Chương V Nghị định 98/2021/NĐ-CP: Lưu hành trang thiết bị y tế

Chapter V

PLACEMENT OF MEDICAL DEVICES ON MARKET

Section 1. REGISTRATION NUMBER, CONDITIONS FOR PLACEMENT ON THE MARKET AND REQUIREMENTS FOR ORGANIZATIONS DECLARING APPLIED STANDARDS OR APPLYING FOR REGISTRATION NUMBER

Article 21. Registration number of medical devices

1. Registration number of a medical device is:

a) The number of declaration of applied standards of Class-A or Class-B medical device;

b) The number of certificate of registration of Class-C or Class-D medical device.

2. Registration number holder is the organization that declares applied standards for Class-A or Class-B medical device or that is granted certificate of registration of Class-C or Class-D medical device.

3. Validity of registration number: The medical device registration number shall be valid for indefinite term, except cases where a registration number is issued according to regulations on issuance of emergency use registration number for medical devices to serve epidemic prevention and control, and disaster recovery purposes. Based on the application for issuance of emergency use registration number for the medical device, the Minister of Health shall decide specific period validity of the issued registration number.

Article 22. Conditions for placement of medical devices on the market

1. A medical device may be placed on the market if it meets the following conditions:

a) It has been granted registration number or import license in accordance with regulations laid down in this Decree, except the cases specified in Clause 8 Article 3 and Article 24 of this Decree;

b) Its label contains adequate information in accordance with regulations of law on labeling of goods;

c) Instructions for use of the medical device are given in Vietnamese;

d) Information about warranty center, conditions and time for warranty, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty.

2. If the information specified in Point c and Point d Clause 1 of this Article is not provided upon the medical device itself, it must be provided in the form of electronic information for which instructions for search must be available on the label of the medical device.

Article 23. Requirements for declaration of applied standards or issuance of certificate of registration for medical devices

1. Requirements for declaration of applied standards or issuance of certificate of registration for medical devices:

a) The medical device is manufactured domestically by a manufacturer that has made declaration of eligibility for manufacture of medical devices;

b) If the medical device is imported, it has been manufactured by a manufacturer that is granted certificate of conformity with ISO 13485 quality control standards, and permitted to be sold in every country in the world;

c) The medical device comply with national technical regulations or standards declared by the manufacturer.

2. Applications for declaration of applied standards or registration of medical devices shall be rejected in the following cases:

a) The medical device falls in the case specified in Clause 1 Article 37 of this Decree;

b) The medical device is recalled under Clauses 1, 3 Article 38 of this Decree.

3. If a medical device registration number is revoked under Clause 2 Article 38 of this Decree, an application for declaration of applied standards or registration of that medical device submitted within 12 months from the date of the revocation decision shall be rejected.

Article 24. Cases of exemption from requirements for declaration of applied standards and registration

1. The medical device is used for research, testing, inspection, experiment, performance evaluation, instruction for use or device modification only.

2. The medical device is imported into Vietnam to serve the purposes of emergency aid or provision of humanitarian medical services or display at trade fair, exhibition or product launch event or use as gift given to a health facility or for medical treatment of a particular individual or to serve special diagnosis of a health facility.

3. Unregistered medical devices are imported to serve epidemic prevention and control, disaster recovery and cannot be replaced by any other medical devices sold on the market.

4. Medical devices are manufactured in Vietnam to serve the purposes of export or display at an overseas trade fair or exhibition only.

Article 25. Requirements for organizations declaring applied standards or applying for registration number for medical devices

1. Organizations that declare applied standards or apply for registration number for medical devices include:

a) Vietnamese enterprises, cooperatives or household businesses that are product owners;

b) Vietnamese enterprises, cooperatives or household businesses that are authorized by product owners;

c) Permanent representative offices in Vietnam of foreign traders that are product owners or authorized by product owners.

2. The organization declaring applied standards or applying for registration of a medical device must establish and maintain a warranty center in Vietnam or sign a contract with a qualified warranty center, except disposable medical devices as defined by product owners or cases where there are documents proving that the medical device is not under warranty.

Where the organization declaring applied standards or applying for registration of a medical device is the entity prescribed in Point c Clause 1 of this Article, the product owner must establish and maintain a warranty center in Vietnam or sign a contract with a qualified warranty center, except disposable medical devices as defined by product owners or cases where there are documents proving that the medical device is not under warranty.

The warranty center must be granted certificate of eligibility to provide warranty by the product owner.

Section 2. DECLARATION OF APPLIED STANDARDS FOR CLASS-A OR CLASS-B MEDICAL DEVICES

Article 26. Application for declaration of applied standards

An application for declaration of applied standards for Class-A or Class-B medical device consists of:

1. The declaration of applied standards for Class-A or Class-B medical device.

2. An unexpired certificate of conformity with ISO 13485 quality control standards.

3. The unexpired letter of authorization given by the product owner to the organization that applies for declaration of applied standards, except the case specified in Point a Clause 1 Article 25 of this Decree.

4. The certificate of eligibility to provide warranty services granted by the product owner, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty.

5. A synopsis of technical description of the medical device in Vietnamese, accompanied by technical documents describing functions and specifications of the medical device issued by the product owner.

With regard to in-vitro reagents, calibrators and control materials, the synopsis of technical description in Vietnamese must be accompanied by documents on materials and safety of the product, manufacturing process, pre-clinical and clinical study reports including stability report.

6. The certificate of conformity or product standard sheet provided by the product owner.

With regard to domestically manufactured medical devices, the assessment record of chemical, physical and microbiological indicators and other indicators provided by a qualified conformity assessment body in accordance with regulations of law on conformity assessment is required; if it is an IVD medical device, certificate of quality assessment issued by a competent authority of Vietnam is required. The assessment result must be conformable with the standards declared by the product owner.

7. User manual of the medical device.

8. A sample of the label for the medical device sold in Vietnam.

9. The unexpired CFS (for imported medical devices).

Article 27. Requirements for application for declaration of applied standards

1. 01 set of application for declaration of applied standards shall be prepared.

2. Requirements for some documents included in the application:

a) Certificate of conformity with quality control standards: original copy or certified true copy or copy bearing certification of the declarant.

If the Certificate of conformity with quality control standards is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

b) Product owner’s letter of authorization and certificate of eligibility to provide warranty:

- For a domestically manufactured medical device: original copy or certified true copy;

- For an imported medical device: consularly legalized copy or certified true copy thereof.

c) Certificate of conformity or product standard sheet provided by the product owner: original copy or copy bearing certification of the declarant.

If the product standard sheet is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

d) User manual of the medical device: Vietnamese copy bearing certification of the declarant, accompanied by English version issued by the product owner, in case of imported medical devices. If the user manual is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

dd) Sample label: the sample label bearing certification of the declarant. The sample label must meet requirements laid down in regulations of law on labeling of goods.

e) CFS: consularly legalized copy or certified true copy thereof.

If the CFS is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

g) Record of chemical, physical and microbiological indicators and other indicators provided by a qualified conformity assessment body in accordance with regulations of law on conformity assessment or certificate of quality assessment issued by regulatory authority of Vietnam (for an IVD medical device): original copy or certified true copy.

Article 28. Procedures for declaration of applied standards

1. Before placing Class-A or Class-B medical device on the market, the organization declaring applied standards (declarant) shall submit an application for declaration to the Department of Health of province where it is headquartered.

2. After receiving the application (including application fee receipt as prescribed by the Ministry of Finance), the Department of Health of province where the declarant is headquartered shall publish the number of declaration of applied standards for Class-A or Class-B medical device on the Portal on management of medical devices and applications for declaration of applied standards, except the documents specified in Clause 5 Article 26 of this Decree.

3. In case of changes in the product owner, class of the medical device, category, intended purposes or indications for use of the medical device, or provision of additional information about the manufacturer or product code, the registration number holder shall reapply for declaration of applied standards in accordance with regulations of this Decree.

4. During the placement of the medical device on the market, the product owner that has declared applied standards for the medical device shall prepare written notice of changes, accompanied by supporting documents, and update them to its application for declaration of applied standards published on the Portal on management of medical devices within 05 working days from the occurrence of any of the following changes:

a) Change in address of the product owner or registration number holder;

b) Change in name of the registration number holder or product owner;

c) Change in the medical device manufacturer’s name or address;

d) Change in packaging specifications;

dd) Change in the warranty center;

e) Change in the label or user manual without changing intended purposes or indications for use. Where the medical device has been manufactured before the product owner makes a notice of change in the label, the device may be placed on the market with the information declared at the date of manufacture;

g) Reduction of factories, category or product code.

Section 3. REGISTRATION OF CLASS-C OR CLASS-D MEDICAL DEVICES

Article 29. Methods of registration

1. A new registration number shall be issued in the following cases:

a) The medical device does not have any registration number.

b) The medical device has been granted registration number but has any of the following changes:

- A change in the product owner; class of the medical device; category, intended purposes or indications for use; quality standards; addition of factory or product code; raw materials that affect the functions of IVD medical device or disposable medical device; concentration, content, composition of raw materials that are active ingredients incorporated in the medical device to support in medical treatment;

- A change other than those specified in Clause 7 Article 32 of this Decree.

2. Cases of quick issuance of a new registration number:

a) The medical device has been granted the CFS (Certificate of Free Sale) or marketing authorization by one of the following authorities or countries: U.S. Food and Drug Administration (FDA), Australian Therapeutic Goods Administration (TGA), Health Canada, Japanese Ministry of Health, Labour and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency, EU state members, UK, Switzerland, National Medical Products Administration (NMPA) - China, Ministry of Food & Drug Safety (MFDS) - Korea, or other CFS issuing authorities recognized by Vietnam (hereinafter referred to as “reference countries”);

b) The medical device has been granted the import license or registration number or certificate of registration in the commercial form in Vietnam, unless revoked before the effective date of this Decree;

3. Issuance of emergency use registration number for medical devices to serve epidemic prevention and control, and disaster recovery purposes in emergency cases included in the relevant List issued by the Minister of Health and in one of the following cases:

a) The medical device has been placed on the market or granted registration number for emergency use in one of the reference countries;

b) The medical device is included in the list of products for emergency use announced by the World Health Organization (WHO);

c) The medical device is included in the list of common products announced by the EU Health Security Committee (EUHSC);

d) The medical device has been granted the registration number or import license in the commercial form in Vietnam, unless revoked before the effective date of this Decree;

dd) The medical device is domestically manufactured in the form of technology transfer in one of the cases specified in Points a, b, c or d of this Clause;

e) The medical device is domestically manufactured in the form of processing in one of the cases specified in Points a, b, c or d of this Clause.

Article 30. Application for issuance of a new registration number

1. An application for issuance of a new registration number of a medical device without a national technical regulation consists of:

a) The application form for issuance of a new registration number.

b) An unexpired certificate of conformity with ISO 13845 quality control standards.

c) The unexpired letter of authorization given by the product owner to the organization that applies for registration, except the case specified in Point a Clause 1 Article 25 of this Decree.

d) The certificate of eligibility to provide warranty granted by the product owner, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty.

dd) The unexpired CFS (for imported medical devices).

e) ASEAN Common Submission Dossier Template (hereinafter referred to as “CSDT”).

g) Certificate of conformity.

2. An application for issuance of a new registration number for the medical device that is a measuring device whose sample requires approval as prescribed by the law on measurement consists of:

a) The application form for issuance of a new registration number.

b) Decision on approval of the sample medical device.

c) The documents specified in Points b, c, d, dd and e Clause 1 of this Article.

3. An application for quick issuance of a new registration number for the medical device as prescribed in Clause 2 Article 29 of this Decree consists of:

a) The application form for issuance of a new registration number.

b) The documents specified in Points b, c, and d Clause 1 of this Article.

c) The CFS issued by one of the reference countries in the case prescribed in Point a Clause 2 Article 29 of this Decree.

d) The CFS of the imported medical device and import license or registration number or certificate of registration in the case prescribed in Point b Clause 2 Article 29 of this Decree.

dd) Certificate of quality assessment issued by a competent authority of Vietnam for IVD medical device, except the following cases:

- The medical device is included in List A or List B of Annex 2 of the European Union Regulation of In Vitro Diagnostic Medical Devices and has been granted CFS by one of EU Member States, UK or Switzerland;

- The medical device is included in List A or List B of Annex 2 of the European Union Regulation of In Vitro Diagnostic Medical Devices and has been granted the Marketing Authorization by one of the reference countries;

- The medical device is not included in List A or List B of Annex 2 of the European Union Regulation of In Vitro Diagnostic Medical Devices but has been granted the Marketing Authorization by one of the reference countries;

- The medical device is included in the list of medical devices announced by the Minister of Health.

e) The CSDT.

4. An application for issuance of a new registration number for the medical device in an emergency case prescribed in Clause 3 Article 29 of this Decree consists of:

a) The application form for issuance of a new registration number.

b) The documents specified in Points b, c, and d Clause 1 of this Article.

c) The CFS or license for emergency use of the imported medical device.

d) The contract for technology transfer in the case prescribed in Point dd Clause 3 Article 29 of this Decree.

dd) The processing contract in the case prescribed in Point e Clause 3 Article 29 of this Decree.

e) Certificate of inspection or certificate of quality assessment issued by one of the inspection/assessment bodies in the list published on the Ministry of Health’s website if the medical device falls in one of the following cases:

- a) The medical device is domestically manufactured;

- The medical device has been granted permit for placement on the market or emergency use by a competent authority of one of EU Member States, UK or Switzerland but is not included in the EUHSC’s list of common products.

g) The CSDT.

5. An application for issuance of a new registration number for another medical device consists of:

a) The application form for issuance of a new registration number.

b) The documents specified in Points b, c, d and dd Clause 1 of this Article.

c) The CSDT inspection record given by the authority designated by the Minister of Health, accompanied by the CSDT.

d) With regard to IVD medical device that is reagent, calibrator or control material: certificate of quality issued by a competent authority of Vietnam.

dd) With regard to chemicals or preparations only used for disinfection of medical devices: Report on testing for active ingredients for disinfection given by the entity that has declared its eligibility to provide testing services in accordance with regulations of law on management of insecticidal and germicidal chemicals and preparations for medical and household use; report on trials to evaluate biological efficacy and side effects of product on trial participants given by the entity that has declared its eligibility to conduct trial in accordance with regulations of law on management of insecticidal and germicidal chemicals and preparations for medical and household use.

Article 31. Requirements for application for issuance of a new registration number

1. Requirements for some documents included in the application for registration:

a) Certificate of conformity with quality control standards: original copy or certified true copy or copy bearing the applicant’s certification.

If the Certificate of conformity with quality control standards is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

b) Product owner’s letter of authorization and certificate of eligibility to provide warranty:

- For a domestically manufactured medical device: original copy or certified true copy;

- For an imported medical device: consularly legalized copy or certified true copy thereof.

c) CFS: consularly legalized copy or certified true copy thereof.

If the CFS is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

d) Certificate of quality assessment, testing report, trial report and CSDT inspection record: original copy or certified true copy or copy bearing the applicant’s certification.

dd) CSDT: copy bearing the applicant’s certification. If the CSDT is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

2. Requirements for some documents included in an application for registration of medical device for emergency use as prescribed in Clause 3 Article 29 of this Decree:

Documents issued by foreign competent authorities must be consularly legalized. Where a document does not bear consular legalization:

a) With regard to the letter of authorization: its original copy accompanied by certification shall be submitted.

b) With regard to the document specified in Point c Clause 4 Article 30 of this Decree: it must indicate the link for searching information on placement on the market or license for use of the medical device on the licensing authority’s website and be accompanied by a document providing the link for searching information of the applicant. Information on placement of the device on the market found on the website must include at least the following information in English: name, category, manufacturer and manufacturing country.

Article 32. Receipt and processing of application for registration of medical devices

1. The applicant shall submit an application for registration number to the Ministry of Health through the Portal on management of medical devices.

2. With regard to an application for registration number for the medical device in the case prescribed in Clause 1 or Clause 2 Article 30 of this Decree:

a) If the application is satisfactory, the Minister of Health shall process it within 30 days from the receipt of the adequate and valid application (including the application fee receipt as prescribed by the Ministry of Finance). If an application is refused, a written response indicating reasons for such refusal shall be provided.

b) If the application is not satisfactory, the Ministry of Health shall send a request for modification, in which such documents and contents requiring modification must be specified, to the applicant within 25 days from the receipt of the application.

c) The applicant shall comply with the request for modification and send modified documents to the Ministry of Health as requested.

If the modified application is still unsatisfactory, the Ministry of Health shall continue sending a request for modification to the applicant as prescribed in Point b Clause 2 of this Article.

If the applicant fails to provide the modified application within 90 days from the receipt of the Ministry of Health’s request for modification or the application is still unsatisfactory after 05 modification times, the application shall be rejected.

3. With regard to an application for registration number for the medical device in the case prescribed in Clause 3 Article 30 of this Decree:

a) If the application is satisfactory, the Minister of Health shall process it within 10 days from the receipt of the adequate and valid application (including the application fee receipt as prescribed by the Ministry of Finance). If an application is refused, a written response indicating reasons for such refusal shall be provided.

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. The applicant shall assume responsibility for the accuracy and legitimacy of other documents included in the application which may be inspected by the Ministry of Health after issuing the registration number.

b) If the application for registration number is not satisfactory, the Ministry of Health shall send a request for modification, in which such documents and contents requiring modification must be specified, to the applicant within 10 days from the receipt of the application.

c) The applicant shall comply with the request for modification and send modified documents to the Ministry of Health as requested.

If the modified application is still unsatisfactory, the Ministry of Health shall continue sending another request for modification to the applicant as prescribed in Point b Clause 3 of this Article.

If the applicant fails to provide the modified application within 90 days from the receipt of the Ministry of Health’s request for modification or the application is still unsatisfactory after 05 modification times, the application shall be rejected.

4. With regard to an application for registration number for the medical device in the case prescribed in Clause 4 Article 30 of this Decree:

a) If the application is satisfactory, the Minister of Health shall process it within 10 days from the receipt of the adequate and valid application (including the application fee receipt as prescribed by the Ministry of Finance). If an application is refused, a written response indicating reasons for such refusal shall be provided.

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. The applicant shall assume responsibility for the accuracy and legitimacy of other documents included in the application which may be inspected by the Ministry of Health after issuing the registration number.

b) If the application for registration number is not satisfactory, the Ministry of Health shall send a request for modification, in which such documents and contents requiring modification must be specified, to the applicant within 08 days from the receipt of the application.

c) The applicant shall comply with the request for modification and send modified documents to the Ministry of Health as requested.

If the modified application is still unsatisfactory, the Ministry of Health shall continue sending another request for modification to the applicant as prescribed in Point b Clause 4 of this Article.

If the applicant fails to provide the modified application within 90 days from the receipt of the Ministry of Health’s request for modification, the application shall be rejected.

5. With regard to an application for registration number for the medical device in the case prescribed in Clause 5 Article 30 of this Decree:

a) If the application is satisfactory, the Minister of Health shall process it within 45 days from the receipt of the adequate and valid application (including the application fee receipt as prescribed by the Ministry of Finance). If an application is refused, a written response indicating reasons for such refusal shall be provided.

b) If the application for registration number is not satisfactory, the Ministry of Health shall send a request for modification, in which such documents and contents requiring modification must be specified, to the applicant within 40 days from the receipt of the application.

c) The applicant shall comply with the request for modification and send modified documents to the Ministry of Health as requested.

If the modified application is still unsatisfactory, the Ministry of Health shall continue sending another request for modification to the applicant as prescribed in Point b Clause 5 of this Article.

If the applicant fails to provide the modified application within 90 days from the receipt of the Ministry of Health’s request for modification or the application is still unsatisfactory after 05 modification times, the application shall be rejected.

6. Within 01 working day from the issuance of the registration number, the Ministry of Health shall publish the following information on the Portal on management of medical devices, including:

a) Name, category, manufacturer and manufacturing country of the medical device;

b) Registration number of the medical device;

c) Name and address of the product owner;

d) Name and address of the registration number holder;

dd) Name and address of the warranty center;

e) The documents included in the application for registration of the medical device, except the documents specified in Point e Clause 1 and Point c Clause 5 of Article 30;

g) Intended purposes of the medical device.

7. During the placement of the medical device on the market, the registration number holder shall prepare written notice of changes, accompanied by supporting documents, and update them to its application for registration number published on the Portal on management of medical devices within 10 working days from the occurrence of any of the following changes:

a) Change in address of the product owner or registration number holder;

b) Change in name of the registration number holder or product owner;

c) Change in the medical device manufacturer’s name or address;

d) Change in packaging specifications;

dd) Change in the warranty center;

e) Change in the label or user manual without changing intended purposes, indications for use, functions or performance of the medical device. Where the medical device has been manufactured before the registration number holder makes a notice of change in the label, the device may be placed on the market with information registered and updated at the date of manufacture.

Section 4. POST-MARKET MANAGEMENT OF MEDICAL DEVICES AND HANDLING OF MEDICAL DEVICES IN SOME SPECIFIC CASES

Article 33. Documents for post-market management of medical devices

The registration number holder shall organize and manage the tracing of origin of medical devices placed on the market and fully retain at least the following documents to serve its management of medical devices:

1. The application for issuance of registration number for medical device of which the following documents shall be retained in physical form:

a) The letter of authorization given by the product owner to the organization that applies for registration, except the case specified in Point a Clause 1 Article 25 of this Decree;

b) The certificate of eligibility to provide warranty granted by the product owner, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty;

c) The CFS or marketing authorization.

2. Distribution records (if the registration number holder is a representative office, it shall not be required to retain these records but must request the entity that it authorizes to import the medical device to perform this responsibility).

3. Records of adverse events, complaints and corrective actions that indicate name, category, quantity and batch number of the medical device, especially those that are defective or unsafe for users.

4. Medical device quality management documents, including:

a) The Certificate of Origin made in accordance with regulations of law on origin of goods;

b) The certificate of quality of each medical device batch issued by the product owner or manufacturer whose name is specified in the application for registration of the medical device;

c) Record of inspection of medical device in the case specified in Clause 1 Article 55 of this Decree;

d) Technical documents serving the repair and maintenance of the medical device, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty;

dd) Instructions for use of the medical device are given in Vietnamese;

e) Information about warranty center, conditions and time for warranty, except disposable medical devices defined by the product owner or cases where there are documents proving that the medical device is not under warranty.

Article 34. Handling of medical devices that pose a serious threat to public health or may cause death of users

1. In case where a Vietnamese or international competent authority issues a warning against a medical device that poses a serious threat to public health or may cause death of users, the registration number holder shall inform health facilities using such device of the warning and carry out investigations within 30 days from the receipt of such warning. If the investigation cannot be finished within 30 days, a report specifying reasons and solutions for ensuring safety of users shall be submitted to the Ministry of Health.

2. In case the medical device specified in Clause 1 of this Article is found to have a defect which may affect the health of users, the registration number holder shall:

a) Suspend the placement of the batch of medical devices on the market.

b) Send a written notice to the Ministry of Health, distributors and users of such medical device. The notice shall specify the batch number and the defect, and whether or not such defect can be repaired.

c) Establish a plan for repairing or recalling the batch of defective medical device.

d) Send a report to the Ministry of Health after the repair or recall of defective medical devices is completed.

3. If the defect can be repaired:

a) Within 03 working days from the receipt of the notice from the registration number holder, the Ministry of Health shall issue a decision to suspend the placement of the batch of defective medical devices on the market.

A suspension decision shall contain the following information:

- Name of the medical device suspended from placement on the market;

- Batch number of the medical device;

- Registration number of the medical device.

b) After a suspension decision is issued, the registration number holder shall repair the defect, which causes adverse effects to the health of users.

c) After completing the repair of the defect, the registration number holder shall send a report accompanied by the inspection record (for the medical device specified in Clause 1 Article 55 of this Decree) or commitment to maintain quality of the medical device after the defect has been repaired (for other medical device) to the Ministry of Health.

d) Within 20 working days from the receipt of the report for the registration number holder, the Ministry of Health shall issue a decision to lift the suspension. If the Ministry of Health refuses to lift the suspension, it shall respond and explain in writing.

4. If the defect cannot be repaired:

a) The Ministry of Health shall issue a decision to recall the entire batch of defective medical devices.

A recall decision shall contain the following information:

- Name of the medical device to be recalled;

- Batch number;

- Registration number of the medical device.

b) The registration number holder shall recall the entire batch of defective medical devices by the deadline imposed by a competent authority and pay the cost of recall.

c) If the registration number holder fails to complete the recall by the deadline imposed by the competent authority, the recall will be enforced in accordance with regulations of law on handling of administrative violations.

Article 35. Actions to be taken in case of an adverse event (AE) that has caused harm to health of users

1. In case where a medical device has an AE that pose a serious threat to public health or has caused death of a user, the registration number holder shall:

a) Post a notice of the AE on the registration number holder’s website (if any) and send written notices of the AE to the Ministry of Health, traders and users of that batch of medical devices;

b) Suspend the placement on the market of the batch of medical devices involving the AE;

c) Initiate an investigation into the causes of the AE;

d) Send a report to the Ministry of Health after the investigation result is available. If the AE is caused by a defect in the medical device, the report shall describe the defect and whether it can be repaired. Carry out repair of the defect or recall of the batch of defective medical devices, submit a report to the Ministry of Health after completing the repair or recall.

2. In case the AE does not cause death but has caused serious harm to the health of users, the registration number holder shall:

a) Send a notice of the AE to the Ministry of Health;

b) Initiate an investigation into the causes of the AE;

c) Send a report to the Ministry of Health after the investigation result is available. If the AE is caused by a defect in the medical device, the report shall describe the defect and whether it can be repaired. Carry out repair of the defect or recall of the batch of defective medical devices, submit a report to the Ministry of Health after completing the repair or recall.

3. The medical device that has a defect that causes harm to health of users shall be handled in accordance with Clause 3 and Clause 4 Article 34 of this Decree.

Article 36. Handling, repair and recall of defective medical devices

1. Methods for handling defective medical devices:

a) Providing instructions on how to fix the defect;

b) Fixing the defect;

c) Replace the defective medical device with an equivalent device;

d) Recall the defective medical device for re-export or destruction;

2. Methods for recall of the defective medical devices:

a) Voluntary recall by the registration number holder;

b) Mandatory recall in the cases specified in Article 39 of this Decree.

Article 37. Handling of medical devices in case product owner or registration number holder no longer carries out manufacturing or goes bankrupt or is dissolved

1. If the product owner declares termination of manufacturing of a medical device which has been granted the registration number or goes bankrupt or is dissolved, the medical device may be placed on the market for a maximum period of 24 months from the date of the product owner’s declaration of manufacturing termination, bankruptcy or dissolution provided that the registration number holder in Vietnam provides a commitment to provide warranty or materials for replacing or serving the use of the medical device for 08 years, unless the registration number holder is a permanent representative office in Vietnam of a foreign trader that is the product owner.

2. If the registration number holder of a medical device goes bankrupt or is dissolved, the medical device may be placed on the market for a maximum period of 24 months from the date of the registration number holder’s declaration of bankruptcy or dissolution provided that the distributor provides a commitment to provide warranty or materials for replacing or serving the use of the medical device for 08 years.

3. The registration number holder or distributor shall send their commitments to the Ministry of Health through the Portal on management of medical devices within 60 days from the day on which the product owner or registration number holder declares termination of manufacturing or goes bankrupt or is dissolved.

4. The commitment shall include the following documents:

a) The written commitment to provide warranty and materials serving the use of the medical devices;

b) The list of medical devices of which it is the registration number holder but the product owner or registration number holder declares termination of manufacturing or goes bankrupt or is dissolved.

5. Within 15 working days from the receipt of the commitment as prescribed in Clause 4 of this Article, the Ministry of Health shall give a written response indicating whether or not the medical device may be placed on the market. If the placement of the medical device on the market is not approved, reasons for such refusal shall be given.

6. If the Ministry of Health refuses to permit the placement of the medical device specified in Clause 1 of this Article on the market, the registration number holder or distributor shall recall all medical devices placed on the market, except those sold to users.

Section 5. REVOCATION OF REGISTRATION NUMBER OF MEDICAL DEVICES

Article 38. Cases where registration number is revoked

1. The application for registration number is forged.

2. In case where 03 batches of the medical device are recalled during the validity of the registration number, except registration number holder’s voluntary recall of the medical device.

3. The applicant deliberately alters or erasures the contents of the registration number.

4. The registration number holder shuts down or is no longer authorized by the product owner and no substitute is appointed, except the case specified in Article 37 of this Decree.

5. Quality of the medical device placed on the market is not consistent with the registered quality.

6. The registration number has been issued against regulations of this Decree.

7. The registration number holder or distributor has not provided commitment for the medical device as prescribed in Clause 1 and Clause 2 Article 37 of this Decree.

8. The period for placing the medical device on the market expires as prescribed in Clause 1 or Clause 2 Article 37 of this Decree.

9. The medical device has been manufactured at a factory that fails to satisfy eligibility requirements laid down in this Decree.

10. The registration number holder fails to comply with the provision of Point k Clause 3 Article 74 of this Decree, except the case specified in Article 37 of this Decree.

11. The application for declaration or issuance of registration number is found to not comply with regulations of this Decree.

12. The medical device has been classified against regulations on classification of medical devices.

13. The registration number holder applies for voluntary revocation of the registration number.

Article 39. Procedures for revocation of registration number

1. If any of the cases specified in Clauses 1 through 12 Article 38 of this Decree is discovered during the inspection, the inspecting agency shall prepare and send an inspection record to the Ministry of Health or Provincial Department of Health that has issued the registration number (hereinafter referred to as “registration number issuer”).

2. Within 05 working days from the receipt of the inspection record specified in Clause 1 of this Article, the registration number issuer shall consider issuing a decision to revoke registration number under their management.

3. After issuing the decision to revoke registration number, the registration number issuer shall:

a) Publish the decision to revoke registration number on its website and send it to the registration number holder, Ministry of Health, Provincial Departments of Health and customs authorities.

b) Remove all information related to the medical device published on its website.

4. When receiving the decision to revoke registration number of the registration number issuer, Provincial Departments of Health shall publish the full text of the decision on their websites and direct specialized agencies to supervise the recall of relevant medical devices.

5. Where the registration number holder applies for revocation of registration number, an application indicating reasons for such revocation shall be submitted to the registration number issuer. After receiving the application, the registration number issuer shall carry out procedures for revocation of registration number as prescribed in Clause 2 and Clause 3 of this Article.

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