Decree 98/2021/ND-CP on medical equipment management

View and download the Decree here: Decree No. 98/2021/ND-CP on medical equipment management

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GOVERNMENT _________ Number: 98/2021/ND-CP

SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness _______________________ Hanoi, November 8, 2021

 

 DECREE

On medical equipment management

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Pursuant to the Law on Organization of the Government dated June 19, 2015; Law amending and supplementing a number of articles of the Law on Organization of the Government and the Law on Organization of Local Government dated November 22, 2019;

Pursuant to the Investment Law dated June 17, 2020;

At the request of the Minister of Health;

The Government issued a Decree on medical equipment management.

 

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Decree regulates the management of medical equipment, including: classification of medical equipment; production, clinical research, circulation, purchase, sale, export, import, and provision of medical equipment services; information and advertising of medical equipment; management of medical equipment prices and management and use of medical equipment at medical facilities.

2. This Decree does not apply to:

a) Raw materials and semi-finished products for the production of medical equipment, except for raw materials containing narcotic substances and precursors;

b) Raw materials for the production of medical equipment such as blood samples, serum, plasma, urine, feces, human body secretions, and other human samples must ensure biosafety when imported or exported according to the provisions of law;

c) Medical gases;

d) Accessories used with medical equipment;

d) Products used in medicine for research purposes (Research Use Only – RUO), products used in laboratories (Laboratory Use Only – LUO).

Thing 2. Word explanation

1. Medical equipment is equipment, implants, tools, materials, 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;

– 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 devices include reagents, calibrators, control materials, instruments, machines, equipment or systems and other products participating in or supporting the testing process used separately or in combination as directed by the owner to serve the examination of specimens originating from the human body.

3. Personal medical equipment is medical equipment specially manufactured under the prescription of a doctor, with unique design features for use only by a specific individual.

4. 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.

5. The owner of medical equipment (Product owner) includes organizations and individuals who:

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 standards announced by organizations and individuals for application 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.

6. Chemicals and preparations whose sole purpose is to disinfect medical equipment are managed according to the provisions of this Decree. Chemicals and preparations whose purpose is to disinfect 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 sectors.

7. Medical equipment, raw materials for manufacturing medical equipment and externally controlled substances containing narcotics and precursors must be managed for import and export in accordance with the provisions of the law on drug prevention and control and managed in accordance with the provisions of this Decree.

8. The provisions on classification, circulation numbering, and declaration of eligibility for purchase and sale of this Decree shall not apply to:

a) Software used for medical equipment;

b) Medical equipment is bought and sold as normal imported goods in the form of gifts or presents to individuals or organizations that are not medical facilities.

 

Chapter II

CLASSIFICATION OF MEDICAL EQUIPMENT

Article 4. Types of medical equipment

1. Medical devices are classified into four categories based on the level of potential risk associated with the engineering design and manufacture of such medical devices:

2. Class A medical devices are medical devices with low risk levels.

3. Type B medical equipment is medical equipment with a low-medium risk level.

4. Type C medical equipment is medical equipment with a medium-high risk level.

5. Class D medical devices are high-risk medical devices.

Article 5. Principles of medical equipment classification

1. Classification of medical devices must be based on classification rules on risk levels.

2. Where a medical device has only one intended use but that intended use can be classified into two or more different risk levels, the classification according to the highest risk level shall apply.

3. Medical devices have multiple uses and each use has a different level of risk, so the classification according to the highest level of risk is applied.

4. Where a medical device is intended to be used in combination with another medical device, each medical device must be classified separately according to its risk level.

In the case of in vitro diagnostic medical devices, which are devices, equipment systems that participate in the testing process and reagents, controls, standards, calibration materials, and control materials are classified by separate risk levels, but the classification results must be based on the highest risk level of the end-use purpose of the entire combined medical device. In vitro diagnostic medical devices are other products that participate in or support the testing process and are classified by separate risk levels.

5. 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.

6. Classification of medical equipment must be performed by a classification facility that is the facility that announces the applicable standards or registers for circulation.

Article 6. Withdrawal of medical equipment classification results

1. Cases of recalling medical equipment classification results:

a) Misclassification results in a reduction in the risk level of the medical device;

b) The classification results were falsified.

2. Withdrawal procedure:

a) Within 01 working day from the date of conclusion that the classification result falls into one of the cases specified in Clause 1 of this Article, the Ministry of Health shall be responsible for issuing a document to revoke the classification result, requiring 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 revoked medical equipment classification result on the Electronic Portal on Medical Equipment Management.

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 Electronic Information Portal on Medical Equipment Management.

b) 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.

c) After receiving the document revoking the classification results, the agency that receives the application for publication of applicable standards or the application for registration of circulation (hereinafter referred to as the application for issuance of circulation numbers) is responsible for reviewing the circulation numbers it has issued. In case it is discovered that a medical device that has been granted 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 revoke the circulation number for that medical device.

Article 7. Handling of medical equipment using recalled classification results

1. In case the medical equipment is undergoing the procedure to request a circulation number using a revoked classification result:

a) Organizations and individuals submitting applications for circulation numbers are responsible for reporting in writing to the agency receiving applications for circulation numbers to stop the circulation number issuance procedure.

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 revoked classification result 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 the customs clearance procedure; 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 revoked classification result and has gone through customs clearance procedures but has not 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 recalled classification results;

– 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 until the medical equipment is granted a new circulation number according to the adjusted classification results;

- 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-issue 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 a medical device that has been granted a circulation number uses a false classification result but does not potentially affect the patient's health: the medical facility may continue to use that medical device and the owner of the circulation number is responsible for completing the medical device circulation records at the medical facility after receiving a new circulation number.

c) In case a medical device that has been granted a circulation number 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 device 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 8. Conditions on quality management of medical equipment manufacturing facilities

1. Meet ISO 13485 quality management system standards.

2. For establishments manufacturing medical equipment containing narcotic substances and precursors, in addition to meeting the conditions specified in Clause 1 of this Article, the following additional requirements must be met:

a) Have 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, and storing medical equipment, and raw materials containing narcotic substances and precursors;

b) Medical equipment and materials containing narcotic substances and precursors must be stored in a separate area in the warehouse or in a separate warehouse that ensures safety.

Article 9. Dossier for declaration of eligibility to manufacture medical equipment

The dossier declaring eligibility to manufacture medical equipment includes:

1. Document declaring eligibility for production.

2. Certificate of compliance with ISO 13485 quality management standards issued by a conformity assessment organization in accordance with the provisions of law.

3. Documents proving satisfaction of the conditions specified in Clause 2, Article 8 of this Decree.

Article 10. 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 9 of this Decree; there are separations between sections, a cover page and a list of documents.

b) In case the document is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.

2. Requirements for some documents in the dossier for declaring eligibility for production:

a) Original or certified copy or certified copy of the Certificate of Quality Management Standards Compliance issued by the facility requesting the declaration of eligibility for production.

b) Original certified by the facility requesting the declaration of eligibility for production of documents proving satisfaction of the conditions specified in Clause 2, Article 8 of this Decree.

Article 11. Procedures for declaring eligibility to manufacture medical equipment

1. Before manufacturing medical equipment, the medical equipment manufacturing facility is responsible for submitting a declaration dossier to the Department of Health where the manufacturing site is located (the determination of the manufacturing site is based on the location stated in the quality management system certificate). In case there are multiple manufacturing sites in different provinces, the declaration must be made for each province.

2. Upon receiving the dossier (including documents confirming payment of fees as prescribed by the Ministry of Finance), the Department of Health in the locality where the medical equipment manufacturing facility is located shall publicly post on the Electronic Portal on Medical Equipment Management the information and dossier declaring eligibility to manufacture medical equipment.

3. During the operation, the manufacturing facility is responsible for preparing a written notice of the change, along with documents related to the change, and updating those documents in the publicly announced dossier on the Electronic Information Portal on Medical Equipment Management within 03 working days from the date of change in information in the announced dossier.

 

Chapter IV

CLINICAL RESEARCH ON MEDICAL DEVICES

Article 12. Stages of clinical research on medical equipment

1. Phase 1: is the first phase to conduct preliminary research on the safety of medical equipment for humans and the ease of use of medical equipment for doctors and medical staff.

2. Phase 2: is the research phase to determine and demonstrate the safety and effectiveness of medical equipment.

3. Phase 3: is the phase conducted after the medical device has been circulated to continue researching the safety and effectiveness of the medical device after it is widely used in the community under the correct conditions of use.

Article 13. Requirements for medical equipment for clinical research

1. Meet quality standards according to clinical research registration documents.

2. The equipment's technical parameters have been tested and evaluated to ensure quality and safety.

3. The label of medical equipment for clinical research must bear the words "Medical equipment for clinical research use, prohibited for other purposes". Labeling shall comply with the provisions of law on product labeling.

Article 14. Requirements for facilities undertaking clinical research on medical equipment

Facilities undertaking clinical research on medical equipment must meet the following requirements:

1. Is a facility with the function of scientific research, independent of organizations and individuals with medical equipment for clinical research.

2. Have a location, clinical research room, quality management system, and technical documents that meet the principles of Good Clinical Practice according to the guidance of the Minister of Health.

3. Have enough research staff, including:

a) Principal investigators conducting clinical research on medical equipment must have sufficient qualifications and professional capacity in the research field, have experience in clinical practice and use of medical equipment, have a good grasp of regulations on science and technology management and ethics in research, and be able to conduct clinical research on medical equipment;

b) Researchers must have sufficient qualifications and professional capacity appropriate to research requirements, and be trained in knowledge and skills related to clinical research on medical equipment.

Article 15. Clinical research records of medical equipment

The dossier of clinical research on medical equipment includes the dossier requesting approval of clinical research on medical equipment; the dossier requesting approval of changes to clinical research on medical equipment; the dossier requesting approval of clinical research results on medical equipment, which are specifically regulated as follows:

1. The application for approval of clinical research on medical equipment includes:

a) Document requesting approval of clinical research on medical equipment.

b) Information records on clinical research medical equipment include:

– Research product information file (general information about clinical research medical equipment: name, technical specifications, functions and other relevant information);

– Preclinical research documents of medical devices requiring clinical research: research reports on safety, effectiveness, recommendations on usage and storage;

– Documents on clinical research of medical equipment in previous stages (if clinical research of medical equipment is proposed in the next stage and the medical equipment is not exempted from clinical research in previous stages).

c) Legal documents of clinical research medical equipment include:

– Technical documents of medical equipment;

– Technical standards and testing and inspection certificates of medical equipment from competent authorities;

– Licensed instructions for use for medical devices proposed for phase 3 clinical research;

– Document confirming participation of research organizations in multi-center research in Vietnam;

– Contract for cooperation in clinical research of medical equipment between agencies, organizations and individuals with medical equipment for research and medical equipment clinical research service business establishments; cooperation contract between organizations and individuals with medical equipment for clinical research and research support organizations (if any).

d) Clinical research outline of medical equipment and explanatory document including: Clinical research explanatory document of medical equipment and Research information collection form or Research medical record (Case Report Form - CRF).

d) Scientific curriculum vitae and a copy of the certificate of completion of the Good Clinical Practice course on medical equipment of the principal researcher issued by the Ministry of Health or by facilities with the function of training in good clinical practice.

e) Research information sheet and volunteer participation form of participants in clinical research on medical equipment.

g) Minutes of scientific and ethical assessment of research by the basic-level Biomedical Research Ethics Council.

h) Medical equipment labels according to regulations in Clause 3, Article 13 of this Decree and instructions for using research medical equipment.

2. The application for approval of changes to clinical research on medical equipment includes:

a) Document requesting approval of changes to clinical research on medical equipment.

b) The updated versions of the relevant documents specified in Clause 1 of this Article have been changed.

c) Minutes of the review by the Ethics Council in basic-level biomedical research of changes in clinical research on medical equipment that affect the health and rights of participants in medical equipment research or affect the design, process and procedures of the research.

3. The application for approval of clinical research results of medical equipment includes:

a) Document requesting approval of clinical research results of medical equipment;

b) A copy of the approved research proposal;

c) A copy of the Decision approving the approved research proposal;

d) Minutes of assessment of clinical research results on medical equipment by the ethics council in basic-level biomedical research;

d) Full text report of clinical research results on medical equipment.

4. Requirements for documents:

a) Clinical research records of medical equipment must be written in Vietnamese. If they are not in Vietnamese, a notarized translation of the document into Vietnamese must be included;

b) Documents issued by foreign management agencies must be consularly legalized in accordance with the law on consular legalization, except in cases of exemption as prescribed by law.

Article 16. Procedures and order for approval of clinical research on medical equipment

1. The medical equipment clinical research facility shall send directly or by post 01 set of documents requesting approval for medical equipment clinical research to the Ministry of Health.

2. The Ministry of Health shall check the validity of the dossier within 05 working days from the date of receipt of the dossier. In case the dossier is valid, within 02 working days, the Ministry of Health shall forward the dossier to the National Council of Ethics in Biomedical Research (hereinafter referred to as the National Ethics Council) for appraisal. In case the dossier is invalid, there must be a written notice and specific instructions for the facility to supplement the dossier.

The medical device clinical research facility is responsible for completing the dossier within a maximum period of 60 days from the date of receipt of the notification. After this period, the research approval procedure must be re-implemented from the beginning.

3. Within 25 days from the date of receiving a complete and valid dossier, the National Ethics Council shall hold a meeting and have a record of the assessment of the clinical research protocol for medical equipment.

If the assessment meets the requirements, the National Ethics Council will issue a Certificate of Approval of the research proposal.

In case the research proposal is not approved or needs to be revised, the National Ethics Council shall notify the research facility in writing and state the reasons. Within 90 days from the date of receipt of the notification, the medical equipment clinical research facility shall be responsible for completing the dossier and sending it to the National Ethics Council. After this period, the research proposal approval procedure must be re-implemented from the beginning.

Within 07 working days from the date of receiving the complete revised and supplemented dossier, the National Ethics Council must hold a meeting to review. If the requirements are met, the National Ethics Council shall issue a Certificate of approval of the research outline. If the approval is not granted, the National Ethics Council shall notify the clinical research facility in writing and state the reasons.

The profile will only be considered for amendments and supplements a maximum of 03 times.

4. Within 05 working days from the date of receipt of the Certificate of approval of the research outline and accompanying documents, the Ministry of Health shall decide to approve the clinical research outline of medical equipment.

Article 17. Procedures and order for approving changes to clinical research protocols for medical equipment

1. The medical equipment clinical research facility shall send directly or by post 01 set of documents requesting approval of changes to the medical equipment clinical research protocol to the Ministry of Health.

2. The Ministry of Health shall check the validity of the dossier within 05 working days from the date of receipt of the dossier. In case the dossier is invalid, there must be a written notice and specific instructions for the facility to supplement the dossier until the dossier is valid. The facility conducting clinical research on medical equipment is responsible for completing the dossier within a maximum period of 60 days from the date of receipt of the written notice. After this period, the procedure for approving changes to the research outline must be re-implemented from the beginning.

In case the dossier is valid within 02 working days, the Ministry of Health will transfer the dossier to the National Ethics Council for appraisal and have a record of appraisal to change the clinical research protocol of medical equipment.

3. Within 25 days from the date of receiving a complete and valid dossier, the National Ethics Council shall hold a Council meeting and have a record of the review of changes to the clinical research protocol for medical equipment.

In case the assessment meets the requirements, the National Ethics Council will issue a Certificate of Approval for Changes to the Research Outline.

In case the research proposal is not approved or needs to be revised, the National Ethics Council shall notify the research facility in writing and state the reasons. Within 60 days from the date of receipt of the notification, the medical equipment clinical research facility shall be responsible for completing the dossier and sending it to the National Ethics Council. After this period, the procedure for approving changes to the research proposal must be re-implemented from the beginning.

Within 07 working days from receiving the complete revised and supplemented documents, the National Ethics Council will review. If the requirements are met, the National Ethics Council will issue a Certificate of Approval for Changes to the Research Outline. If the request is not approved, the National Ethics Council will notify the clinical research facility in writing and state the reasons.

The profile can only be considered for revision and supplementation a maximum of 03 times.

4. Within 05 working days from the date of receipt of the Certificate of approval for change of research protocol and accompanying documents, the Ministry of Health shall decide to approve the change of clinical research protocol of medical equipment.

Article 18. Procedures and order for approving clinical research results of medical equipment

1. The medical equipment clinical research facility shall send directly or by post 01 set of documents requesting approval of the results of the medical equipment clinical research in Vietnamese to the Ministry of Health.

2. The Ministry of Health shall check the validity of the dossier within 05 working days from the date of receipt of the dossier. In case the dossier is valid, within 02 working days the Ministry of Health shall forward the dossier to the National Ethics Council for appraisal. In case the dossier is invalid, there must be a written notice and specific instructions for the facility to supplement the dossier.

The medical device clinical research facility is responsible for completing the dossier within a maximum period of 60 days from the date of receipt of the notification. After this period, the research results approval procedure must be re-implemented from the beginning.

3. Within 25 days from the date of receiving a complete and valid dossier, the National Ethics Council shall hold a Council meeting and have a record of the assessment of the results of clinical research on medical equipment.

In case the assessment meets the requirements, the National Ethics Council shall issue a Certificate of Acceptance of the results of clinical research on medical equipment.

In case the research results are not approved or need to be corrected, the National Ethics Council shall notify the research facility in writing and state the reasons. Within 60 days from the date of receipt of the notification, the medical equipment clinical research facility shall be responsible for completing the dossier and research results and sending them to the National Ethics Council. After this period, the research results approval procedure must be re-implemented from the beginning.

Within 07 working days from receiving the complete revised and supplemented dossier, the National Ethics Council shall review. In case of meeting the requirements, the National Ethics Council shall issue a Certificate of acceptance of the research results. In case of disapproval, the National Ethics Council shall notify the clinical research facility in writing and state the reasons.

The profile will only be considered for amendments and supplements a maximum of 03 times.

4. Within 05 working days from the date of receipt of the Certificate of approval of research results and accompanying documents, the Ministry of Health shall decide to approve the results of clinical research on medical equipment.

Article 19. Responsibilities of organizations and individuals with medical equipment for clinical research

1. Compensate for damages to participants in clinical research on medical equipment if risks occur due to medical equipment research according to the provisions of law.

2. Sign a contract on clinical research of medical equipment with the facility receiving clinical research of medical equipment.

3. Be responsible before the law for the quality and safety of medical equipment provided by you.

Article 20. Responsibilities of facilities undertaking clinical research on medical equipment

1. Responsible for the results of clinical research on medical equipment.

2. Be responsible for the safety and ensure the rights of participants in clinical research on medical equipment and compensate for damages to participants in clinical research on medical equipment if there is a risk due to the fault of the facility undertaking clinical research on medical equipment according to the provisions of law.

3. Ensure honesty and objectivity in clinical research on medical equipment.

4. Economic and personnel independence from organizations and individuals with medical equipment for clinical research.

 

Chapter V

CIRCULATION OF MEDICAL EQUIPMENT

Section 1

CIRCULATION NUMBER, CIRCULATION CONDITIONS AND CONDITIONS OF THE ORGANIZATION PUBLISHING THE APPLIED STANDARDS OR REGISTERING FOR CIRCULATION

 Article 21. Circulation number of medical equipment

1. The circulation number of medical equipment is:

a) Number of published standards applicable to medical equipment of types A and B;

b) Registration certificate number for medical equipment of type C, D.

2. The owner of the circulation number is the organization that publishes the applicable standards for medical equipment of type A, B or the organization that is granted a certificate of registration for circulation for medical equipment of type C, D.

3. Validity of circulation number: The circulation number of medical equipment is valid indefinitely, except for cases where the circulation number of medical equipment is issued in accordance with regulations on emergency issuance of circulation numbers of medical equipment for the purpose of disease prevention and control, and overcoming the consequences of natural disasters and catastrophes. Based on the actual records of the medical equipment for which an emergency circulation number is requested, the Minister of Health shall decide on the specific validity period of the circulation number.

Article 22. Conditions for circulation of medical equipment

1. Medical equipment when circulating on the market must meet the following conditions:

a) Has a circulation number or import license as prescribed in this Decree, except for the cases prescribed in Clause 8, Article 3 and Article 24 of this Decree;

b) Have labels with full information according to current regulations of law on product labels;

c) There are instructions for use of medical equipment in Vietnamese;

d) Have information on the warranty facility, conditions and warranty period, except for single-use medical equipment as prescribed by the medical equipment owner or have documents proving that there is no warranty.

2. In case the information specified in Points c and d, 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 23. 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 certified to meet ISO 13485 quality management standards and is allowed to be circulated 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 37 of this Decree;

b) Medical equipment is recalled in the cases prescribed in Clauses 1 and 3, Article 38 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 circulation number for medical equipment falling into one of the cases specified in Clause 2, Article 38 of this Decree.

Article 24. Cases exempted from publishing applicable standards and exempted from registration for circulation

1. Medical equipment is only used for the purposes of research, testing, inspection, testing, quality assessment, training in the use and repair of medical equipment.

2. Medical equipment imported into Vietnam for the purpose of aid or humanitarian medical examination and treatment or to serve fairs, exhibitions, displays, product introductions or to be used as gifts for medical facilities or for personal treatment, specific personal needs or for special diagnostic needs of medical facilities.

3. Medical equipment without a circulation number is imported to meet urgent needs for disease prevention and control, and to overcome the consequences of natural disasters and catastrophes, for which there are no other medical equipment available on the market that can replace it.

4. Medical equipment manufactured in Vietnam is only for export purposes or for participation in exhibitions, fairs and exhibitions abroad.

Article 25. 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 authorized by the owner of 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 publishes 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 medical equipment, except for single-use medical equipment as prescribed by the owner of the medical equipment or has documents proving that there is no warranty.

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 capable of providing warranty for medical equipment, except for the case of single-use medical equipment as prescribed by the owner of the medical equipment or has documents proving that there is no warranty.

The warranty facility must be certified by the medical equipment owner as having the capacity to warranty the product.

 

Section 2

ANNOUNCEMENT OF CONTRACTS STANDARD APPLICABLE TO MEDICAL EQUIPMENT OF THIS TYPE A, B

 Article 26. Dossier for declaration of applicable standards

The dossier declaring the applicable standards for medical equipment of types A and B includes:

1. Document announcing applicable standards of medical equipment of types A and B.

2. ISO 13485 quality management certification valid at the time of application.

3. The authorization letter of the owner of the medical equipment for the organization declaring the applicable standards is still valid at the time of dossier submission, except for the case specified in Point a, Clause 1, Article 25 of this Decree.

4. Certificate of eligibility for warranty issued by the owner of the medical equipment, except for the case of single-use medical equipment as prescribed by the owner of the medical equipment or with documents proving that there is no warranty.

5. Documents summarizing the technical description of medical equipment in Vietnamese, accompanied by technical documents describing the functions and technical parameters of the medical equipment issued by the owner of the medical equipment.

For reagents, calibrators, and in vitro control materials: technical documents in Vietnamese with documents on raw materials, product safety, manufacturing processes, clinical and preclinical research reports including stability reports.

6. Certificate of conformity according to regulations or product standards published by the owner of the medical equipment.

Particularly for domestically produced medical equipment, the assessment results of chemical, physical, microbiological parameters and other parameters must be supplemented by a qualified facility as prescribed by law on conformity assessment or a Certificate of quality assessment issued by a competent authority of Vietnam for in vitro diagnostic medical equipment. The assessment results must comply with the standards announced by the owner of the medical equipment.

7. Instructions for use of medical equipment.

8. Label sample to be used when circulating medical equipment in Vietnam.

9. Free circulation certificate valid at the time of application for imported medical equipment.

Article 27. 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 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.

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 Conformity or Standard that the medical equipment owner declares to apply: Submit the original or 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 user manuals: Submit a Vietnamese copy certified by the organization that publishes the applicable standards, along with the original English copy issued by the owner of the medical equipment for imported medical equipment. In case the user manual 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 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 prescribed by law on product labels.

e) 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.

g) For the assessment results of chemical, physical, microbiological parameters and other parameters issued by a qualified facility as prescribed by law on conformity assessment or the Quality Assessment Certificate issued by a competent authority of Vietnam for in vitro diagnostic medical equipment: Submit the original or a certified copy.

Article 28. Procedures for announcing applicable standards

1. Before putting medical equipment of type A and B into circulation on the market, the establishment declaring the applicable standards is responsible for submitting the declaration dossier to the Department of Health where the business headquarters is located.

2. Upon receiving the dossier (including documents confirming payment of fees as prescribed by the Ministry of Finance), the Department of Health in the locality where the medical equipment business establishment is located shall publicly post the Announcement Number of applicable standards for medical equipment of types A and B on the Electronic Information Portal on medical equipment management and the dossier announcing applicable standards, except for the documents specified in Clause 5, Article 26 of this Decree.

3. In case of change of medical equipment owner, type of medical equipment, category, purpose of use, indication for use; addition of manufacturing facility, product code, the owner of the circulation number is responsible for re-declaring the applicable standards according to the provisions of this Decree.

4. During the circulation of medical equipment, the owner of the applicable standard declaration number is responsible for preparing a written notice of the change, along with documents related to the change, and updating those documents in the applicable standard declaration file publicly available on the Electronic Information Portal on Medical Equipment Management within 05 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 or the name of the medical equipment owner;

c) Change one of the information about the name or address of the medical equipment manufacturing facility;

d) Change packaging specifications;

d) Change of warranty facility;

e) Changing the label, changing the instructions for use but not changing the purpose of use or indications for use. Medical equipment manufactured before the date the owner of the applicable standard announcement number notifies the change of label shall be circulated with the information announced at the time of manufacture;

g) Reduce production facilities, product types and codes.

 

Section 3

REGISTRATION FOR MEDICAL EQUIPMENT OF TYPE C, D

 

Article 29. Forms of circulation registration

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:

– Owner of medical equipment; type of medical equipment; type, purpose of use, indication for use; quality standards; additional manufacturing facility, product code; manufacturing materials affecting the function of in vitro diagnostic medical equipment and disposable medical equipment; concentration, content, and composition of raw materials that are pharmaceutical substances combined in a medical device with the role of supporting treatment purposes;

– Not falling under the cases specified in Clause 7, Article 32 of this Decree.

2. Quickly issue new circulation numbers for medical equipment in one of the following cases:

a) Has been granted a Certificate of Free Sale or a Market Authorization (hereinafter referred to as the circulation certificate) by one of the following organizations or countries: the United States Food and Drug Administration (FDA) - USA; the Therapeutic Goods Administration (TGA) - Australia; the Canadian Health Canada; the Ministry of Health, Labour and Welfare of Japan (MHLW) or the Pharmaceutical and Medical Device Agency (PMDA) - Japan, EU member countries, UK, Switzerland; the National Medical Products Administration (NMPA) - China; the Ministry of Food & Drug Safety (MFDS) - Korea or is on the list of organizations granting circulation certificates recognized by the competent authority of Vietnam (hereinafter referred to as the reference country);

b) Has been granted an Import License or a Circulation Number or a Certificate of Registration for Commercial Circulation in Vietnam, except for cases that have been revoked before the effective date of this Decree;

3. Emergency issuance of new circulation numbers for medical equipment serving disease prevention and control, overcoming consequences of natural disasters and catastrophes in urgent cases on the List issued by the Minister of Health and falling into one of the following cases:

a) Has been approved for circulation or emergency use by one of the reference countries;

b) Belonging to the list of products for emergency use announced by the World Health Organization (WHO);

c) Belong to the list of popular products announced by the European Health Security Committee (EUHSC);

d) Has been granted a circulation number or a commercial import license in Vietnam, except for cases that have been revoked before the effective date of this Decree;

d) Domestically produced in the form of technology transfer for medical equipment falling into one of the cases specified in points a, b, c or d of this clause;

e) Domestically manufactured in the form of processing for medical equipment falling into one of the cases specified in points a, b, c or d of this clause.

Article 30. Application for new circulation number

1. Application for new circulation number for medical equipment with corresponding national technical regulations:

a) Document requesting new circulation number.

b) ISO 13845 quality management standard certificate valid at the time of application submission.

c) The authorization letter of the owner of the medical equipment for the facility to carry out the circulation registration is still valid at the time of dossier submission, except for the case specified in Point a, Clause 1, Article 25 of this Decree.

d) 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.

d) The circulation certificate is still valid at the time of application submission for imported medical equipment.

e) General technical dossier on medical equipment according to ASEAN regulations (hereinafter referred to as CSDT dossier).

g) Certificate of conformity.

2. 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 new circulation number.

b) Decision to approve the sample.

c) Documents as prescribed in points b, c, d, dd and e, Clause 1 of this Article.

3. Application for new circulation number issuance for medical equipment subject to express issuance as prescribed in Clause 2, Article 29 of this Decree:

a) Document requesting new circulation number.

b) Documents as prescribed in points b, c and d, Clause 1 of this Article.

c) Circulation certificate issued by one of the reference countries for the case specified in Point a, Clause 2, Article 29 of this Decree.

d) Circulation certificate for imported medical equipment and Import license or Circulation number or Circulation registration certificate for the case specified in Point b, Clause 2, Article 29 of this Decree.

d) Quality assessment certificate issued by a competent authority of Vietnam for in vitro diagnostic medical equipment, except in the following cases:

– Belonging to category A, B, appendix 2 of the Agreement on in vitro diagnostic medical devices in Europe and has been granted a Certificate of Free Sale by one of the EU member countries, UK, Switzerland;

– Belonging to category A, B of appendix 2 of the Agreement on in vitro diagnostic medical devices in Europe and has been granted a certificate of circulation (Market Authorization) by one of the reference countries;

– Not included in list A, B of appendix 2 of the Agreement on in vitro diagnostic medical devices in Europe but has been granted a certificate of circulation (Market Authorization) by one of the reference countries;

– Belonging to the list announced by the Minister of Health.

e) CSDT profile.

4. Application for new circulation number issuance for medical equipment in emergency cases specified in Clause 3, Article 29 of this Decree:

a) Document requesting new circulation number.

b) Documents as prescribed in points b, c and d, Clause 1 of this Article.

c) Circulation certificate or emergency use license for imported medical equipment.

d) Technology transfer contract for the case specified in Point d, Clause 3, Article 29 of this Decree.

d) Processing contract for the case specified in Point e, Clause 3, Article 29 of this Decree.

e) Certificate of inspection or product quality assessment of one of the units on the list published on the Ministry of Health's electronic information portal if one of the following cases applies:

– Domestically produced medical equipment;

– Medical equipment that has been approved for circulation and emergency use by competent authorities in EU member countries, the UK, and Switzerland but is not on the list of popular products published by the European Health Security Committee (EUHSC).

g) CSDT profile.

5. Application for new circulation number for other medical equipment:

a) Document requesting new circulation number.

b) Documents as prescribed in points b, c, d and dd, Clause 1 of this Article.

c) The results of the assessment of the CSDT dossier by the unit designated by the Minister of Health are attached to the CSDT dossier.

d) For in vitro diagnostic medical devices that are reagents, calibrators, and control materials, there must be an additional quality certificate issued by a competent authority of Vietnam.

d) For chemicals and preparations with the sole purpose of disinfecting medical equipment, there must be an additional Certificate of testing of ingredients and content of active disinfectants from a unit that has declared to be qualified to conduct testing according to the provisions of law on management of chemicals, insecticides and disinfectants used in the household and medical fields; Certificate of testing to assess the biological effectiveness of the product and the side effects of the product on test participants from a unit that has declared to be qualified to conduct testing according to the provisions of law on management of chemicals, insecticides and disinfectants used in the household and medical fields.

Article 31. Requirements for application dossiers for new circulation number issuance

1. Requirements for some documents in the registration dossier:

a) For certificates of 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 circulation papers: Submit the consularly legalized copy or a certified copy of the consularly legalized copy.

In case the circulation certificate 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 quality assessment certificates, test reports, examination reports and results of CSDT dossier appraisal: Submit the original or a certified copy or a copy confirmed by the facility requesting the circulation number.

d) For CSDT dossiers: Submit a copy certified by the organization requesting the circulation number. In case the CSDT dossier is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.

2. Requirements for some documents in the registration dossier for circulation in emergency cases specified in Clause 3, Article 29 of this Decree:

Documents issued by foreign countries must be consular legalized. In case of no consular legalization:

a) For authorization letters, the original must be provided with confirmation information.

b) For documents specified in Point c, Clause 4, Article 30 of this Decree, a link must be provided to look up information on the circulation and permission to use medical equipment from the website of the licensing authority, along with a document providing information on the lookup link of the organization requesting the circulation number. The results of the lookup of information on the circulation license on the website must include at least the following information in English: name; type; manufacturer, country of manufacture.

Article 32. Receiving and appraising medical equipment circulation registration dossiers

1. The organization requesting the issuance of a circulation number submits the application to the Ministry of Health through the Electronic Portal on Medical Equipment Management.

2. For medical equipment circulation registration dossiers specified in Clauses 1 and 2, Article 30 of this Decree:

a) In case there is no request to amend or supplement the registration dossier, the Minister of Health shall be responsible for: Organizing the appraisal to issue a circulation number within 30 days from the date of receiving a complete and valid dossier (including documents confirming the payment of the appraisal fee for granting a circulation license according to the regulations of the Ministry of Finance). In case of not issuing a circulation number, there must be a written response stating the reason.

b) In case the registration dossier is not complete, the Ministry of Health must notify the organization requesting the issuance of a circulation number to supplement or amend the registration dossier, specifically stating which documents need to be supplemented and which content needs to be amended within 25 days from the date of receiving the complete and valid dossier.

c) Upon receiving a request to supplement or amend the application for a circulation number, the facility requesting the circulation number must supplement or amend in accordance with the notified contents 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 at Point b, Clause 2 of this Article.

After 90 days from the date the Ministry of Health issues a notice requesting the facility to 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 the 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.

3. For medical equipment circulation registration dossiers specified in Clause 3, Article 30 of this Decree:

a) In case there is no request to amend or supplement the registration dossier, the Minister of Health shall be responsible for: Organizing the appraisal to issue a circulation number within 10 working days from the date of receiving a complete and valid dossier (including documents confirming the payment of the appraisal fee for granting a circulation license according to the regulations of the Ministry of Finance). In case of not issuing a circulation number, there must be a written response stating the reason.

The Ministry of Health shall only appraise the legal documents specified in Points b, c, d and dd, Clause 1, Article 30 of this Decree. For other contents, the organization requesting the issuance of a circulation number shall be responsible for the accuracy and legality of these documents. The Ministry of Health shall conduct post-inspection of these contents after the issuance of the circulation number.

b) In case the registration dossier is not complete, the Ministry of Health must notify the organization requesting the issuance of a circulation number to supplement or amend the registration dossier, specifically stating which documents need to be supplemented and which content needs to be amended within 10 working days from the date of receiving the complete and valid dossier.

c) Upon receiving a request to supplement or amend the application for a circulation number, the facility requesting the circulation number must supplement or amend in accordance with the notified contents 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 at Point b, Clause 3 of this Article.

After 90 days from the date the Ministry of Health issues a notice requesting the facility to 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 the 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.

4. For medical equipment circulation registration dossiers specified in Clause 4, Article 30 of this Decree:

a) In case there is no request to amend or supplement the registration dossier, the Minister of Health shall be responsible for: Organizing the appraisal to issue a circulation number within 10 working days from the date of receiving a complete and valid dossier (including documents confirming the payment of the appraisal fee for granting a circulation license according to the regulations of the Ministry of Finance). In case of not issuing a circulation number, there must be a written response stating the reason.

The Ministry of Health shall only appraise the legal documents specified in Points b, c, d, dd and e, Clause 4, Article 30 of this Decree. For other contents, the organization requesting the issuance of a circulation number shall be responsible for the accuracy and legality of these documents. The Ministry of Health shall conduct post-inspection of these contents after the issuance of the circulation number.

b) In case the registration dossier is not complete, the Ministry of Health must notify the organization requesting the issuance of a circulation number to supplement or amend the registration dossier, specifically stating which documents need to be supplemented and which content needs to be amended within 08 working days from the date of receiving the complete and valid dossier.

c) Upon receiving a request to supplement or amend the application for a circulation number, the facility requesting the circulation number must supplement or amend in accordance with the notified contents 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 at Point b, Clause 4 of this Article.

After 90 days from the date the Ministry of Health issues a notice requesting that the facility does not supplement or amend the dossier, it must re-do the procedure for requesting a circulation number from the beginning.

5. For medical equipment circulation registration dossiers specified in Clause 5, Article 30 of this Decree:

a) In case there is no request to amend or supplement the registration dossier, the Minister of Health shall be responsible for: Organizing the appraisal to issue a circulation number within 45 days from the date of receiving a complete and valid dossier (including documents confirming the payment of the appraisal fee for granting a circulation license according to the regulations of the Ministry of Finance). In case of not issuing a circulation number, there must be a written response stating the reason.

b) In case the registration dossier is not complete, the Ministry of Health must notify the organization requesting the issuance of a circulation number to supplement or amend the registration dossier, specifically stating which documents need to be supplemented and which content needs to be amended within 40 days from the date of receiving the complete and valid dossier.

c) Upon receiving a request to supplement or amend the application for a circulation number, the facility requesting the circulation number must supplement or amend in accordance with the notified contents 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 at Point b, Clause 5 of this Article.

After 90 days from the date the Ministry of Health issues a notice requesting the facility to 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 the 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.

6. Within 01 working day from the date of issuance of the circulation number, the Ministry of Health is responsible for publicizing the following information on the Electronic Information Portal on Medical Equipment Management:

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) Documents in the medical equipment circulation registration dossier, except for documents specified in Point e, Clause 1 and Point c, Clause 5, Article 30;

g) Purpose of use of medical equipment.

7. During the process of circulating medical equipment, the owner of the circulation number is responsible for preparing a written notice of change with documents related to the change and updating those documents in the circulation registration file publicly available on the Electronic Information Portal on Medical Equipment Management 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 or the name of the medical equipment owner;

c) Change one of the following information: name, address of medical equipment manufacturing facility;

d) Change packaging specifications;

d) Change of warranty facility;

e) Changing the label, changing the instructions for use but not changing the purpose of use, indications for use, features, and performance of the medical equipment. Medical equipment manufactured before the date the circulation number owner notified the label change shall be circulated with the information registered and updated at the time of manufacture.

 

Section 4

POST-SALES MANAGEMENT OF MEDICAL EQUIPMENT AND HANDLING OF MEDICAL EQUIPMENT IN SOME SPECIAL CASES

 

Article 33. Requirements for post-sales medical equipment management records

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 number issuance 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 25 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 sale or certificate of 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 include:

a) Certificate of origin is made in accordance with the provisions of law 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 55 of this Decree;

d) Have technical documents to serve the repair and maintenance of medical equipment, except for medical equipment used once as prescribed by the owner of the medical equipment or have documents proving that there is no warranty;

d) There is information on instructions for use of medical equipment in Vietnamese;

e) Have information on the warranty facility, conditions and warranty period, except for single-use medical equipment as prescribed by the medical equipment owner or have documents proving that there is no warranty.

Article 34. Handling of cases where medical equipment has warnings of potential risks that seriously threaten public health or may lead to death for users

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 the 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 55 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 35. Handling of cases where medical equipment has had an incident that affects the health of the user

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 34 of this Decree.

Article 36. Forms of handling, remedying and recalling defective medical equipment

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 the cases specified in Article 39 of this Decree.

Article 37. 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 the commitment dossier to the Ministry of Health through the electronic portal on medical equipment management 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) Commitment document to be responsible for warranty, maintenance and provision of materials for the use of medical equipment;

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 NUMBERS

Article 38. Cases of revocation of circulation numbers

1. Organizations registering for circulation of fake registration documents.

2. Medical equipment has 03 batches recalled during the period of validity of the circulation number, except in cases where the owner of the circulation 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 37 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 circulation number owner or distribution facility does not have a commitment as prescribed in Clauses 1 and 2, Article 37 of this Decree.

8. Medical equipment whose circulation period has expired as prescribed in Clauses 1 and 2, Article 37 of this Decree.

9. Medical equipment manufactured at facilities that do not meet the conditions specified in this Decree.

10. The owner of the circulation number does not comply with the provisions at Point k, Clause 3, Article 74 of this Decree, except for the case specified in Article 37 of this Decree.

11. The circulation registration and announcement dossier of the circulation number owner is not in accordance with the provisions of this Decree.

12. Medical equipment is not classified properly according to regulations on medical equipment classification.

13. The owner of the circulation number voluntarily revokes the circulation number.

Article 39. 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, 7, 8, 9, 10, 11 and 12, Article 38 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) 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 information portal of the circulation number issuing agency.

4. 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 directing specialized agencies to supervise the recall of medical equipment.

5. In case the owner of the circulation number voluntarily revokes the circulation number, the owner of the circulation number shall send a document stating the reason for the request to revoke the circulation number to the circulation number issuing authority. After receiving the request, the circulation number issuing authority shall carry out the revocation in accordance with Clauses 2 and 3 of this Article.

 

Chapter VI

MEDICAL EQUIPMENT PURCHASE MANAGEMENT

Section 1

CONDITIONS FOR PURCHASE AND SALE OF MEDICAL EQUIPMENT

 

Article 40. Conditions for establishments trading in medical equipment of types B, C, D

1. Have at least 01 technical staff with a college degree in engineering, medicine, pharmacy, chemistry, biology 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, away from 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 facility to the delivery location appropriate to the type of medical equipment being traded by the trading facility.

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 No. 80/2001/ND-CP dated November 5, 2001 of the Government guiding the control of drug-related activities in the country.

c) Have a system to monitor and manage the export, import, and inventory of medical equipment containing narcotic substances and precursors.

Article 41. Records and procedures for declaring eligibility to purchase and sell medical equipment

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;

b) Personnel declaration;

c) Documents proving that the warehouse and means of transporting medical equipment meet the requirements specified in Clause 2, Article 40 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 40 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, the medical equipment purchasing and selling facility is responsible for submitting a declaration dossier to the Department of Health where the purchasing and selling location is located.

b) Upon receiving the dossier (including documents confirming payment of fees as prescribed by the Ministry of Finance), the Department of Health in the locality where the medical equipment trading facility is located shall publicly post on the electronic portal on medical equipment management the information and dossier declaring eligibility to trade medical equipment.

c) During the operation, the trading establishment is responsible for preparing a written notice of change with documents related to the change and updating those documents in the publicly announced dossier on the electronic portal on medical equipment management within 03 working days from the date of change in information in the announced dossier.

Article 42. Buying and selling medical equipment without having to meet 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 40 of this Decree and does not have to declare eligibility for purchase and sale as prescribed in Article 41 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
MEDICAL EQUIPMENT PRICE MANAGEMENT

Article 43. Principles of state management of medical equipment prices

1. Manage medical equipment prices according to market mechanisms, respect the right to self-determine prices and compete on prices of organizations and individuals trading in medical equipment according to the provisions of law.

2. Ensure public and transparent prices of medical equipment when circulating on the market.

3. Protect the legitimate rights and interests of business and user organizations and individuals and the interests of the State.

4. Implement measures to manage medical equipment prices in accordance with socio-economic development conditions in each period.

Article 44. Measures to manage medical equipment prices

1. Declare the price of medical equipment before circulating in Vietnam and update when there is a change in the declared price of medical equipment according to the provisions of this Decree.

2. Post wholesale and retail prices of medical equipment in Vietnamese Dong at the transaction location or medical equipment sales location of the medical equipment business establishment; publicly announce on a board, on paper or in other forms.

3. Publicize the winning bid prices for medical equipment of public health facilities.

4. Medical equipment must not be bought or sold without a declared price and must not be bought or sold at a price higher than the declared price on the Ministry of Health's electronic information portal at the time of purchase or sale.

Article 45. Contents and responsibilities for declaring medical equipment prices

1. Contents of medical equipment price declaration:

a) Name and type of medical equipment;

b) Country of manufacture;

c) Unit of measurement;

d) Import cost for imported medical equipment or production cost for domestically produced medical equipment;

d) Expected profit;

e) Maximum selling price of medical equipment corresponding to each configuration and technical feature by unit of calculation;

g) Price of components and accessories (if any);

h) Warranty, maintenance and repair costs (if any);

i) Training costs (if any);

k) Other costs (if any);

2. Content of public disclosure of medical equipment prices:

a) Name and type of medical equipment;

b) Manufacturer, country; owner, country;

c) Unit of measurement;

d) Maximum selling price of medical equipment corresponding to each configuration and technical feature by unit of calculation;

d) Price of components and accessories (if any);

e) Warranty, maintenance and repair costs (if any);

g) Training costs (if any);

h) Other costs (if any);

3. Prices of medical equipment are calculated in Vietnamese currency.

4. The owner of the medical equipment circulation number is responsible for:

a) Declare prices including all information specified in Clause 1 of this Article and post the information on the Ministry of Health's electronic portal before putting the first medical equipment into circulation on the Vietnamese market;

b) Update medical equipment prices when there are changes;

c) Designate a distributor to implement the provisions at Points a and b of this Article for the case specified at Point c, Clause 1, Article 25 of this Decree. In case there are many distributors distributing the same item, the owner of the medical equipment circulation number must designate a distributor to declare the price. Other distributors are not required to declare the price but must not sell at a price higher than the price declared by the designated distributor;

d) Declare and explain price components to tax authorities or when requested by state authorities.

5. The public price on the electronic portal of the Ministry of Health includes all the information specified in Clause 2 of this Article.

Section 3

EXPORT, IMPORT MEDICAL EQUIPMENT

Article 46. 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 and import and must be responsible for ensuring the quality, quantity, type and purpose of use of the medical equipment they export and import.

2. Medical equipment with circulation numbers in Vietnam can be exported and imported according to demand, without quantity restrictions and without approval from the Ministry of Health.

3. The issuance of a certificate of free circulation applies to medical equipment according to the provisions of law on foreign trade management.

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 law on foreign trade management.

Article 47. Export and import of medical equipment

1. Encourage domestic enterprises to produce for export.

2. 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 40 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 40 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 48. Import license

1. Cases requiring an import license:

a) Medical equipment without a circulation number is imported only to serve scientific research, inspection, testing, trial, quality assessment or training on the use and repair of medical equipment;

b) Medical equipment without a circulation number imported to meet urgent needs for disease prevention and control, and overcoming the consequences of natural disasters and catastrophes;

c) Medical equipment without a circulation number imported for the purpose of aid, humanitarian aid; gifts for medical facilities; for fairs, exhibitions, displays or product introductions;

d) 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 treatment purposes includes specific personal medical equipment or medical equipment according to special diagnostic needs of medical facilities;

e) Used medical equipment:

– Imported for research and training purposes (not for human practice and not for use of these medical devices for diagnostic and treatment purposes);

– Temporary import and re-export for display, introduction, participation in fairs and trade exhibitions.

Records, procedures and formalities for importing, temporarily importing and re-exporting medical equipment shall comply with the provisions of law on foreign trade management.

2. Import license application includes:

a) Document requesting import license;

b) Documents summarizing the technical description of medical equipment in Vietnamese;

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) In case of import for the purpose of inspection, testing, examination and quality assessment, there must be an additional confirmation document from the competent authority performing the inspection, testing, examination and quality assessment, clearly 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) In case of import as a gift or donation to a medical facility, there must be an additional copy of the document showing the content of the donation or donation and a document 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 to serve humanitarian medical examination and treatment activities, 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 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;

l) In case of import for personal medical treatment purposes, including personal specific medical equipment, there must be an additional copy of the doctor's prescription appropriate to the disease of the individual requesting the import;

m) In case of import for use in fairs, exhibitions, displays or product introductions, there must be additional copies of documents on the program, invitations and implementation contracts;

n) In case of import to meet urgent needs of disease prevention and control, and overcoming consequences of natural disasters and catastrophes, the following additional documents are required:

– Approval document of competent authority for urgent needs in disease prevention, overcoming consequences of natural disasters and catastrophes;

– Documents proving that the medical equipment proposed for import has been permitted for circulation or emergency use by a competent authority, with confirmation from the organization or individual requesting the import license.

3. Procedure for reviewing requests for medical equipment import licenses:

a) In case there is no request to amend or supplement the application for a license to import medical equipment, the Ministry of Health shall be responsible for: Organizing the appraisal to grant an import license within 15 working days and 02 working days for medical equipment without an import circulation number to meet urgent needs of disease prevention, overcoming the consequences of natural disasters and catastrophes, from the date of receiving a complete and valid application (including documents confirming the payment of the appraisal fee for granting an import license according to regulations of the Ministry of Finance). In case of refusal to grant, there must be a written response stating the reason.

Import license is sent to the organization or individual requesting the import and the customs authority.

b) In case the application for a license to import medical equipment is not complete, the Ministry of Health must notify the organization or individual requesting a license to import medical equipment to supplement or amend the application, specifically stating which documents need to be supplemented and which content needs to be amended within 10 working days and 02 working days for medical equipment without an import circulation number to meet urgent needs for disease prevention and control, overcoming the consequences of natural disasters and catastrophes, from the date of receiving a complete and valid application.

c) Upon receiving a document requesting to supplement or amend the import dossier, the organization requesting the import 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 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 30 days from the date the Ministry of Health issues a written request, if the organization or individual requesting an import license does not supplement or amend the application, it must start over.

d) If there are no further requests for additions or amendments, the Ministry of Health shall be responsible for granting an import license in accordance with the provisions of Point a of this Clause. The import license shall be sent to the organization or individual requesting the import and the customs authority.

Article 49. Application dossier for free circulation certificate for medical equipment

1. Application for a certificate of free circulation of medical equipment:

a) Document requesting a certificate of free circulation.

b) Submit a certified copy of the quality standard certificate issued by a conformity assessment organization in accordance with the provisions of law that is still in effect at the time of application submission.

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.

Article 50. 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 4

RIGHTS AND OBLIGATIONS OF ORGANIZATIONS AND INDIVIDUALS PARTICIPATING IN MEDICAL EQUIPMENT PURCHASE AND SALE ACTIVITIES

Article 51. 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 or the warranty facility certified by the owner of the medical equipment to perform 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 52. 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 use of medical equipment; conditions for ensuring safety, preservation, calibration, inspection, maintenance and repair of medical equipment;

b) Notification of defective medical equipment.

3. Publicly disclose and list prices according to the provisions of law. Medical equipment may not be bought or sold without a declared price and may not be bought or sold at a price higher than the public price on the Ministry of Health's electronic information portal at the time of purchase or sale.

4. Maintain medical equipment tracking records and trace the origin and recall medical equipment according to the provisions of this Decree.

5. Promptly notify the circulation number owner and the State management agency of cases of defective medical equipment.

6. Comply with legal regulations and inspection and examination decisions of competent state agencies.

7. Other obligations as prescribed by law.

 

Chapter VII
MEDICAL EQUIPMENT SERVICES

Section 1

TECHNICAL EQUIPMENT CONSULTATION

Article 53. 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 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 publicly disclosed information and declared their eligibility to provide advice on medical equipment technology as prescribed in Point b, Clause 2, Article 54 of this Decree.

Article 54. 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;

b) Certified copies of diplomas and certificates as prescribed in Point a and Point c, Clause 2, Article 53 of this Decree;

c) Confirmation of working time.

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 declaration dossier to the Ministry of Health.

b) Upon receiving the dossier (including documents confirming payment of fees as prescribed by the Ministry of Finance), the Ministry of Health shall publicly post on the electronic portal on medical equipment management the information and dossier declaring eligibility for consulting on medical equipment technology.

c) During the operation, the consultant is responsible for preparing a written notice of change with documents related to the change and updating those documents in the public declaration file on the electronic portal on medical equipment management within 03 days from the date of change in information in the declaration file.

 

Section 2

INSPECTION, VALIDATION STANDARD MEDICAL EQUIPMENT

Article 55. 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 57 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 56. Conditions for business of medical equipment inspection services

Conditions on facilities and personnel; application documents for Certificate issuance; form of application submission; procedures for new issuance, supplementary issuance, re-issuance and revocation of Certificate 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 57. 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 is imported for the purpose of medical treatment of the individual importer 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 58. Handling of medical equipment that does not meet 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 numbers 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 the suspension of use of the medical equipment.

Based on the re-inspection results, the Ministry of Health will decide to continue re-inspection, add 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 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 mark;

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 VIII

MANAGEMENT OF RAW MATERIALS FOR PRODUCING MEDICAL EQUIPMENT, EXTERNAL CONTROLLED SUBSTANCES CONTAINING NARCOTICS AND PRECURSORS

Article 59. Principles for managing raw materials for the production of medical equipment and externally controlled substances containing narcotic substances and precursors

1. Raw materials for the production of medical equipment and externally controlled substances containing narcotics and precursors must have their concentrations and contents declared before being exported or imported into Vietnam.

2. Customs clearance must be based on the announcement number and does not require an import license from the Ministry of Health.

Article 60. Dossier and procedures for declaration of raw materials for the production of medical equipment and externally controlled substances containing narcotic substances and precursors

1. Announcement documents:

a) Document declaring raw materials for manufacturing medical equipment and externally controlled substances containing narcotic substances and precursors;

b) Quality management certificate;

c) Technical documents.

2. Procedures for declaring drug and precursor concentrations and content:

a) Before importing raw materials for manufacturing medical equipment and externally controlled substances containing narcotics and precursors, the importing facility is responsible for posting a complete and valid declaration dossier as prescribed in Clause 1 of this Article on the electronic information portal on medical equipment management;

b) After receiving complete and valid dossiers, the Ministry of Health shall publicly post on the Electronic Portal on Medical Equipment Management information and declaration dossiers for raw materials for manufacturing medical equipment and externally controlled substances containing narcotic substances and precursors.

3. Import and export establishments are responsible for re-declare the concentration and content of drugs and precursors when there are any changes in the declared records.

 

Chapter IX
MEDICAL EQUIPMENT INFORMATION

Article 61. 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 62. Advertising of medical equipment

1. Medical equipment advertising content must comply with one of the following documents:

a) Documents declaring applicable standards for medical equipment of types A and B;

b) Registration dossier for circulation of medical equipment of type C, D.

2. Medical equipment advertisements must have the following content:

a) Name of medical equipment, type, product code, manufacturer, country of manufacture;

b) Circulation number;

c) Features and functions;

d) Name and address of the owner of the medical equipment circulation number or the organization authorized by the owner of the medical equipment circulation number;

d) Warnings related to user health and storage conditions (if any).

3. Advertisements for medical equipment in newspapers and television must read or clearly show the content specified in Clause 2 of this Article.

4. Before advertising, the owner of the medical equipment circulation number or the organization authorized in writing by the owner of the medical equipment circulation number is responsible for publicly posting on the electronic portal on medical equipment management the expected content and form of advertising.

5. The owner of the medical equipment circulation number or the organization authorized by the owner of the medical equipment circulation number shall be responsible before the law for the conformity of the advertising content with the proposed posted advertising content and the dossier declaring applicable standards for medical equipment of type A, B or the circulation registration dossier for medical equipment of type C, D.

6. Documents or items that do not mention the name of the medical equipment; documents or items that only list the name and technical specifications of the medical equipment but do not contain information on features and effects; scientific research documents; clinical documents; training support documents providing instructions for product use are not considered advertising documents.

Chapter X

MANAGEMENT AND USE OF MEDICAL EQUIPMENT AT MEDICAL FACILITIES

Article 63. 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. Medical equipment must be stored, maintained, serviced, 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 64. Management and use of medical equipment in State medical facilities

In addition to managing and using medical equipment as prescribed in Article 63 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 65. Rights and responsibilities of medical facilities in managing and using medical equipment

1. Medical facilities have the right to:

a) Require the owner of the circulation number or the warranty facility certified by the owner of the medical equipment 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 cases of defective medical equipment and other information as required by competent state agencies.

Chapter XI
ANNOUNCEMENT, ONLINE REGISTRATION

Article 66. Procedures performed online

1. Announcement of eligibility to manufacture medical equipment.

2. Announcement of standards applicable to medical equipment.

3. Registration of medical equipment circulation.

4. Announcement of eligibility to buy and sell medical equipment.

5. Announcement of eligibility for consulting on medical equipment technology.

6. Request for certificate of registration for medical equipment inspection activities.

7. Request for license to import medical equipment.

8. Request for free circulation certificate for domestically produced medical equipment.

9. Declaration of medical equipment prices.

10. Announce the concentration and content of raw materials for the production of medical equipment and externally controlled substances containing narcotics and precursors.

11. Publicize the content and form of advertising medical equipment.

Article 67. Requirements for online 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 meeting 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 68. Online announcement procedures

1. The legal representative or the person authorized by the legal representative declares information, uploads electronic documents, confirms with digital signature (if any) and pays the fee online according to the process on the electronic portal on medical equipment management.

2. The agency receiving online registration dossiers shall carry out administrative procedures corresponding to the registration dossiers as prescribed in this Decree.

3. The results of online administrative procedures have the same legal value as the results of administrative procedures resolved by conventional methods.

Article 69. Storage of online registration records

1. In case of online registration, the registration facility must keep a paper copy of the registration dossier as prescribed in Clause 1, Article 33 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 information portal related to medical equipment manufacturing facilities, medical equipment trading facilities, medical equipment technical consultants, raw materials for medical equipment manufacturing, externally inspected substances containing narcotics and precursors, medical equipment inspection facilities, and equipment circulation numbers;

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 XII
IMPLEMENTATION ORGANIZATION

Article 70. 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.

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) Price of medical equipment declared by the enterprise;

b) Winning bid price for purchasing medical equipment of State medical facilities nationwide;

c) List of medical equipment whose circulation numbers have been revoked.

6. Decide to apply or exempt the provisions of this Decree in cases where products and goods are managed as medical equipment by some countries but not managed as medical equipment by other countries.

7. Inspect, examine, resolve complaints, denunciations and handle violations of the law in the field of medical equipment. During the process of inspection and control of medical equipment prices, if it is discovered that the price declaration facility does not fully disclose information related to the price of medical equipment, the competent state management agency of the Ministry of Health shall notify the price declaration facility to review the information related to the declaration and clearly state the reason.

8. Update and publish the list of organizations specified in Point a, Clause 2, Article 29 of this Decree.

9. Provide detailed regulations on the classification of medical equipment to ensure compliance with international treaties on the classification of medical equipment of the Association of Southeast Asian Nations of which Vietnam is a member; issue a training program on the practice of classifying medical equipment.

10. Issue a list of medical equipment that must be inspected and the inspection process for each type of medical equipment in the list.

11. Specific instructions on how to record in the general technical dossier on medical equipment according to ASEAN regulations.

12. Specify the forms guiding the implementation of this Decree.

Article 71. 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 72. 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.

3. Inspect, examine and sanction violations of the law on medical equipment prices.

Article 73. 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 74. 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. Domestic medical equipment manufacturing facilities are responsible for managing the quality of medical equipment during the production, transportation, and storage of medical equipment in accordance with the records that have been granted a circulation number.

3. The owner of the circulation number is responsible for:

a) Carry out classification and publication on the electronic information portal of the Ministry of Health and be legally responsible for the classification results of the medical equipment that it has classified;

Take remedial measures for cases of issuing incorrect classification results that reduce the risk level of medical equipment or issuing incorrect classification results on the authority prescribed in this Decree.

b) Implement the announcement of applicable standards or registration of circulation of medical equipment according to the provisions of this Decree. Be responsible before the law for the accuracy and honesty of the application for circulation number issuance;

c) Establish and maintain a medical equipment warranty facility or sign a contract with a medical equipment warranty facility, except for single-use medical equipment as prescribed by the medical equipment owner or with documents proving that there is no warranty;

d) 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 police when discovering the loss of medical equipment containing narcotics and precursors, or raw materials for the production of 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;

e) 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;

g) 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;

h) Comply with legal regulations and inspection and examination decisions of competent state agencies;

i) Compensate for damages according to the provisions of law when medical equipment is defective;

k) Responsible for ensuring that the following documents remain valid during the period the circulation number is valid:

– Circulation certificate for imported medical equipment;

– Power of attorney, except for the case specified in Point a, Clause 1, Article 25 of this Decree;

– Certificate of eligibility for warranty, except for single-use medical equipment as prescribed by the medical equipment owner, or document proving that there is no warranty.

l) 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;

m) Be responsible before the law for the legality and accuracy of posted documents when performing procedures in this Decree;

n) Provide the medical facility where the medical equipment is purchased with 01 set of management records specified in Clause 4, Article 33 of this Decree for that medical equipment;

o) Declare and update the selling price of medical equipment or designate an organization to declare and update the selling price of medical equipment;

р) Other obligations as prescribed by law.

4. Establishments that purchase, sell, export, import, and transfer medical equipment, production materials, and externally controlled substances containing narcotics and precursors are responsible for reporting to the Ministry of Health and the Ministry of Public Security annually before January 15 of the following year.

Chapter XIII
TERMS OF IMPLEMENTATION

Article 75. Entry into force

1. This Decree comes into force from January 1, 2022.

2. The following Decrees cease to be effective from the effective date of this Decree:

a) Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on medical equipment management;

b) 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;

c) 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 management of medical equipment, as amended and supplemented by 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 management of medical equipment.

3. Abolish the provisions in Article 7 of Decree No. 181/2013/ND-CP dated November 14, 2013 of the Government detailing the implementation of a number of articles of the Law on Advertising from July 1, 2022.

Article 76. Transitional provisions

1. 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 in accordance with the law on management and use of public assets or until the expiry date stated on the circulation registration certificate or until the expiry date of the product.

2. Regulations on the value of circulation numbers and import licenses issued before January 1, 2022:

a) Medical equipment that has been granted a circulation number according to the provisions of Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on the management of medical equipment, as amended and supplemented by Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP (hereinafter referred to as Decree No. 36/2016/ND-CP), this circulation number is valid indefinitely;

b) For domestically produced medical equipment that has been granted a certificate of registration for circulation, the certificate of registration for circulation is valid until the expiry date stated on the certificate of registration for circulation;

c) Medical equipment other than in vitro diagnostic biological products that have been granted an import license since January 1, 2018, the import license is valid until December 31, 2022;

d) For medical equipment that is not on the list requiring an import license (except for chemicals, insecticides, disinfectants used in the household and medical fields with the sole purpose of disinfecting medical equipment) and has been classified as medical equipment of type C, D and announced by the Ministry of Health on the electronic information portal, it can continue to be imported until December 31, 2022 according to demand, without quantity restrictions and without the need for a document confirming that it is medical equipment from the Ministry of Health when carrying out customs clearance procedures;

d) Medical equipment that is an in vitro diagnostic biological product that has been granted a circulation registration number from January 1, 2014 to December 31, 2017, this circulation registration number is valid until December 31, 2022;

e) Medical equipment that is an in vitro diagnostic biological product that has been granted a circulation registration number from January 1, 2018, this circulation registration number is valid until the expiration date stated on the circulation registration certificate;

g) For imported in vitro diagnostic biological products that have been granted an import license since January 1, 2018, this import license is valid until December 31, 2022 and does not limit the import quantity. The Customs authority does not control the import quantity in this case.

3. Applications for circulation registration numbers submitted in accordance with Decree No. 36/2016/ND-CP before January 1, 2022, up to the effective date of the Decree, which have not been granted a circulation number, shall be handled as follows:

a) For registration dossiers for circulation of medical equipment of type B, the Ministry of Health guides enterprises that have submitted dossiers to conduct reviews to implement the announcement of applicable standards according to the provisions of this Decree without having to re-pay the circulation license appraisal fee;

b) For registration dossiers for circulation of medical equipment of type C and D, if they meet the conditions specified in Clause 3, Article 30 of this Decree, the Ministry of Health shall be granted a circulation number according to the procedures specified in Article 32 of this Decree;

c) Use the classification results of the classification organization that has been granted a Receipt of dossier declaring eligibility to classify medical equipment before the effective date of this Decree in the application for circulation number issuance.

4. Applications for import licenses for medical equipment submitted before January 1, 2022 shall continue to be processed in accordance with the provisions of legal documents issued by the Minister of Health before the effective date of this Decree. Import licenses granted under the provisions of this clause shall be valid until December 31, 2022.

5. Labels of medical equipment that have been manufactured in Vietnam or imported into Vietnam before the provisions in Clauses 2 and 4 of this Article shall continue to be used until the expiry date of the medical equipment or until it is liquidated according to the provisions of law on management and use of public assets or until the expiry date stated on the circulation registration certificate or until the expiry date of the product.

6. Regulations on the application of CSDT records:

a) Mandatory application of CSDT records from January 1, 2023.

b) The application for new circulation number has been submitted before December 31, 2022. The application for new circulation number includes the documents specified in Points a, b, d, dd, Clause 1, Article 30 of this Decree and the following documents:

– Documents summarizing the technical description of medical equipment in Vietnamese, accompanied by technical documents describing the functions and technical parameters of the medical equipment issued by the owner of the medical equipment.

For reagents, calibrators, and in vitro control materials: technical documents in Vietnamese with documents on raw materials, product safety, manufacturing processes and product quality control, clinical and preclinical research reports including stability reports.

– User manual of medical equipment.

– Label sample to be used when circulating medical equipment in Vietnam.

The above documents must meet the following requirements:

– For technical documents of medical equipment: Submit a copy certified by the organization requesting the circulation number.

– For medical equipment user manuals: Submit a Vietnamese copy certified by the organization requesting the circulation number, along with the original English copy issued by the owner of the medical equipment for imported medical equipment.

– For label samples: Submit a certified copy of the label sample from the organization requesting the circulation number. The label sample must meet the requirements prescribed by law on product labels.

c) The receipt and appraisal of medical equipment circulation registration dossiers specified in Point b of this Clause shall be carried out as follows:

– In case there is no request to amend or supplement the registration dossier, the Minister of Health shall be responsible for: Organizing the appraisal to issue a circulation number within 90 days from the date of receiving a complete and valid dossier (including documents confirming the payment of the appraisal fee for granting a circulation license according to the regulations of the Ministry of Finance). In case of not issuing a circulation number, there must be a written response stating the reason;

– In case the registration dossier is not complete, the Ministry of Health must notify the organization requesting the issuance of a circulation number to supplement or amend the registration dossier, specifically stating which documents need to be supplemented and which content needs to be amended within 70 days from the date of receiving the complete and valid dossier;

– Upon receiving a request to supplement or amend the application for a circulation number, the facility requesting the circulation number must supplement or amend in accordance with the notified contents 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 at Point b, Clause 6 of this Article.

After 90 days from the date the Ministry of Health issues a notice requesting the facility to 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 the 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.

7. Public disclosure of content and advertising of medical equipment shall be effective from July 1, 2022.

8. The owner of the circulation number or the facility named in the medical equipment import license granted before the effective date of this Decree must comply with the provisions in Clause 4, Article 45 of this Decree before April 1, 2022 for medical equipment in circulation on the Vietnamese market and before putting the medical equipment into circulation for the first time on the Vietnamese market.

Article 77. 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.

Recipient: – Central Party Secretariat; – Prime Minister, Deputy Prime Ministers; – Ministries, ministerial-level agencies, and government agencies; – People's Councils and People's Committees of provinces and centrally run cities; – Central Office and Party Committees; – Office of the General Secretary; – Office of the President; – Council of Nationalities and Committees of the National Assembly; – Office of the National Assembly; – Supreme People's Court; – Supreme People's Procuracy; – State audit; – National Financial Supervision Commission; – Social Policy Bank; – Vietnam Development Bank; – Central Committee of the Vietnam Fatherland Front; – Central agencies of organizations; – Government Office: BTCN, PCNs, Assistant to the Prime Minister, General Director of the Government Portal, Departments, Bureaus, affiliated units, Official Gazette; – Save: VT, KGVX (2).

GOVERNMENT Prime Minister DEPUTY PRIME MINISTER               Vu Duc Dam