quantity of medical equipment containing narcotic substances and precursors proposed for import exceeds 150% compared to the previous import quantity;
- Report on business results of medical equipment containing narcotic substances and precursors according to Form No. 02 specified in Appendix X issued with this Decree;
b) Application for importing medical equipment containing narcotic substances and precursors for scientific research or testing purposes:
– Import request document according to Form No. 13 specified in Appendix I issued with this Decree;
– Documents specified in points b, c, d, e, Clause 3, Article 42 of this Decree.
5. Application for importing raw materials to produce medical equipment containing narcotic substances and precursors for production:
a) Import request document according to Form No. 14 specified in Appendix I issued with this Decree;
b) A copy of the quality standards and methods for testing the quality of narcotic substances and precursors of the manufacturing facility with the stamp of the importing facility;
c) Certified copy of the Production License of the raw material manufacturing facility issued by the competent management agency of the exporting country. The Production License must be consularly legalized in accordance with the law on consular legalization, except in cases of exemption under the law;
If the documents specified in points b and c of this clause are not presented in Vietnamese or English, a notarized translation of the document into Vietnamese or English must be submitted.
d) Report on the use of raw materials for the production of medical equipment containing narcotic substances and precursors according to Form No. 03 specified in Appendix X issued with this Decree; dd) Report on the business results of raw materials for the production of medical equipment containing narcotic substances and precursors according to Form No. 02 specified in Appendix X issued with this Decree;
e) Production and usage plan for the proposed imported raw materials and expected business plan for finished products manufactured from the proposed imported raw materials.
6. Application for importing raw materials to produce medical equipment containing narcotics and precursors for testing and research:
a) Document requesting the import of raw materials for the production of medical equipment containing narcotic substances and precursors according to Form No. 14 specified in Appendix I issued with this Decree;
b) In case of import for research and production of medical equipment, there must be additional documents certified by the manufacturing facility requesting the import license proving that the research uses raw materials to produce medical equipment containing narcotic substances and precursors;
c) In case of import for inspection purposes, there must be an additional confirmation document from the unit performing the inspection, clearly stating the expected quantity to be used for inspection.
7. Application for export of medical equipment containing narcotic substances and precursors, raw materials for production of medical equipment containing narcotic substances and precursors:
a) Request document according to Form No. 15 or Form No. 16 specified in Appendix I issued with this Decree;
b) Report the quantity and origin of medical equipment and raw materials for manufacturing medical equipment containing narcotic substances and precursors according to Form No. 04 specified in Appendix X issued with this Decree;
c) A valid document permitting the import of medical equipment and raw materials for the production of medical equipment containing narcotic substances and precursors issued by the competent authority of the importing country. In case the import permit is not in Vietnamese or English, a notarized translation of the license into Vietnamese or English must be submitted. The import permit must be consularly legalized in accordance with the law on consular legalization, except in cases of exemption under the law.
8. Procedures for considering requests for licenses to import and export medical equipment and raw materials for manufacturing medical equipment containing narcotic substances and precursors:
a) After receiving the application for a license to import or export medical equipment and raw materials for manufacturing medical equipment containing narcotic substances and precursors, the Ministry of Health shall send the organization or individual a Receipt of Application according to Form No. 06 specified in Appendix IV issued with this Decree;
b) In case there is no request to amend or supplement the application for a license to import or export medical equipment or raw materials for the production of medical equipment containing narcotic substances and precursors, the Ministry of Health must conduct an appraisal to grant an import or export license within 15 working days from the date stated on the Application Receipt. In case of refusal, there must be a written reply stating the reason. In case of granting an export license for medical equipment containing narcotic substances or precursors, raw materials containing narcotic substances or precursors, the Ministry of Health must conduct an appraisal to grant an export license within 15 working days from the date of the Ministry of Public Security's pre-export notice. In case of refusal, there must be a written reply stating the reason;
The export and import license is sent to the organization or individual requesting the export or import, and the customs authority. In case of medical equipment or raw materials containing narcotics or precursors, the export and import license is also sent to the Ministry of Public Security and the Ministry of Finance;
Licenses for exporting and importing medical equipment containing narcotic substances and precursors, and raw materials for manufacturing medical equipment containing narcotic substances and precursors are issued for each export or import and are valid for the period stated in the license.
c) In case the application for a license to export or import medical equipment or raw materials for manufacturing medical equipment containing narcotic substances and precursors is invalid, within 05 working days from the date recorded on the Application Receipt, the Ministry of Health must issue a written notice to the organization or individual requesting a license to export or import medical equipment to supplement or amend the application. The written notice must specifically state which documents need to be supplemented and which content needs to be amended.
d) Upon receiving a document requesting to supplement or amend import or export documents, the organization requesting the issuance of an import or export license must supplement or amend according to the contents stated in the document and send it to the Ministry of Health;
In case the organization or individual requesting an import or export license has supplemented or modified the dossier but it does not meet the requirements, the Ministry of Health will notify the organization or individual to continue completing the dossier.
d) After 60 days from the date the Ministry of Health issues a written request, if the organization or individual requesting an import or export license does not supplement or amend the dossier, it must start over.
e) If there are no additional or revised requirements, the Ministry of Health shall be responsible for granting import and export licenses in accordance with the provisions of Point b of this Clause. The import and export license shall be sent to the organization or individual requesting the import or export and the customs authority.
Article 43. Application for a certificate of free circulation for domestically produced medical equipment46
The Ministry of Health only issues free circulation certificates for medical equipment items that have been granted circulation registration numbers.
1. Application for a certificate of free circulation of medical equipment:
a) Document requesting the issuance of a certificate of free circulation according to Form No. 12 specified in Appendix I issued with this Decree;
b) Submit a certified copy of the certificate of quality standards recognized by a conformity assessment organization in accordance with the provisions of law that is still in effect at the time of application submission;
c) Submit the original or a copy of the valid circulation number;
2. Procedures for granting a Certificate of Free Circulation shall be implemented in accordance with the provisions of Decree No. 69/2018/ND-CP dated May 15, 2018 of the Government detailing a number of articles of the Law on Foreign Trade Management.
3. The Certificate of Free Circulation is issued according to Form No. 12 specified in Appendix IV issued with this Decree.
Article 44. Competence and procedures for granting new, re-granting and revoking certificates of free circulation
1. The Minister of Health is responsible for issuing new, re-issuing, and revoking free circulation certificates for medical equipment.
2. Procedures for granting new, re-granting and revoking certificates of free circulation according to the Prime Minister's regulations on granting certificates of free circulation.
Section 3. RIGHTS AND OBLIGATIONS OF ORGANIZATIONS AND INDIVIDUALS PARTICIPATING IN MEDICAL EQUIPMENT PURCHASE AND SALE ACTIVITIES
Article 45. Rights of medical equipment trading establishments
1. Require the medical equipment seller to provide full information, traceability records, and warranty of the medical equipment.
2. Require organizations and individuals importing, distributing, and using products to cooperate in recalling and handling defective medical equipment.
3. Require the owner of the medical equipment circulation number to fulfill the medical equipment warranty obligation.
4. Be notified by the circulation number owner about the defective medical device.
5. Other rights as prescribed by law.
Article 46. Obligations of medical equipment trading establishments
1. Implement internal control measures to maintain the quality of medical equipment as prescribed by the circulation number owner.
2. Provide users with complete and timely information about:
a) Instructions for using medical equipment; conditions to ensure safety, storage, calibration, inspection, maintenance and care of medical equipment;
b) Notification of defective medical equipment.
3. Maintain medical equipment tracking records and trace the origin and recall medical equipment according to the provisions of this Decree.
4. Promptly notify the circulation number owner and the State management agency of cases of defective medical equipment.
5. Comply with legal regulations and inspection and examination decisions of competent state agencies.
6. Other obligations as prescribed by law.
Chapter VI
MEDICAL EQUIPMENT SERVICES
Section 1. TECHNICAL CONSULTATION ON MEDICAL EQUIPMENT
Article 47. Conditions for providing consulting services on medical equipment technology
1. The provision of consulting services on cataloging and building configurations and technical features of medical equipment must be performed by individuals who have been certified to have received training in medical equipment technical consulting.
2. Conditions for individuals providing technical consulting on medical equipment:
a) Have a university degree in engineering, medicine or pharmacy or higher;
b) Have at least 05 years of direct working experience in medical equipment engineering at a medical equipment facility;
c) Has been tested and recognized by a training facility as having the ability to provide technical advice on medical equipment according to the training program issued by the Ministry of Health.
3. Consultants are only allowed to provide advice on medical equipment technology after the Ministry of Health has issued a receipt for the dossier declaring eligibility to provide advice on medical equipment technology as prescribed in Point b, Clause 2, Article 48 of this Decree.
Article 48. Dossier and procedures for declaring eligibility for consulting on medical equipment technology
1. The dossier for declaring eligibility for consulting on medical equipment technology includes:
a) Document requesting to declare eligibility for consultancy according to form No. 09 specified in Appendix I issued with this Decree;
b) Certified copies of diplomas and certificates as prescribed in Point a and Point c, Clause 2, Article 47 of this Decree;
c) Confirmation of working time according to the form prescribed in Appendix III issued with this Decree.
2. Procedures for declaring eligibility for consulting on medical equipment technology:
a) Before providing consultation on medical equipment technology, the person requesting to declare eligibility to provide consultation on medical equipment technology is responsible for submitting the documents specified in Clause 1 of this Article to the Ministry of Health;
b) Upon receiving a complete and valid dossier, the Ministry of Health shall issue to the person performing the announcement a dossier receipt form according to form No. 07 specified in Appendix IV issued with this Decree;
c) Within 03 working days from the date recorded on the Dossier Receipt Form, the Ministry of Health is responsible for publicizing the following information on the Ministry of Health's electronic information portal: name, address, contact phone number of the consultant; scope of consultation on medical equipment technology and dossier declaring eligibility for medical equipment technology consultation.
3. During the operation, the consultant must re-conduct the procedure of declaring eligibility for consulting if there is any change related to the previously declared profile.
Section 2. INSPECTION AND CALIBRATION OF MEDICAL EQUIPMENT47
Article 49. Principles of inspection and calibration of medical equipment
1. Medical equipment on the list announced by the Minister of Health must be inspected for safety and technical features before being put into use (except for the cases specified in Article 51 of this Decree), periodically, and after major repairs. Inspection of medical equipment that is measuring equipment and radiation equipment shall be carried out in accordance with the provisions of Clause 2 of this Article.
2. Medical equipment that is a measuring instrument or radiation device must be inspected and calibrated according to the provisions of law on measurement and atomic energy.
Article 50. Conditions for business of medical equipment inspection services
Conditions on facilities and personnel; application documents for issuance of Certificates; form of application submission; procedures for issuance of new, additional, re-issuance and revocation of Certificates of registration for medical equipment inspection activities are implemented according to current regulations of law on business conditions for conformity assessment services;
In particular, meeting professional requirements for the field of medical equipment inspection is regulated as follows: each inspection process that the inspection organization registers to perform must have at least 02 inspectors with certificates of training in that inspection process.
Article 51. Exemption from initial inspection before putting into use for medical equipment
Medical equipment is exempted from initial inspection before being put into use if it falls into one of the following cases:
1. Medical equipment has been certified;
2. Medical equipment without a circulation number imported for the purpose of scientific research or for training in the use, maintenance and repair of medical equipment;
3. Medical equipment without a circulation number imported for use for the importer's personal medical treatment purposes or for humanitarian medical examination and treatment purposes or for special diagnostic needs;
4. Medical equipment without circulation number imported to serve fairs, exhibitions, displays and product introductions.
Article 52. Handling of medical equipment that fails inspection requirements
1. In case the medical equipment has unsatisfactory inspection results before being put into use:
a) Medical facilities are not allowed to receive or use medical equipment;
b) The inspection organization sends a written notice of unsatisfactory inspection results to the Ministry of Health;
c) In case there are 03 medical devices in the same batch with unsatisfactory inspection results in terms of safety and functionality, the Ministry of Health shall issue a document requesting the owners of the circulation registration number to report the quantity of medical devices currently circulating on the market and being used at medical facilities;
Based on the owner's report and the unsatisfactory inspection results, the Ministry of Health decides on re-inspection, the number of samples to be re-inspected or suspends the use of medical equipment;
Based on the re-inspection results, the Ministry of Health will decide to continue re-inspection, supplement the number of samples that must be re-inspected, or request the owners of the circulation registration numbers to recall all medical equipment in that batch;
In case 03 batches of medical equipment are recalled within the validity period of the circulation number, the circulation registration number for that medical equipment shall be revoked. Medical equipment that has been used at medical facilities before the decision to revoke the circulation number shall continue to be used if the inspection results meet the requirements.
2. In case the medical equipment has failed periodic inspection or major repair inspection results:
a) Medical facilities are not allowed to continue using medical equipment;
b) Remove the old inspection status sign;
c) Coordinate with the circulation number owner in taking corrective measures and re-inspecting.
d) Equipment may only be used when the inspection results meet requirements.
Chapter VII
MEDICAL EQUIPMENT INFORMATION AND LABELS
Article 53. Information on medical equipment
1. Information on medical equipment is intended to guide the rational and safe use of medical equipment for medical staff and users of medical equipment.
2. Information on medical equipment must be complete, objective, accurate, honest, easy to understand and not misleading.
3. Responsibility for information on medical equipment is regulated as follows:
a) The owner of the circulation number and the medical equipment trading establishment are responsible for publicly disclosing information on the risk level and information related to the use of medical equipment;
b) Medical facilities are responsible for disseminating information about medical equipment within the facility;
c) Medical staff are responsible for informing patients about the risk level of using medical equipment of type C and D;
d) The medical equipment management agency is responsible for publicizing information about medical equipment.
4. Organizations and individuals providing information about medical equipment must be responsible for the information they provide.
5. The Minister of Health is responsible for organizing the information system on medical equipment.
Article 54. Medical equipment labels
1.48 Labeling of medical equipment is carried out in accordance with current regulations of law on product labeling.
2. Medical equipment imported into Vietnam whose labels do not show or do not fully show the contents as prescribed in Clause 1 of this Article must have a supplementary label showing the required contents in Vietnamese and keep the original label of the goods.
Chapter VIII
MANAGEMENT AND USE OF MEDICAL EQUIPMENT AT MEDICAL FACILITIES
Article 55. Principles of management and use of medical equipment
1. The management and use of medical equipment must be in accordance with its purpose, function, and regime, ensuring savings and efficiency.
2.49 Medical equipment must be stored, preserved, maintained, used and comply with other technical instructions as prescribed by the manufacturer and must be inspected as prescribed in this Decree to ensure quality.
For medical equipment with strict requirements on occupational safety and hygiene, in addition to complying with the regulations on quality assurance as prescribed in this Decree, it must also comply with the provisions of the law on occupational safety and hygiene.
3. Must establish, manage and store complete records of medical equipment; promptly and fully account for medical equipment in kind and value according to current regulations of law on accounting, statistics and other relevant legal regulations; ensure funding to perform tasks as prescribed in Clause 2 of this Article.
4. Subject to inspection, examination and supervision by competent management agencies on medical equipment management.
Article 56. Management and use of medical equipment in State medical facilities50
In addition to managing and using medical equipment as prescribed in Article 55 of this Decree, State medical facilities must manage medical equipment according to the following regulations:
1. Investment, purchase, management and use of medical equipment must comply with the provisions of law on management and use of public assets.
2. Encourage the use of domestically produced medical equipment.
Article 57. Rights and responsibilities of medical facilities in managing and using medical equipment
1. Medical facilities have the following rights:
a) Require the circulation number owner to perform periodic maintenance during the warranty period;
b) Require the seller to provide technical documents of medical equipment;
c) Receiving used medical equipment for scientific research purposes and providing instructions on the use and repair of medical equipment.
2. Medical facilities are responsible for:
a) Use and operate medical equipment in accordance with the instructions of the owner of the medical equipment;
b) Periodically maintain, inspect and calibrate according to the instructions of the owner of the medical equipment or regulations of law;
c) Participate in testing and evaluating the quality of medical equipment;
d) Report on cases of defective medical equipment and other information as required by competent state agencies;
d)51 Medical facilities must check quality management records when receiving medical equipment; keep and update test results of all batches of medical gases.
Chapter IX
ANNOUNCEMENT, ONLINE REGISTRATION
Article 58. Cases of online announcement, registration and licensing request
1. Announcement of eligibility for medical equipment classification.
2. Announcement of eligibility to manufacture medical equipment.
3. Announcement of standards applicable to medical equipment.
4. Registration of medical equipment circulation.
5. Announcement of eligibility to buy and sell medical equipment.
6. Announcement of eligibility for consulting on medical equipment technology.
7.52 Request for certificate of registration for medical equipment inspection activities.
8. Request for license to import medical equipment.
9. Request for free circulation certificate for domestically produced medical equipment.
10.53 Issuance of certificates of practice in medical equipment classification.
Article 59. Requirements for online declaration, registration and licensing application dossiers
Online dossiers of declaration, registration, license application, and free circulation certificate application (hereinafter referred to as registration dossiers) are considered valid when fully ensuring the following requirements:
1. All documents and their contents must be fully declared as prescribed in paper documents and converted to electronic documents. The name of the electronic document must correspond to the name of the document type in the paper documents.
2. Information on announcement, registration and license request must be entered fully and accurately according to the information in the electronic documents.
Article 60. Online announcement procedures
1. The legal representative declares information, downloads electronic documents, confirms with a public digital signature and pays the fee online according to the process on the electronic information portal of the Ministry of Health or the Department of Health.
2. After completing the online application submission, the legal representative will receive an Online Application Receipt.
3. The agency receiving online registration dossiers shall carry out administrative procedures corresponding to the registration dossiers as prescribed in this Decree.
4. The result of an online administrative procedure is an electronic document with a digital signature of the agency receiving the application and has the same legal value as the result of an administrative procedure resolved by the usual method.
5.54 During the operation, the owner of the circulation number shall keep the previously announced receipt number in the cases of change in Clause 4, Article 24 of this Decree.
Article 61. Storage of online registration records
1.55 In case of online registration, the registration authority must store the registration records as prescribed in Clause 1, Article 30 of this Decree.
2. In case the documents in the registration dossier specified in Clause 1 of this Article are lost or damaged, the registration agency shall be responsible for notifying in writing the dossier receiving agency, completing the dossier and notifying in writing the dossier receiving agency after completing the dossier, and updating the dossier after obtaining the consent of the dossier receiving agency.
3. Within 35 days from the date of receipt of notice of loss of records, if the facility does not have a written notice that the records have been completed, the agency receiving the records shall be responsible for:
a) Cancel the information posted on the electronic portal related to the facility performing the classification of medical equipment, the facility manufacturing medical equipment, the facility buying and selling medical equipment, the medical equipment technical consultant, the facility inspecting and calibrating medical equipment, and the circulation number of the equipment;
b) Revoke the circulation number and import license of medical equipment.
4. The registered facility shall not continue to operate and the medical equipment shall not be circulated from the time the dossier receiving agency cancels the information as prescribed in Clause 3 of this Article.
Chapter X
IMPLEMENTATION ORGANIZATION
Article 62. Responsibilities of the Ministry of Health
The Ministry of Health is responsible to the Government for performing state management of medical equipment and has the following duties and powers:
1. Submit to the Government and the Prime Minister for promulgation or promulgate under its authority legal documents, national technical regulations, strategies, policies, and plans on medical equipment, including:
2. Directing and organizing the implementation of legal documents, strategies, policies and plans on medical equipment.
3. Organize information and communication about medical equipment.
4. Organize training and development of human resources for medical equipment work.
5. Publicly post on the Ministry of Health's electronic information portal information about:
a) Winning bid price for purchasing medical equipment of State medical facilities nationwide;
b) List of medical equipment whose circulation numbers have been revoked.
6. Inspect, examine, resolve complaints, denunciations and handle violations of the law in the field of medical equipment.
7. International cooperation on medical equipment.
8.56 Detailed regulations on the classification of medical equipment ensure compliance with international treaties on the classification of medical equipment of the Association of Southeast Asian Nations of which Vietnam is a member; promulgate a training program on practical classification of medical equipment.
9.57 Issue a list of medical equipment that must be inspected and the inspection process for each type of medical equipment in the list.
10.58 Specific guidance on how to record in the ASEAN common technical dossier.
Article 63. Responsibilities of the Ministry of Science and Technology
1. Issue a list of medical equipment that are measuring instruments that must have their models approved, inspected, and calibrated after receiving consensus from the Ministry of Health.
2. Preside over or coordinate with the Ministry of Health in developing national standards on medical equipment; inspect and examine the quality of medical equipment such as measuring instruments and radiation equipment.
Article 64. Responsibilities of the Ministry of Finance
1. Guidance on the management of public assets as medical equipment for State medical facilities after receiving opinions from the Ministry of Health.
2. Specify the management and use of fees and charges in the field of medical equipment according to the provisions of law on fees and charges.
Article 65. Responsibilities of the Provincial People's Committee
1. Responsible for managing activities related to business and use of medical equipment in the province.
2. Organize information and communication about medical equipment in the province.
3. Organize training for human resources working in medical equipment in the province.
4. Publicly post on the electronic information portal of the Provincial People's Committee and send to the Ministry of Health information about:
a) Winning bid price for purchasing medical equipment of State medical facilities in the province;
b) List of medical equipment whose circulation numbers have been revoked in the province.
5. Inspect, examine, resolve complaints, denunciations and handle violations of the law in the field of medical equipment in the province.
Article 66. Responsibilities of organizations and individuals trading in medical equipment
1. Organizations and individuals trading in medical equipment must be responsible for the safety and quality of the medical equipment they trade.
2.59 The owner of the circulation number is responsible for:
a) Implement the announcement of applicable standards or registration of circulation of medical equipment according to the provisions of this Decree;
b) Establish and maintain a medical equipment warranty facility or sign a contract with a medical equipment warranty facility;
c) Establish and maintain medical equipment tracking records and trace the origin of medical equipment according to the provisions of this Decree, except for single-use medical equipment as prescribed by the medical equipment owner; report to the Department of Health and the Police when detecting mistakes or losses of medical equipment containing narcotics and precursors, or raw materials for manufacturing medical equipment containing narcotics and precursors;
d) Full and accurate information about the product on the label and in the documents accompanying the medical equipment according to the provisions of law on product labels and the provisions of this Decree;
d) Timely, complete and accurate warnings about risks of adverse effects on users' health and the environment; prevention methods for sellers and consumers; providing information on requirements for transportation, storage, preservation and use of medical equipment;
e) Promptly stop circulation, notify relevant parties and take measures to handle, fix or recall defective medical equipment according to the provisions of this Decree. In case of disposal by destruction, the destruction of medical equipment must comply with the provisions of the law on environmental protection, the provisions of relevant laws and must bear all costs for such destruction;
g) Comply with legal regulations and inspection and examination decisions of competent state agencies;
h) Compensate for damages according to the provisions of law when medical equipment is defective;
i) Responsible for ensuring that the following documents remain valid during the period the circulation number is valid:
– Certificate of free circulation for imported medical equipment;
– Power of attorney except in the case specified in Point a, Clause 1, Article 21 of this Decree;
– Warranty eligibility certificate or proof of warranty exclusion if not applicable.
k) Responsible for ensuring that medical equipment is only manufactured during the period when the quality management standard certificate of the manufacturing facility is still valid;
l) Be responsible before the law for the legality and accuracy of posted documents when performing procedures in this Decree;
m) Provide the medical facility where the medical equipment is purchased with 01 set of quality management records specified in Clause 4, Article 30 of this Decree for that medical equipment;
n) Other obligations as prescribed by law.
3. The representative office of the circulation number owner must fully perform the obligations prescribed in Clause 2 of this Article.
4.60 Establishments that purchase, sell, export, import, and transfer medical equipment containing narcotic substances and precursors, and raw materials for the production of medical equipment containing narcotic substances and precursors are responsible for:
a) Report on the purchase, sale, export, import and transfer of medical equipment containing narcotics and precursors, raw materials for the production of medical equipment that are narcotics and precursors according to Forms No. 05 and 06 specified in Appendix X issued with this Decree to the Ministry of Health and the Ministry of Public Security for the export and import of medical equipment containing narcotics and precursors, raw materials for the production of medical equipment that are narcotics and precursors within 10 days from the date of purchase, sale, export, import and transfer of medical equipment or raw materials for the production of medical equipment that contain narcotics and precursors;
b) Six-month and annual reports on the export, import, inventory and use of medical equipment containing narcotic substances and precursors, and raw materials containing narcotic substances and precursors according to Form No. 03 specified in Appendix X issued with this Decree and sent to the Ministry of Health before July 15 and before January 15 every year;
c) Report to the Department of Health according to Form No. 07 specified in Appendix X issued with this Decree within 48 hours from the time of discovering mistakes or loss of medical equipment containing narcotic substances and precursors, and raw materials that are narcotic substances and precursors.
5.61 Organization of medical equipment classification:
a) During the operation, the Organization performing the classification of medical equipment must be responsible for fully meeting the conditions specified in Article 7 of this Decree;
b) Be responsible and take remedial measures for cases of issuing incorrect classification results on the risk level of medical equipment or issuing incorrect classification results on the authority prescribed in this Decree;
c) Announce the classification results on the Ministry of Health's electronic information portal within 05 working days from the date of issuance.
6.62 Medical equipment manufacturing facilities are allowed to import active ingredients with pharmacological effects to manufacture medical equipment. Facilities are only allowed to use imported active ingredients to manufacture medical equipment, not for other purposes, except in cases where they are sold to other medical equipment manufacturing facilities to manufacture the same product. Documents and procedures for importing active ingredients with pharmacological effects to manufacture medical equipment are carried out in accordance with the provisions of the law on pharmaceuticals.
Chapter XI
IMPLEMENTATION PROVISIONS63
Article 67. Entry into force
1. This Decree comes into force from the date of signing and promulgation.
2. Clause 10, Article 12 of Decree No. 89/2006/ND-CP dated August 30, 2006 of the Government on product labels ceases to be effective from the effective date of this Decree.
Article 68. Transitional provisions
1. Medical equipment manufacturing facilities that have been operating before the effective date of this Decree may continue manufacturing activities but must complete the declaration of eligibility for manufacturing before July 1, 2017. Particularly for the provisions on quality management systems: Medical equipment manufacturing facilities must complete the application of the ISO 9001 quality management system before January 1, 2018 and the ISO 13485 quality management system before January 1, 2020.
2. Trading establishments that have been operating before the effective date of this Decree may continue to operate but must complete the procedures for declaring eligibility for trading as prescribed in this Decree before January 1, 2017.
3. Organizations and individuals providing medical equipment services that have been operating before the effective date of this Decree may continue to operate but must complete the request for declaration of eligibility for medical equipment technical consultancy or declaration of eligibility for inspection and issuance of practice certificates before July 1, 2017.
4. Medical equipment that has been manufactured in Vietnam or imported into Vietnam before the effective date of this Decree shall continue to be circulated until it is liquidated according to the provisions of Clause 1, Article 22 of the Law on Management and Use of State Assets or until the expiry date stated on the certificate of registration for circulation.
5.64 The granting of licenses to import medical equipment or the issuance of circulation registration numbers for domestically produced medical equipment or medical equipment that is in vitro diagnostic biological products shall be carried out in accordance with current laws until the expiration of the period specified in Clause 6 of this Article and shall be valid as follows:
a) For import licenses for medical equipment of types B, C, D and import licenses for in vitro diagnostic biological products issued in 2018, 2019, 2020, 2021, the issued import licenses are valid until December 31, 2021 and the Customs authority shall not control the import quantity in this case, except for the case specified in Clause 1, Article 42 and Point d of this Clause.
Organizations and individuals trading in medical equipment are responsible for ensuring that the documents specified in Point i, Clause 2, Article 66 of this Decree are always valid during the validity period of the import license. In case of not continuing to maintain the validity of the above documents, organizations and individuals trading in medical equipment must be responsible for notifying the Ministry of Health to revoke the issued import license according to regulations.
b) For medical equipment of type A with a receipt of application for declaration of applicable standards issued by the Department of Health, it can be imported according to demand, without quantity restrictions, without requiring a classification and a document confirming that it is medical equipment from the Ministry of Health when carrying out customs clearance procedures;
Medical equipment that is not on the list requiring an import license and has been classified as medical equipment of type B, C, D by a classification organization published by the Ministry of Health on the electronic information portal may continue to be imported until December 31, 2021 according to demand, without quantity restrictions, without requiring a document confirming that it is medical equipment from the Ministry of Health when carrying out customs clearance procedures.
c) For medical equipment that is an in vitro diagnostic biological product that has been granted a circulation registration certificate in accordance with the provisions of the 2005 Pharmacy Law and documents guiding the implementation of this Law, the circulation number granted is valid until the end of the period stated on the circulation registration certificate. Particularly for circulation registration numbers for in vitro diagnostic biological products that expire after January 1, 2019 and before December 31, 2021, the circulation number granted is valid until December 31, 2021;
Medical equipment that is an in vitro diagnostic biological product that has submitted a registration application for circulation according to the provisions of the 2005 Pharmacy Law before January 1, 2019 shall be resolved according to the provisions of the 2005 Pharmacy Law;
Medical equipment that is an in vitro diagnostic biological product imported and submitted during the period from January 1, 2019 to December 31, 2021 will be granted an import license according to the provisions of the 2005 Pharmacy Law and will be valid until December 31, 2021;
Start receiving applications and issuing registration numbers for domestically produced medical equipment from January 1, 2019. Registration numbers are effective from the date of issue.
d) Chemicals, insecticides, and disinfectants used in the household and medical fields with the sole purpose of disinfecting medical equipment that have been granted a circulation certificate and expire after July 1, 2016 and before December 31, 2020, shall continue to use that circulation certificate until December 31, 2020;
Start receiving applications and issuing registration numbers for chemicals and insecticides and disinfectants used in the household and medical fields with the sole purpose of disinfecting medical equipment from January 1, 2019. Registration numbers are effective from the date of issue.
d) For domestically produced medical equipment that has been granted a certificate of registration for circulation, the circulation number is valid until the end of the period stated on the certificate of registration for circulation. For certificates of registration for circulation that expire after July 1, 2016 and before December 31, 2020, the certificate of registration for circulation will continue to be valid until December 31, 2020.
6.65 Start receiving dossiers declaring applicable standards for medical equipment of type A from January 1, 2017 and the receipt of dossiers declaring applicable standards will be effective from July 1, 2017; start receiving dossiers registering circulation for medical equipment of types B, C, D from July 1, 2017 and the medical equipment circulation number will be effective from January 1, 2022, except for the cases specified in Points c and d, Clause 5 of this Article.
7. Labels of medical equipment manufactured in Vietnam or imported into Vietnam before the date specified in Clause 5 of this Article shall continue to be used until the expiry date of the equipment or until it is liquidated according to the provisions in Clause 1, Article 22 of the Law on Management and Use of State Assets or until the expiry date stated on the certificate of registration for circulation.
8.66 The organization implementing the classification of medical equipment is responsible for completing the public disclosure of the results of the classification of medical equipment issued before December 31, 2018 on the electronic information portal of the Ministry of Health before April 1, 2019.
Documents proving the classification results in the form of acknowledgment submitted to the management agency before December 31, 2018 shall continue to be used to register the circulation of medical equipment for that dossier.
9.67 All certificates of training in medical device classification issued before December 31, 2018 are only valid for 03 years from the date of signing.
10.68 The owner of the circulation number must review the results of medical equipment classification according to the provisions of Clause 2, Article 4 of this Decree and report to the Ministry of Health before July 1, 2019.
In case the review results show a change in the risk level, the owner of the circulation number is responsible for re-registering for circulation according to the new risk level. Imported medical equipment that has been cleared through customs and domestically produced medical equipment that has been shipped before December 31, 2020, which falls under the provisions of this clause, are allowed to circulate until the end of the product's useful life.
11.69 The ASEAN Common Technical Dossier (CSDT) shall be applied from January 1, 2022. From January 1, 2022, establishments requesting the issuance of a circulation number shall not be required to provide the documents specified in Points g, i, m, Clause 1, Article 26 of this Decree.
12.70 Medical gas production facilities must complete the application of the ISO 9001 quality management system or equivalent from January 1, 2020. The Minister of Health shall specify the management of medical gas quality.
13.71 Materials, software, accessories and medical gases are not required to register for circulation or obtain import licenses according to the provisions of this Decree.
Article 69. Responsibility for guidance and implementation
1. The Minister of Health is responsible for guiding, organizing and inspecting the implementation of this Decree.
2. Ministers, Heads of ministerial-level agencies, Heads of Government agencies, Chairmen of People's Committees of provinces and centrally run cities and relevant agencies, organizations and individuals are responsible for implementing this Decree./.