Currently, companies that have completed the procedures for declaring their eligibility to self-classify medical equipment in Article 6 of Decree 36/2016 also have the right to issue medical equipment classification results to other companies. You can search for these units by accessing the Electronic Information Portal of the Department of Medical Equipment - Ministry of Health http://dmec.moh.gov.vn/van-ban-cong-bo. In the advanced search section, select the "Administrative procedures" criterion in the "Declaration of eligibility to classify medical equipment" box.

If you have a product catalog that needs to be classified into hundreds of items, choosing units with reasonable fee schedules is definitely a top priority. In addition, the following standards are equally important to achieve the ultimate goal of having a valid medical equipment circulation number:

– Legal business: customers need to clearly understand whether the service provider in this field complies with the law. It should be noted that only companies that have registered the business line "unclassified scientific and technological professional activities" with the level 4 industry code 7490 and with the registration detail "classification of medical equipment". For businesses that have registered to do business legally, the financial invoices they issue to pay for the service costs received are valid. We have noticed that currently, some businesses that simply trade in medical equipment are also participating in this classification service provision industry, regardless of the fact that the business registration and issuance of invalid invoices and documents can cause risks for customers.

– Foreign language skills: with most complex and high-tech medical equipment, you also need to look for units with a team of medical and legal experts who are fluent in English. According to MEDNOVUM’s experience, we cannot fully understand and classify many medical equipment if we only rely on translated technical documents.

– Understanding of registration procedures: the Ministry of Health’s guidance on promulgating applicable standards and registering medical equipment requires registrants to clearly understand the regulations on classifying medical equipment in order to prepare accurate, concise and complete registration dossiers. To do that, in the stage of preparing the medical equipment classification table, the classifier needs to clearly understand the grouping rules and regulations of the registration procedures.

Reviewing the dossiers announcing the standards for applying type A medical equipment on the Ministry of Health's electronic information portal, we have listed the following units providing medical equipment classification services that you can contact:

• College of Medical Equipment Engineering - Medical Equipment Service Center
• H & X Medical Equipment and Supplies Joint Stock Company
• Institute of Medical Equipment and Construction – Ministry of Health
• ADJ Vietnam Technology Co., Ltd.
• MEDNOVUM MEDICAL SERVICES AND TRADING COMPANY LIMITED

Comparing the administrative procedures, it is clear that the procedure for declaring eligibility for circulation of Type A medical equipment is currently quite simple. Importers only need to submit documents to the Electronic Information Portal, pay the fee and wait for the issuance of the declaration number. Therefore, some importers deliberately negotiate with the classification company to be able to get the lowest risk classification result (Type A) in cases where the classification criteria are unclear.

However, businesses need to understand that when post-checking the dossier declaring eligibility to circulate type A medical equipment, the first thing that the authorities will be interested in is the results of the classification of medical equipment. If the results of the classification of medical equipment do not comply with the classification principles prescribed in Circular 39/2016, your circulation announcement number will be revoked. As a result, all of your products that have entered the distribution channel may also be revoked. At the same time, the Inspection Team during post-checking can also conduct post-checking the classification of company X. If there are violations by the Classified Company X, the Inspection Team has the right to recommend the Ministry of Health to revoke the classification license of company X.

In case the medical equipment classifies different risk levels between two companies based on different principles and the interpretation of the principles used for classification is not clear which side is correct and consistent, the Ministry of Health will be the final agency to adjudicate and decide on the classification of the medical equipment.

One thing is for sure, the circulation number of that medical equipment will be revoked. Currently, you can find some cases of revocation of medical equipment circulation numbers due to errors in the classification results posted on the Ministry of Health's Electronic Information Portal.

In Official Dispatch 3608/BYT-TB-CT dated June 26, 2017 of the Ministry of Health, the Ministry of Health warned the units performing classification services to comply with the rules of Circular 39/2016 in issuing classification results and be responsible to the Ministry of Health for those results. However, according to MEDNOVUM's review, the Ministry of Health has not yet issued any documents stipulating administrative fines, withdrawing the number of declarations of eligibility for classification or any sanctions applied to violating classification units.

For businesses, the consequence of recalling the circulation number is having to recall medical equipment from the market along with many losses and business risks. Therefore, businesses need to be careful in choosing an experienced and reputable service provider when planning to use this service.

According to the provisions of Article 7 of Decree 36/2016, any enterprise that has a person performing the classification of medical equipment that meets the legal conditions can self-publish the results of the classification of medical equipment for itself. It should be noted that before self-classification, the enterprise must complete the procedure for declaring eligibility to classify medical equipment on the Online Public Service System for Medical Equipment Management of the Ministry of Health and only perform the classification after the Ministry of Health has issued a receipt for the declaration dossier.

According to the provisions of Decree 36/2016/ND-CP, the condition for personnel with a university degree in engineering or higher is determined to be a person with an Engineering Degree and is shown as an Engineering Degree, not a Bachelor's Degree. Thus, you are not qualified to be the person in charge of classifying medical equipment.

According to the provisions of Clause 2, Article 7 of Decree 36/2016/ND-CP, "The person classifying medical equipment must have time direct work on medical equipment technology at a medical equipment facility for 24 months or more”. Accordingly, this person must directly participate in processes related to medical equipment technology (such as production or repair). In this case, your task at the Hospital is only to manage medical equipment (not directly participate in processes related to medical equipment technology). Therefore, we believe that you are not qualified to be a person performing medical equipment classification.

According to the provisions of Clause 2, Article 7 of Decree 36/2016/ND-CP, You meet the requirements for:

Clause 2a, Article 7: Have a university degree in engineering.

Clause 2c, Article 7: Has been tested and recognized by the training facility as qualified to classify medical equipment according to the training program issued by the Ministry of Health.

You have worked at hospital B directly in the field of medical equipment engineering with an actual working time of over 24 months. However, the time you worked at the hospital in charge of medical equipment engineering is only counted from September 2016 (when you got your engineering degree) to April 2017 (when you quit your job), which is not enough for 24 months.

So, you are not qualified to be a medical equipment classifier.

Point b Clause 2 Article 7 Decree 36/2016 stipulates that the experience requirement for the person performing the classification of medical equipment is to have at least 24 months of direct technical work in medical equipment at one of the following units:

• Hospital or medical facility with beds
• Medical equipment training facility
• Medical Equipment Research Facility
• Medical equipment manufacturing facility
• Organization of medical equipment classification implementation
• Medical Equipment Management Agency

In your case, you have experience working at the Ministry of Health but under the General Department of Population and Family Planning, not the agency managing medical equipment, so it is not considered experience according to the above regulations.

According to Point b Clause 2 Article 7 Decree 36/2016, you are not considered qualified in terms of experience at a “production facility”. Please see further explanation in Answer to Question 5.

In principle, the company must be legally responsible for the classification results of the medical equipment that the company has classified (Clause 2, Article 6, Decree 36/2016). Staff mistakes due to professional reasons, negligence, or intentional reasons cannot be used to explain and exempt the Company from responsibility. In case the error is caused by the responsible staff, the Company can base on the provisions of the labor law on material responsibility to request compensation.

The classification results for medical equipment are valid for the entire life cycle of the product, unless the Ministry of Health concludes to cancel its validity. Current regulations do not have any provisions specifying the case of canceling the classification results for medical equipment at the request of the personnel in charge of the classification.

However, when the personnel in charge of classification ceases to work, your Company is considered no longer qualified to perform the classification of medical equipment. Your Company can only continue to perform the classification after recruiting new suitable personnel and completing the procedure for declaring eligibility to reclassify medical equipment.

If there is a circulation number: to avoid revocation and possible penalties for violations in the announcement/registration procedure, the Company should proactively send an official dispatch to the local Department of Health where the announcement is made/Ministry of Health (depending on the corresponding procedure) to request revocation of the announcement number and re-announcement procedure. This process is not yet integrated into the Online Public Service Portal for Medical Equipment Management, so you still have to use manual document methods.

When there is a new circulation number, the Company needs to update the product label because the label must contain the correct effective circulation number. Hopefully you will rarely encounter this situation!

The classification of medical equipment can be effective until the end of the product's life and lasts forever even when the medical equipment registration number expires. For medical equipment of type B, C or D, the circulation number is only valid for 5 years. When re-registering for a circulation number, you can still use the available classification results to complete the application.

It should be noted that if the product has a change in medical indication, a new classification must be made according to the new medical indication of the product. For example: self-suturing and cutting blade, used for indication in intestinal endoscopy. When re-registering the product, in case the product is expanded to cutting and suturing tissue in cardiac and thoracic surgery, the product must be re-classified.

The medical equipment your company intends to import for the purpose of displaying or participating in fairs and exhibitions is not subject to registration for circulation or publication of applicable standards, nor is it required to register for an Import License from the Ministry of Health (as prescribed in Article 19 and Article 42 of Decree 36/2016/ND-CP). In this case, the Company will follow the temporary import - re-export procedures for goods participating in fairs and exhibitions as prescribed in Article 53 of Decree 08/2015/ND-CP.

During the implementation of Circular 30/2015/TT-BYT, import licenses are issued per trip (valid for 1 year) for 49 specified types of medical equipment. Imported medical equipment not on this list can be imported without having to ask for permission from the Ministry of Health.

From mid-2017 (for type A medical equipment) and from the beginning of 2018 (type B, C and D medical equipment), according to the provisions of Decree 36/2016/ND-CP, medical equipment circulating on the market must have a valid circulation number or be licensed for import.

The circulation number for Class A medical equipment is the number of the receipt of the application for declaration of applicable standards that the enterprise submits to the Department of Health of the provinces through the Ministry of Health's electronic information portal, which is valid until the end of the product's life cycle.

The circulation number for medical equipment classified B, C or D is the circulation registration certificate number issued by the Ministry of Health with a validity period of 5 years from the date of issue.

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

Depending on whether the Company has designated a distributor in Vietnam or not, we divide the answer into 2 cases as follows:

Case 1: The manufacturer has appointed a distributor in Vietnam. After announcing the eligibility for medical equipment trading procedures on the electronic information page, this distributor must register the medical equipment circulation number to be able to import and distribute medical equipment from abroad.

Case 2: Foreign traders do not have a distribution unit in Vietnam. According to Point c, Clause 1, Article 21 of Decree 36/2016/ND-CP, foreign traders can establish a representative office in Vietnam to register the circulation number of medical equipment imported into Vietnam. In this case, foreign traders must have an agreement with a qualified facility to guarantee the medical equipment they declare or register if the goods are not single-use medical equipment.

ZZZ Enterprise can import and trade medical equipment with the circulation number that YYY has been granted if ZZZ is authorized by YYY to use the circulation number. The authorization letter is submitted with the import dossier when carrying out customs clearance procedures.

To circulate a medical device in Vietnam, a foreign manufacturer can:

(A) by establishing a Representative Office to become the owner of the circulation number itself;

(B) authorize an exclusive distributor to own the circulation number in Vietnam; or

(C) authorize multiple distributors to carry out circulation procedures at the same time.

In case (C), a medical device will have multiple circulation numbers owned by different entities with the same validity.

Questions for this question are answered in detail by the Ministry of Health at Official dispatch 1527/BYT-TB-CT March 28, 2017.

Some documents in the registration dossier, if issued by foreign agencies or organizations, must be consularly legalized for legal use in Vietnam, including: Certificate of Free Sale (CFS), Authorization letter of the owner of the medical equipment, Certificate of qualified warranty facility.

In addition, if the document is not written in English, it must be accompanied by a Vietnamese translation and the translation must also be certified.

According to Mednovum's experience, consular legalization is only valid for 3 months from the date of application.

Currently, MedNovum knows that many registration documents for circulation numbers are not approved by competent authorities simply because the attached documents (authorization letter, technical description document...) are not prepared according to the prescribed form. According to point c, clause 2, Article 23 of Decree 36/2016, for imported medical equipment, the owner's authorization letter, in addition to being consular legalized, must also be prepared according to Form No. 2. Official dispatch 5278/BYT-TB-CT (unified English-Vietnamese bilingual). Businesses need to complete this form correctly to avoid document errors.

When carrying out administrative procedures to register for circulation of medical equipment according to the provisions of Decree 36/2016, you must make an online declaration on the Ministry of Health's electronic information portal, called the Online Public Service System for Management of Medical Equipment at the address www.dmec.moh.gov.vn

In the section “Public Services” – “Issuing registration numbers for circulation”, the Ministry of Health has designed two options to distinguish between imported and domestically produced product dossiers. After the above branching step, you will be asked to self-determine which of the following 3 categories the medical equipment you want to register belongs to:

– “There are national standards”: Clause 2, Article 26 of Decree 36 stipulates the procedures for submitting medical equipment with corresponding national technical regulations. Medical equipment of type C and D that penetrate the human body and have a certificate of conformity with a corresponding national technical standard will have their clinical trial requirements reduced. Similarly, medical equipment with in vitro diagnostics of type C and D will be exempted from the requirement for a testing certificate when they have a certificate of conformity with a corresponding national technical standard. However, most medical equipment products are manufactured based on technical standards self-declared by the manufacturer and if there is a CFS (Certificate of Free Sale) from the EU, Japan, Canada, Australia or the United States, they are also exempted from similar documents in the case of such national regulations. Therefore, you should not select this box if it is not related to your product.

– “Is the measuring instrument subject to approval?”: Clause 3, Article 26 of Decree 36/2016 stipulates the procedures to be submitted for medical equipment that is “a measuring instrument that must have its model approved according to the provisions of the law on measurement” different from regular medical equipment. The list of “measuring instruments that must have its model approved” and the sample approval procedure are specified in Circular 23/2013/TT-BKHCN issued by the Ministry of Science and Technology on September 26, 2013, regulating measurement for group 2 measuring instruments. If your medical equipment does not fall into these cases, you should not select this box.

– “Other medical equipment”: This phrase is used to refer to medical equipment that do not have corresponding national technical regulations, are not measuring instruments, or are measuring instruments but do not require sample approval according to the provisions of the law on measurement. Most medical equipment circulating on the market are subject to procedures in this “Other medical equipment” box.

The certificate of quality management standards (abbreviated as ISO) is essentially a proof that the manufacturing plant meets quality standards and the factory has the function of manufacturing registered medical equipment. Currently, ISO 9001 and ISO 13485 are both in effect and the Company can submit one of these two documents to declare or register the product for circulation. However, according to Clause 1, Article 68 of Decree 36/2016, ISO 9001 is only valid until December 31, 2019. From January 1, 2020, medical equipment manufacturing plants must complete the application of ISO 13485 standards. Therefore, MEDNOVUM's view is that the Company should submit the ISO 13485 document so that the Company does not have to spend time and money to re-register the circulation number.

According to Clause 5, Article 22 of Decree 36/2016, only medical equipment owner (not authorized) is authorized to issue a Certificate of Warranty Eligibility according to the form at Appendix VII of Decree 36/2016.

Enterprises importing medical equipment are not allowed to sign a commitment or declare warranty eligibility themselves when preparing a dossier declaring applicable standards.

In case of disposable medical equipment, the requirement for this Certificate of Ownership of the medical equipment is waived, but the importing enterprise must make an Official Dispatch stating "in the case of disposable medical equipment" and submit it to the system in place of this Certificate.

As explained in the Questions about Classification of Medical Equipment, currently, the health sector manages the circulation of medical equipment based on the risk classification of each product. Therefore, incorrect classification results will seriously affect future procedures related to medical equipment. The Ministry of Health/Department of Health still has the right to revoke the issued "Circulation Number" if it discovers that the previously applied standard declaration dossier is not in accordance with regulations and impose administrative sanctions. The consequence may be that the medical equipment must temporarily stop circulating until the enterprise re-registers the "Circulation Number" according to appropriate procedures. This will affect the business activities of the enterprise and the reputation of the brand in the market. In MEDNOVUM's opinion, the Company should send an Official Dispatch requesting the opinion of the Ministry of Health when there are 2 different classification results or carry out the registration procedure for circulation according to the highest risk classification result.

According to Clause 2, Article 40 of Decree 36/2016, medical equipment with a circulation number can be imported in unlimited quantities and does not have to be approved by the Ministry of Health. In this case, your company can import medical equipment (previously registered for a circulation number) without having to re-register the "Circulation Number". The "Circulation Number" for type A medical equipment is valid indefinitely.

No. The applicable standard/Certificate of Conformity is a self-certification that this product meets the production standards. This document is usually presented in the form of DoC (Declare of Conformity) and must be published by the product owner himself (not authorized to another unit). In addition, if the Standard is not in English or Vietnamese, it must be translated into Vietnamese and certified (Clause 2, Article 23, Decree 36/2016).

The certificate of quality management standards (ISO for short) is essentially a proof that the manufacturing plant meets quality standards and that the plant has the function of producing medical equipment registered for circulation. Currently, ISO 9001 and ISO 13485 are both accepted by the Vietnamese Ministry of Health and the Company can submit one of these two documents to declare or register the product for circulation.

However, according to Clause 1, Article 68 of Decree 36/2016, ISO 9001 can only be used until December 31, 2019. From January 1, 2020, when medical equipment manufacturing facilities are required to complete the application of the quality management system according to ISO 13485 standard, the circulation numbers registered with ISO 9001 will have to be re-announced to ensure the obligation to always have a valid ISO during the time the circulation number is valid (point i, Clause 2, Article 66 of Decree 36/2016).

Therefore, MedNovum's view is that if both ISO Certificates are currently available, the Company should submit the ISO 13485 document so that by January 1, 2020, the Company will not have to spend time and money to re-register the circulation number.

According to the provisions of Point d Clause 2 Article 23 Decree 36/2016, the user manual must be submitted in Vietnamese with confirmation from the organization that publishes the applicable standards.

According to MedNovum’s observations, some importers tend to “perform” translations to submit this document at a sketchy summary level or with inaccurate translations. Mednovum recommends that importers use professional and medical translation services to complete the translation of the user manual when submitting it. Because this declaration file exists publicly throughout the life of the device and is a legal reference in the event of a dispute or claim during the consumer’s use.

In compliance with Section a, Clause 5, Article 68 of Decree 36, in 2017, the Ministry of Health only issued import licenses (according to Circular 30) valid until December 31, 2017 for businesses to switch to circulation registration procedures according to Decree 36.

However, on December 6, 2017, the Government issued Resolution No. 131/NQ-CP on postponing the issuance and validity of circulation numbers for medical equipment types B, C, D until January 1, 2019.

Therefore, GPNKs issued in 2017 with a validity period shorter than 12 months can send an official dispatch to the Ministry of Health to request an extension of the validity period to a full 12 months.

Another solution is to apply for a new import license to use until the end of 2018 according to the procedures specified in Circular 30 (for medical equipment of type B, C, D listed in Appendix II of Circular 30).

According to Circular 30, these products do not need to apply for an import license but can be imported and traded as normal goods. In 2018, because the regulations on the classification of medical equipment have come into effect, the customs dossier only needs to include the results of the classification of medical equipment by a competent classification unit in Vietnam or documents proving that the classification results abroad can be recognized in Vietnam according to the provisions of Circular 42/2016.

In fact, the submission of registration dossiers for circulation numbers for medical equipment of type B, C, D has been implemented since July 1, 2017 and has been continuous until now. Resolution 131 of the Government only delays the issuance date and the validity of the registration number, not the start date of receiving registration dossiers. Some of MEDNOVUM's customer enterprises have implemented this in parallel since July 2017 to take advantage of the order of processing dossiers, keep up with the licensing progress and avoid business interruption due to procedural issues.

Currently, MedNovum is aware that some registration dossiers for circulation numbers are not approved by competent authorities simply because the attached documents (authorization letter, technical description document, etc.) are not prepared according to the prescribed form. According to Point c, Clause 2, Article 23 of Decree 36/2016, for imported medical equipment, the owner's authorization letter must be consularly legalized in addition to being legalized. In addition, it should be noted that the English content of the authorization letter must be standardized according to the instructions of the Ministry of Health in Appendix IV issued with Circular 46/2017/TT-BYT.

Article 53 of Decree 36 stipulates that owners of medical equipment are responsible for publicizing information related to the use of medical equipment. Article 54 of Decree 36 stipulates that the label of medical equipment must have instructions for looking up information on instructions for use of medical equipment.

Thus, compared to previous regulations, the user manual must be made public and can be consulted when necessary during the circulation of medical equipment for Vietnamese users. However, because the user manual is often quite long and the size of the product label is often limited, the manufacturer or importer cannot present this part on the label. To comply, MEDNOVUM often advises customers to translate the main part of the user manual for medical equipment and post it publicly on a business's electronic information page (website). On the product label, there will be a link to that website for users to access when necessary.

Except for (1) medical equipment that has a CFS from recognized developed countries and (B) goods manufactured or processed for export that do not require clinical trials in the destination country, the Ministry of Health also issues a list of medical equipment of type C and D that penetrate the human body but do not require clinical trial documents in Appendix I of Circular 46/2017/TT-BYT.

From July 1, 2016, companies operating in the medical equipment business must simultaneously satisfy the following two requirements:

1. In the business registration procedure, the Company registered the business code number 4659 “Wholesale of medical machinery and equipment” and/or number 4772 “Retail sale of medicines, medical equipment, cosmetics and toiletries in specialized stores”"; and
2. The company must meet all the conditions stipulated in Decree 36/2016: A team of staff with technical or medical qualifications, suitable storage and transportation facilities or a contract with a facility with sufficient storage and transportation capacity. The procedure for declaring eligibility to buy and sell medical equipment is carried out through the Ministry of Health's electronic information portal.

Note: The announcement of qualified establishments for trading in medical equipment currently applies to establishments trading in medical equipment of type B, C, D. Therefore, if your company only specializes in trading in medical equipment of type A, it is not necessary to carry out this procedure. However, the company must still meet the conditions for adding the business line of trading in medical equipment on the Business Registration Certificate.

According to the provisions of Decree 36/2016/ND-CP, the conditions for qualified personnel are: “College degree in engineering or medicine, pharmacy or medical equipment engineering or higher, or college degree or higher with a major suitable for the type of medical equipment that the establishment is trading in” is defined as a person with an Engineering Degree and is shown to be Engineering Degree but not Bachelor's Degree. Thus, the Company's current staff are not qualified as appropriately qualified technical staff to perform installation and instruction for the type of medical equipment that the facility purchases and sells.

According to Article 37 and Clause 3, Article 13 of Decree 36/2016/ND-CP, medical equipment trading establishments must have warehouses and facilities that meet the following conditions:

– Have an area suitable for the type and quantity of medical equipment stored;

– Ensure ventilation, dry, clean, away from sources of pollution;

– Meet other storage requirements of medical equipment according to the instructions for use.

– The means of transporting medical equipment from the manufacturing facility to the delivery location shall be appropriate to the type of medical equipment the facility produces.

Accordingly, the law does not specifically regulate the area of the warehouse or the form of means of transport.

However, the factory must be suitable for the purpose of preserving medical equipment, for example: apartment buildings (by law) are used for the sole purpose of residence so they cannot be used as warehouses; the area must be large enough when preserving large-scale medical equipment or factors such as temperature, humidity, etc. For means of transport, the purpose must be to transport goods and cannot be cars used to carry people.

In case the facility does not have a warehouse and means of transporting medical equipment, it must have a contract with a facility that meets the requirements for warehouse and transporting medical equipment according to the above regulations.

According to the principles of medical equipment management, the facility that carries out the announcement of related procedures is obliged to ensure that the information in the attached documents is always accurate and valid. Therefore, your Company is required to re-conduct the procedure of announcing eligibility to buy and sell medical equipment when there is a change in personnel/warehouse/means of transporting medical equipment, not just submitting an Official Dispatch/Notification to supplement/adjust that change (Clause 4, Article 38, Decree 36/2016).

Clause 2, Article 39 stipulates that business establishments do not have to meet the conditions in Article 37 of Decree 36/2017 and do not have to declare eligibility to buy and sell when trading in medical equipment of types B, C, D in the list of medical equipment issued by the Minister of Health in Appendix III of Circular 46/2017/TT-BYT dated December 15, 2017.

The Ministry of Health's electronic information portal currently does not have a function that allows businesses to cancel their published records on their own. Based on Mednovum's experience, we recommend that you submit a document requesting to revoke the issued publication number with the reason: "errors in the published records" to the Department of Health of the province where the headquarters is located. After that, the Department of Health will issue a Post-Inspection Form, evaluate the unqualified records and cancel the published number posted on the System. At this point, the business can resubmit a new publication record to replace it.

After consulting and reviewing the registration documents on the website http://dmec.moh.gov.vn/trangchu, MedNovum found that organizations and establishments that announce applicable standards/register circulation numbers often make some mistakes as stipulated in Decree 36/2016 as follows:

1. Documents such as Power of Attorney, Warranty Eligibility Certificate, Technical Summary Description Document are not prepared in the prescribed form;
2. Documents such as Power of Attorney and Certificate of Conformity issued by foreign agencies are not eligible for use in Vietnam (not consular legalized, not translated into Vietnamese if the content is not in English or Vietnamese);
3. Documents no longer valid at the time of registration: Certificate of Free Sale (CFS) and Certificate of Conformity (ISO) are valid for 03 years from the date of issue, consularly legalized documents are valid for 03 months from the date of certification;
4. Organizations that register for circulation do not supplement or re-register for circulation when the initial registration information changes (warranty facility, owner of medical equipment...);
5. The user manual is not translated into Vietnamese; or
6. The label does not contain full information according to regulations on medical equipment labels.

Decree 36/2016 stipulates cases of revocation of circulation numbers, including: voluntary revocation; falsification of registration documents; 3 batches forced to suspend circulation; corrections and erasures that change the content of the circulation number; the enterprise closes/is no longer authorized by the owner of the medical equipment; medical equipment does not ensure quality; the circulation number is issued without proper authority, documents, or procedures; the circulation period has expired; the manufacturing facility does not meet the prescribed conditions and the case of loss of the original documents used for registration.

According to the provisions of Clause 4, Article 36 of Decree 36/2016, once the circulation number is revoked, the medical equipment related to the circulation number, whether imported, wholesaled or retailed to consumers, must be revoked. The relevant agencies will supervise the recall.