Decree No. 36/2016/ND-CP On Medical Equipment Management

PART I
GENERAL PROVISIONS

 

Article 1. Scope of Regulation

This Decree stipulates the management of medical devices including: classification of medical devices; production, circulation, purchase and sale, provision of medical device services; information and labeling of medical devices and management and use of medical devices at healthcare facilities.

Article 2. Interpretation of Terms

1. Medical devices are types of equipment, tools, materials, implantable materials, in vitro diagnostic reagents and calibrators, software used individually or in combination according to the owner's instructions for medical devices to serve humans for one or more of the following purposes:

a) Diagnosis, prevention, monitoring, treatment, and alleviation of diseases or compensation for injuries or trauma;

b) Examination, replacement, adjustment, or support for anatomical and physiological processes;

c) Support or maintenance of life;

d) Control of conception;

đ) Disinfection of medical devices, including chemicals used in testing procedures;

e) Special transportation or use for medical activities;

g) Provision of information for diagnosis, monitoring, and treatment through examination of samples originating from the human body.

2. In vitro diagnostic medical devices include reagents, calibrators, control materials, tools, machines, equipment, or systems used individually or in combination according to the owner's instructions to serve the examination of samples originating from the human body.

3. Accessories are products designated by the owner of medical devices for specific purposes together with a specific medical device to facilitate or support its intended use.

4. The owner of medical devices is an organization or individual who performs the following:

a) Supplying medical devices under their own name or by any trademark, design, trade name, or other name or code owned or controlled by that individual or organization;

b) Being responsible for the design, production, assembly, processing, labeling, packaging, or repair of medical devices or determining the purpose of use of those medical devices.

Article 3. Principles of medical device management

1. Ensuring quality, safety, and effective use of medical devices.

2. Providing full, accurate, and timely information about the technical characteristics, functions of medical devices, and potential risk factors for users.

3. Ensuring traceability of the origin of medical devices.

4. Management of medical devices must be based on risk classification and corresponding national standards and technical regulations issued, recognized, or announced for application by organizations or individuals in accordance with the law.

5. Medical devices that are measuring instruments or radiation equipment must be managed in accordance with the law on measurement, the law on atomic energy, and the provisions of this Decree.

Chemicals and preparations with only one purpose of disinfecting medical devices shall be managed in accordance with the provisions of this Decree. Chemicals and preparations with the purpose of disinfecting medical devices but also having other uses shall be managed in accordance with the law on chemicals, insecticides, and bactericides used in household and medical fields.

 

Chapter II

CLASSIFICATION OF MEDICAL DEVICES

 

Article 4. LType of medical devices

Medical devices consist of two groups divided into four types based on the level of inherent risk related to the technical design and production of these medical devices:

1. Group 1 includes medical devices of type A, which are low-risk medical devices.

2. Group 2 includes medical devices of types B, C, and D, where:

a) Medical devices of type B are low-medium risk medical devices;

b) Medical devices of type C are medium-high risk medical devices;

c) Medical devices of type D are high-risk medical devices.

Article 5Principles of medical device classification

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

2. In cases where medical devices can be classified into two or more risk levels, the highest risk level of the medical device shall be applied.

3. In cases where medical devices are designed to be used in conjunction with another medical device, each medical device must be separately classified according to its risk level.

4. In cases where medical devices are used in conjunction with another medical device or have two or more purposes, classification must be based on the most important use of the medical device.

5. The Minister of Health shall provide detailed regulations on the classification of medical devices to ensure compatibility with international agreements on medical device classification of the Association of Southeast Asian Nations of which Vietnam is a member.

Article 6. Implementation of medical equipment classification

1. The classification of medical equipment must be carried out by an organization meeting the conditions stipulated in Article 7 of this Decree.

2. Organizations implementing the classification of medical equipment shall bear legal responsibility for the results of the classification of medical equipment they have classified.

3. In cases where there are differences in the results of the classification of medical equipment, the Ministry of Health shall decide on the classification of medical equipment.

Article 7. Conditions for organizations implementing the classification of medical equipment

1. Conditions for organizations implementing the classification of medical equipment:

a) Legally established in accordance with the provisions of the law;

b) Having personnel who meet the conditions stipulated in Clause 2 of this Article to carry out the classification of medical equipment.

2. Conditions for personnel carrying out the classification of medical equipment:

a) Having a degree in technical engineering or medical/pharmaceutical fields at the bachelor level or higher;

b) Having at least 24 months of direct work experience in medical equipment technology at hospitals, healthcare facilities with beds, specialized training institutions for medical equipment, research institutions for medical equipment, medical equipment manufacturing facilities, organizations implementing the classification of medical equipment, and medical equipment management agencies (hereinafter referred to as medical equipment facilities);

c) Having been tested and recognized as having the capability to classify medical equipment according to the training program issued by the Ministry of Health.

3. A facility may only implement the classification of medical equipment after being issued a receipt for acceptance of the declaration of qualification for medical equipment classification by the Ministry of Health in accordance with point b, Clause 1 of Article 9 of this Decree.

Article 8. Documents for declaring qualification for medical equipment classification

1. Documents for declaring qualification for medical equipment classification include:

a) A declaration of qualification for medical equipment classification in form number 01 as prescribed in Appendix I attached to this Decree;

b) A list of personnel in the format prescribed in Appendix II attached to this Decree, accompanied by a confirmation of work duration in the format prescribed in Appendix III attached to this Decree, and certificates of education of each person carrying out the classification of medical equipment.

2. Requirements for certain documents in the declaration:

a) Original or certified copy for the confirmation of work duration;

b) Certified copy for the certificates of education of each person carrying out the classification of medical equipment.

Article 9. Procedures for declaring qualification for medical equipment classification

1. Procedures for declaring qualification for medical equipment classification:

a) Before carrying out the classification of medical equipment, the organization implementing the classification of medical equipment shall submit the declaration documents for qualification for medical equipment classification as stipulated in Clause 1 of Article 8 of this Decree to the Ministry of Health;

b) Upon receiving complete and valid documents, the Ministry of Health shall issue a receipt for acceptance of the declaration of qualification for medical equipment classification in form number 01 as prescribed in Appendix IV attached to this Decree to the organization implementing the classification;

c) Within three working days from the date recorded on the receipt for acceptance of the declaration, the Ministry of Health shall be responsible for publishing on its electronic portal the following information: the name, address, and phone number of the organization implementing the classification of medical equipment and the declaration documents for qualification for medical equipment classification.

2. During operation, the organization implementing the classification of medical equipment must re-declare qualification for medical equipment classification if there are any changes related to the previous declaration documents.

Article 10. Recognition of Medical Device Classification Results

1. Medical devices shall not be required to undergo reclassification in Vietnam if they have been classified by the competent authority of a country that Vietnam recognizes based on international treaties or international agreements to which the Socialist Republic of Vietnam is a party, or a country applying a medical device classification system similar to that of Vietnam.

2. The Minister of Health shall publish a list of countries whose medical device classification results are recognized by Vietnam.

 

Chapter III

PRODUCTION OF MEDICAL DEVICES

 

Article 11. Investment Incentives for Medical Device Production Activities

1. Exemption or reduction of land rental fees:

a) An investor with a project to produce Class B medical devices who leases land from the State shall be entitled to apply the lowest price set by the People's Committee of the province or centrally governed city (hereinafter referred to as "province") and shall be exempted from land rental fees in accordance with the provisions of the law;

b) An investor with a project to produce Class C or D medical devices shall be exempted from land rental fees from the date the project is completed and put into operation;

c) An investor with a project to produce medical devices shall be exempted from land rental fees for the area used to build housing for workers, green space, and public welfare facilities.

2. In addition to the investment incentives stipulated in Clause 1 of this Article, medical device production projects shall also enjoy other investment incentives in accordance with the laws on investment and science and technology.

Article 12. Personnel Conditions for Medical Device Manufacturing Facilities

1. Qualifications of the person in charge of technical matters:

a) Possessing a degree of at least a college-level diploma in medical equipment technology or a bachelor’s degree or higher in engineering or medicine/pharmacy;

b) Having at least 24 months of direct work experience in medical equipment technology at medical equipment facilities;

c) Working full-time at the manufacturing facility. The assignment and appointment of the person in charge of technical matters at the manufacturing facility must be documented in writing.

2. Having a team of staff capable of meeting the production requirements for the type of medical devices produced by the facility.

Article 13. Conditions Regarding Physical Infrastructure, Equipment, and Quality Management of Medical Device Manufacturing Facilities

1. Having a location, area, and factory suitable for the type of medical devices produced by the facility.

2. Having equipment and production processes, quality inspection procedures suitable for the type of medical devices produced by the facility. In cases where there is no quality inspection equipment, a contract must be made with a facility having the capability to inspect quality to conduct quality inspections of the medical devices produced by the facility.

3. Having storage facilities meeting the following minimum conditions:

a) Having an area appropriate to the types and quantities of medical devices stored;

b) Ensuring ventilation, dryness, cleanliness, and distance from sources of pollution;

c) Meeting other storage requirements of medical devices according to usage instructions.

4. Having transportation means for moving medical devices from the manufacturing facility to the delivery location suitable for the type of medical devices produced by the facility.

5. Implementing a quality management system as prescribed in Clause 1 of Article 68 of this Decree.

6. In cases where the facility does not have storage facilities and transportation means for medical devices, it must enter into contracts with facilities meeting the requirements for storage and transportation of medical devices as stipulated in Clauses 3 and 4 of this Article.

Article 14. Documents for announcement meeting conditions for medical device production

The documents for announcing meeting conditions for medical device production include:

1. Announcement document meeting production conditions according to Model No. 02 prescribed in Appendix I issued together with this Decree.

2. Personnel declaration form according to the model prescribed in Appendix II issued together with this Decree.

3. Assignment and appointment document of the person in charge of the production facility, accompanied by a confirmation of working period according to the model prescribed in Appendix III issued together with this Decree and certificates of training of the person in charge.

4. Certificate of quality management standard compliance.

In case there is no certificate of quality management standard compliance, then documents proving that the facility meets the conditions stipulated in Clauses 1, 2, 3, and 4 of Article 13 of this Decree must be provided.

If the production facility does not conduct product quality testing itself or does not have storage facilities or transportation means and instead contracts these services with another entity, it must provide documents proving that such entity has the necessary conditions for quality testing, storage, and transportation of the medical devices produced.

Article 15Requirements for documents announcing meeting conditions for medical device production

1. The documents announcing meeting conditions for medical device production shall consist of 01 set, including:

a) The documents in the set shall be clearly printed, arranged in the order prescribed in Article 14 of this Decree; parts shall be separated, with a cover page and a list of documents;

b) Documents not in English must be translated into Vietnamese.

2. Requirements for some documents in the set of documents announcing meeting conditions for production:

a) Original or certified copy of the assignment and appointment document, certificates of training of the person in charge of the production facility;

b) Original or certified copy of documents proving that the facility meets the conditions stipulated in Clauses 1, 2, 3, and 4 of Article 13 of this Decree;

c) Original or certified copy or certified copy of the declaration facility for the Certificate of Quality Management Standard Compliance.

Article 16Procedure for announcing meeting conditions for medical device production

1. A production facility may only produce medical devices after receiving from the Department of Health a receipt for the documents announcing meeting production conditions as prescribed in Point b Clause 2 of this Article.

2. The procedure for announcing meeting production conditions:

a) Before commencing medical device production, the head of the medical device production facility is responsible for submitting the documents announcing meeting production conditions as prescribed in Article 14 of this Decree to the Department of Health where the production facility is located;

b) Upon receiving complete and valid documents, the Department of Health issues to the facility a Receipt for Documents Announcing Meeting Production Conditions according to Model No. 02 prescribed in Appendix IV issued together with this Decree;

c) Within three working days from the date recorded on the Receipt for Documents Announcing Meeting Production Conditions, the Department of Health is responsible for publicly disclosing on its electronic portal the following information: name of the production facility; name of the person in charge of the production facility; medical devices produced by the facility; address, contact phone number, and documents announcing meeting production conditions, except for production procedures and quality control procedures.

3. During operation, the production facility must re-perform the procedure for announcing meeting production conditions if there is any change related to the previous announcement documents.

4. In case the production facility changes its production location from one province to another, it must notify the Department of Health where the facility previously announced meeting production conditions within ten working days from the date of changing the production location.

Within three working days from the date of receiving notification about the transfer of the production location to another province, the Department of Health which received the documents announcing meeting production conditions is responsible for ceasing the publication of information related to that facility.

 

Chapter IV

CIRCULATION OF MEDICAL DEVICES

 

Section 1

CONDITIONS FOR CIRCULATION, CIRCULATION NUMBERS AND

CONDITIONS OF THE ORGANIZATION LISTED TO ANNOUNCE APPLICABLE STANDARDS OR REGISTER FOR CIRCULATION

 

Article 17. Conditions for circulation of medical devices

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

a) Having valid circulation numbers or having been granted import permits in accordance with this Decree;

b) Having labels or accompanying labels containing all information as prescribed in Article 54 of this Decree;

c) Having technical documentation to serve repair and maintenance of medical devices, except for single-use medical devices as defined by the owner of the medical device;

d) Having usage instructions for medical devices in Vietnamese;

đ) Having information about warranty facilities, warranty conditions and duration, except for single-use medical devices as defined by the owner of the medical device.

2. In cases where the information specified in points c, d, and đ of Clause 1 of this Article is not attached to the medical device, it must be provided in electronic form and clearly indicate how to access the information on the label of the medical device.

Article 18. Conditions for announcing applicable standards or issuing certificates of registration for circulation of medical devices

1. Conditions for announcing applicable standards or issuing certificates of registration for circulation of medical devices:

a) Produced at production facilities that have announced sufficient production conditions for domestically produced medical devices;

b) Produced at production facilities that have obtained Certificates of Quality Management Standards Compliance and are circulated in any country worldwide for imported medical devices;

c) Complying with national technical regulations or standards declared by the manufacturer to apply.

2. Repeating the procedure for announcing applicable standards or registering for circulation will not be allowed for medical devices under any of the following circumstances:

a) Medical devices falling under the provisions of Clause 1 of Article 34 of this Decree;

b) Recalled medical devices falling under the provisions of Clauses 1 and 3 of Article 35 of this Decree.

3. Applications for announcing applicable standards or registering for circulation will not be accepted within a period of 12 months from the date of the decision to revoke the circulation registration number for medical devices falling under the provisions of Clauses 2 and 8 of Article 35 of this Decree.

Article 19. Medical devices exempted from announcing applicable standards and registering for circulation

1. Medical devices solely for research, testing, usage guidance, and repair purposes.

2. Imported medical devices into Vietnam for aid purposes or for use in trade fairs, exhibitions, displays, product presentations, or as gifts, donations, or presents.

3. Medical devices produced in Vietnam exclusively for export or participation in overseas exhibitions, trade fairs, or displays.

Article 20. Circulation numbers of medical devices

1. The circulation number of medical devices is:

a) The receipt number of the application file for announcing applicable standards for type A medical devices according to Form No. 03 prescribed in Appendix IV issued together with this Decree;

b) The certificate number of registration for circulation for type B, C, and D medical devices according to Form No. 09 prescribed in Appendix IV issued together with this Decree.

2. The circulation number may be assigned to one or a group of types of medical devices.

3. The holder of the circulation number is the organization announcing applicable standards for type A medical devices or the organization receiving the circulation number for type B, C, and D medical devices.

4. Validity of the circulation number:

a) The circulation number for type A medical devices has indefinite validity;

b) The circulation number for type B, C, and D medical devices has a validity of five years from the date of issuance. If the circulation number for medical devices is extended, the previously issued number remains unchanged.

Article 21. Conditions for organizations to be named in announcing applicable standards or registering medical devices for circulation

1. Organizations that can be named in announcing applicable standards or registering medical devices for circulation include:

a) Vietnamese enterprises, cooperatives, or individual businesses that are owners of medical devices;

b) Vietnamese enterprises, cooperatives, or individual businesses with functions of trading in medical devices authorized by the owner of the medical devices to register;

c) Representative offices of foreign traders established in Vietnam where such traders are the owners of medical devices or have been authorized by the owners of the medical devices.

2. Organizations named in announcing applicable standards or registering medical devices for circulation must have warranty facilities in Vietnam or must have contracts with organizations capable of providing warranty services for the medical devices they register, except in cases where the medical devices are single-use as defined by the owner of the medical devices.

In cases where the organization named in announcing applicable standards or registering medical devices for circulation falls under the provisions of point c, Clause 1, Article 21 of this Decree, the owner of the medical devices must have warranty facilities in Vietnam or must have contracts with warranty facilities capable of providing warranty services for the medical devices they announce or register, except in cases where the medical devices are single-use as defined by the owner of the medical devices.

The warranty facility must be certified by the owner of the medical devices as having the capability to provide warranty services for the products for which the organization has requested registration numbers.

 

Section 2

ANNOUNCEMENT OF APPLICABLE STANDARDS FOR CLASS A MEDICAL DEVICES

 

- Prime Minister;22. Announcement Documents for Applicable Standards

The announcement documents for applicable standards for Class A medical devices include:

1. The announcement document for applicable standards of Class A medical devices according to Model No. 03 prescribed in Appendix I issued together with this Decree.

2. The classification document of medical devices according to the model prescribed in Appendix V issued together with this Decree.

3. The acceptance receipt for the production condition announcement application documents for domestically produced medical devices or the Certificate of Quality Management Compliance still valid at the time of submitting the announcement application documents for imported medical devices.

4. The authorization letter from the owner of the medical devices to the organization named in announcing applicable standards according to the model prescribed in Appendix VI issued together with this Decree, still valid at the time of submitting the application documents, except in cases stipulated in point a, Clause 1, Article 21 of this Decree.

5. The certificate confirming the warranty conditions issued by the owner of the medical devices according to the model prescribed in Appendix VII issued together with this Decree, except in cases where the medical devices are single-use as defined by the owner of the medical devices.

6. Technical description documents of medical devices according to Model No. 01 prescribed in Appendix VIII issued together with this Decree.

7. The standard announced by the owner of the medical devices for application or the Certificate of Conformity.

8. User guide documents of medical devices.

9. Sample labels to be used when circulating in Vietnam for medical devices.

Article 23. Requirements for the Standard Application Announcement File

1. The Standard Application Announcement file shall be made into one set.

2. Requirements for some documents in the Standard Application Announcement file:

a) For the Receipt Form for Submission of the Standard Application Announcement File: Submit a certified copy by the organization named in the announcement of the standard application.

b) For the Certificate of Compliance with Quality Management Standards: Submit the original or a notarized copy or a certified copy by the organization named in the announcement of the standard application.

In case of submitting a certified copy by the organization named in the announcement of the standard application, when submitting the file, the original must be presented for verification or source data must be provided for the receiving authority to check the validity of these documents.

If the Certificate of Compliance with Quality Management Standards is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with the provisions of the law.

c) For the power of attorney from the owner of medical devices and the confirmation of the facility meeting the warranty conditions:

- For domestically produced medical devices: Submit the original or a notarized copy;

- For imported medical devices: Submit a copy legalized by consular authentication or a notarized copy of the copy that has been legalized by consular authentication.

d) For the Certificate of Conformity or the Standard Document announced by the owner of the medical device: Submit a certified copy by the organization named in the announcement of the standard application.

If the Standard Document is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with the provisions of the law;

đ) For the user manual of the medical device: Submit a Vietnamese version certified by the organization named in the announcement of the standard application;

e) For the label sample: Submit a label sample certified by the organization named in the announcement of the standard application. The label sample must meet the requirements stipulated in Article 54 of this Decree.

Article 24. Procedure for Announcing the Application of Standards

1. Medical devices of type A may only be circulated on the market after having received a receipt form for submission of the standard application announcement issued by the Department of Health in accordance with point b, Clause 2 of this Article.

2. Procedure for announcing the application of standards:

a) Before circulating medical devices of type A on the market, the entity responsible for bringing medical devices to the market shall submit the standard application announcement file in accordance with Article 22 of this Decree to the Department of Health where the entity's headquarters is located;

b) Upon receiving a complete and valid file, the Department of Health shall issue the Receipt Form for Submission of the Standard Application Announcement to the entity performing the announcement according to Model No. 03 prescribed in Appendix IV attached to this Decree;

c) Within three working days from the date recorded on the Receipt Form for Submission of the File, the Department of Health shall be responsible for publicly disclosing on its electronic portal the following information: name, classification, production facility, country of production of the medical device; circulation number of the medical device; name and address of the owner of the medical device; name and address of the owner of the circulation number; name and address of the warranty facility of the medical device and the standard application announcement file of the medical device.

3. In cases where there is a change in the owner of the medical device; name, production facility, country of production of the medical device, the owner of the circulation number shall be responsible for re-performing the announcement of the application of standards in accordance with the provisions of this Decree.

 

Section 3

REGISTRATION FOR CIRCULATION OF MEDICAL DEVICES

OF TYPES B, C, AND D

 

Article 25. Forms of Registration for Circulation

1. Issuance of new circulation numbers applies to medical devices in the following cases:

a) Medical devices requesting issuance of a circulation number for the first time;

b) Medical devices that have already been issued a circulation number but have undergone one of the following changes: type of medical device; raw materials affecting the function of in vitro diagnostic medical devices and single-use medical devices;

c) Medical devices that have already been issued a circulation number but have not renewed their registration for circulation number extension within the period specified in Clause 3, Article 27 of this Decree.

2. Reissuance of circulation numbers applies to cases where the Certificate of Circulation is lost or damaged.

3. Extension of circulation numbers applies to cases where the circulation number is about to expire as specified in Clause 3, Article 27 of this Decree.

- Prime Minister;26. File for Requesting New Circulation Numbers

1. File for requesting new circulation numbers for medical devices without corresponding national technical regulations:

a) Request for issuance of new circulation numbers according to Model No. 04 prescribed in Appendix I attached to this Decree;

b) Classification document of medical devices according to the model prescribed in Appendix V attached to this Decree;

c) Certificate of compliance with quality management standards still valid at the time of filing, except in cases where the medical device has already been issued a free circulation certificate from one of the following countries or organizations: member states of the EU, Japan, Canada, TGA of Australia, FDA of the United States;

d) Power of attorney from the owner of the medical device to the entity performing the registration for circulation according to the model prescribed in Appendix VI attached to this Decree, still valid at the time of filing, except in cases stipulated in point a, Clause 1, Article 21 of this Decree;

đ) Confirmation of meeting warranty conditions issued by the owner of the medical device according to the model prescribed in Appendix VII attached to this Decree, except in cases of single-use medical devices as stipulated by the owner of the medical device;

e) Free circulation certificate still valid at the time of filing for imported medical devices;

g) Technical summary description document of the medical device according to Model No. 01 prescribed in Appendix VIII attached to this Decree;

h) Technical feature description document of the medical device; For reagents, calibration materials, in vitro control materials: submit technical documents according to Model No. 02 prescribed in Appendix VIII attached to this Decree;

i) User manual of the medical device;

k) For medical devices classified as type C, D that intrude into the human body: A summary of clinical trial data according to the model prescribed in Appendix IX attached to this Decree, along with the results of clinical research trials, except for the following cases:

- Medical devices produced or processed in Vietnam solely for export purposes where the importing country does not require clinical trials;

- Medical devices that have been circulated and issued a free circulation certificate by one of the following countries or organizations: EU member states, Japan, Canada, TGA of Australia, FDA of the United States;

- Other cases as specified by the Minister of Health.

l) For in vitro diagnostic medical devices classified as type C, D, there must be an additional test certification as stipulated by the Minister of Health, except in the case where the medical device has already been issued a free circulation certificate by one of the following countries or organizations: EU member states, Japan, Canada, TGA of Australia, FDA of the United States;

m) The label sample to be used when circulating in Vietnam.

2. Application dossier for issuing a new registration number for medical devices corresponding to national technical standards:

a) A request for issuing a new registration number according to model number 04 prescribed in Appendix I attached to this Decree;

b) Certificate of conformity;

c) Documents as provided for in points b, c, d, đ, e, g, i, and m of Clause 1 of Article 26 of this Decree;

3. Application dossier for issuing a new circulation number for measuring instruments classified as medical devices which require approval of samples according to measurement laws:

a) A request for issuing a new registration number according to model number 04 prescribed in Appendix I attached to this Decree;

b) Approval decision on samples;

c) Documents as provided for in points b, c, d, đ, e, g, i, and m of Clause 1 of Article 26 of this Decree;

4. Application dossier for issuing a new circulation number for measuring instruments classified as medical devices but not requiring approval of samples according to measurement laws shall be carried out in accordance with Clause 1 of Article 26 of this Decree.

Article 27. Application dossier for reissuing and extending circulation numbers

1. Application dossier for reissuing circulation numbers in the event of loss or damage: A request for reissuing circulation numbers according to model number 05 prescribed in Appendix I attached to this Decree.

2. Application dossier for extending circulation numbers includes:

a) A request for extending circulation numbers according to model number 06 prescribed in Appendix I attached to this Decree;

b) A copy of the circulation registration certificate that has been issued;

c) Certificate of compliance with quality management standards still valid at the time of filing, except in cases where the medical device has already been issued a free circulation certificate from one of the following countries or organizations: member states of the EU, Japan, Canada, TGA of Australia, FDA of the United States;

d) Power of attorney from the owner of the medical device to the entity responsible for registering circulation according to the model prescribed in Appendix VI attached to this Decree, except in the case provided for in point a of Clause 1 of Article 21 of this Decree;

đ) Free circulation certificate for imported medical devices still valid at the time of submitting the application dossier;

e) Report on business operation results during the period covered by the circulation number according to the model prescribed in Appendix X attached to this Decree.

3. The deadline for submitting an application dossier for extending circulation numbers is at least 60 days before the circulation number expires.

Article 28. Requirements for application dossiers for issuing new and extending circulation numbers

1. Application dossier for issuing new or extending circulation numbers for medical devices shall consist of one set, with clear printing of all documents in the dossier arranged in the sequence prescribed in Article 26 of this Decree for new issuance application dossiers or in Clause 2 of Article 27 of this Decree for extension application dossiers; there should be separation between each document, cover page, and list of documents.

2. Requirements for some documents in the registration dossier:

a) For Quality Management System Certification: Submit the original or certified copy or confirmed copy by the organization requesting the circulation number.

In the case of submitting a confirmed copy by the organization requesting the circulation number, the original must be presented for verification or the source data must be provided for the authority receiving the dossier to verify the validity of these documents.

If the Certificate of Compliance with Quality Management Standards is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with the provisions of the law.

b) For power of attorney from the owner of the medical device and confirmation of the facility's warranty conditions:

- For domestically produced medical devices: Submit the original or a notarized copy;

- For imported medical devices: Submit a copy legalized by consular authentication or a notarized copy of the copy that has been legalized by consular authentication.

c) For free circulation certificates: Submit a legalized copy or certified copy of the legalized original.

If the free circulation certificate is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with the law.

If the free circulation certificate does not clearly state its expiration date, the expiration date will be calculated as 36 months from the date of issue.

d) For technical documentation of medical devices: Submit a copy confirmed by the organization requesting the circulation number.

If the technical documentation is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with the law;

đ) For user manuals of medical devices: Submit a Vietnamese version confirmed by the organization requesting the circulation number.

e) For test certification: Submit the original or certified copy or confirmed copy by the organization requesting the circulation number.

If a confirmed copy by the organization requesting the circulation number is submitted, the original must be presented for verification.

g) For label samples: Submit a label sample confirmed by the entity named in the circulation registration. The label must meet the requirements stipulated in Article 54 of this Decree.

Article 29. Acceptance and review of medical device circulation registration dossiers

1. The organization requesting the circulation number submits the dossier to the Ministry of Health.

2. After receiving the circulation registration dossier, the Ministry of Health sends the organization requesting the circulation number a receipt for the medical device circulation registration dossier according to model number 04 prescribed in Appendix IV attached to this Decree. The dossier will not be accepted if it does not meet the requirements stipulated in Article 28 of this Decree.

3. In the absence of requests for modification or supplementation of the circulation registration dossier, the Minister of Health is responsible for:

a) For medical devices that do not have corresponding national technical regulations: organize the assessment to issue a new circulation number within sixty days or extend the circulation number within thirty days from the date recorded on the Application Form Receipt. In cases where a new issuance or extension of the circulation number is not granted, there must be a written response specifying the reasons.

b) For medical devices that have corresponding national technical regulations: organize the assessment to issue a new circulation number within fifteen days or extend the circulation number within ten days from the date recorded on the Application Form Receipt. In cases where a new issuance or extension of the circulation number is not granted, there must be a written response specifying the reasons.

Reissue the circulation number within five working days from the date recorded on the Application Form Receipt. In cases where reissuance of the circulation number is not granted, there must be a written response specifying the reasons.

4. Where the application for circulation registration is incomplete, the Ministry of Health shall notify the organization requesting a new issuance, reissuance, or extension of the circulation number to supplement and amend the application for circulation registration, specifying in detail which documents need to be supplemented and which contents need to be amended within the following timeframes:

a) Fifteen working days from the date recorded on the Application Form Receipt for applications requesting a new issuance or extension of the circulation number;

b) Five working days from the date recorded on the Application Form Receipt for applications requesting reissuance of the circulation number.

5. Upon receiving a request for supplementation and amendment of the application for circulation registration, the organization requesting the circulation number must supplement and amend according to the contents specified in the notification and submit it to the Ministry of Health. The receipt date for the supplemented and amended application is recorded on the Application Form Receipt.

If the organization requesting the circulation number has supplemented and amended the application but does not comply with the requirements, the Ministry of Health will notify the organization requesting the circulation number to continue completing the application in accordance with Clause 4 of this Article.

After sixty days from the date the Ministry of Health issues a request for supplementation and amendment of the application, if the organization does not supplement and amend the application, the procedure for requesting the issuance of the circulation number must be restarted from the beginning.

6. Where the assessment council requests supplementation and amendment of the application, within ten working days from the date of the meeting minutes, the Ministry of Health shall notify the organization requesting the circulation number to supplement the application. The notification must specify in detail which documents need to be supplemented and which contents need to be amended.

Upon receiving a request for supplementation and amendment of the application for circulation registration, the organization requesting the circulation number must supplement and amend according to the contents specified in the notification and submit it to the Ministry of Health. The receipt date for the supplemented and amended application is recorded on the Application Form Receipt.

If the organization requesting the circulation number has supplemented and amended the application but does not comply with the requirements, the Ministry of Health will notify the organization requesting the circulation number to continue completing the application in accordance with Clauses 4 and 5 of this Article.

Within three working days from the date of issuance of the circulation number, the Ministry of Health shall be responsible for publicly disclosing on its electronic portal the following information:

a) Name, classification, manufacturing facility, country of manufacture of the medical device;

b) Circulation number of the medical device;

c) Name and address of the owner of the medical device;

d) Name and address of the owner of the circulation number;

đ) Name and address of the warranty facility of the medical device;

e) Application for circulation registration of the medical device, except for the information provided for in point h of Clause 1 of Article 26 of this Decree.

8. During the circulation period of the medical device, the owner of the circulation number shall be responsible for notifying the Ministry of Health in writing within ten working days from the date of any of the following changes:

a) Change of address of the owner of the medical device or the owner of the circulation number of the medical device;

b) Change of name of the owner of the circulation number. The owner of the circulation number shall be responsible for submitting along with the change notification the relevant documents proving ownership of the medical device by the new owner and the label model in accordance with Article 54 of this Decree;

c) Change in any of the information about the name or address of the manufacturing facility of the medical device. The owner of the circulation number shall be responsible for submitting along with the change notification the following documents: Free Circulation Certificate and Quality Management Standard Compliance Certificate still valid at the time of submission, except in cases where the medical device has already been issued a Free Circulation Certificate by one of the following countries or organizations: member states of the EU, Japan, Canada, TGA of Australia, FDA of the United States;

d) Change in packaging specifications for in vitro diagnostic medical devices. The owner of the circulation number shall be responsible for submitting along with the change notification the relevant documents as stipulated in points h and m of Clause 1 of Article 26 of this Decree;

đ) Change in warranty facility. The owner of the circulation number shall be responsible for submitting along with the change notification the relevant documents as stipulated in point đ of Clause 1 of Article 26 of this Decree.

9. Within three working days from the date of receipt of the notification from the owner of the circulation number, the Ministry of Health shall be responsible for updating the changed information in the medical device management file and on the electronic portal.

10. The Minister of Health shall prescribe the procedures for assessing applications for issuance of circulation numbers as stipulated in Clause 3 of this Article.

 

Section 4

TRACEBACK, HANDLING, REMEDY,

SUSPENSION OF CIRCULATION, RECALL FOR DEFECTIVE MEDICAL DEVICES AND HANDLING IN CERTAIN SPECIAL CASES

FOR MEDICAL DEVICES

 

Article 30. Tracing the Origin of Defective Medical Devices

1. For defective medical devices, the owner of the registration number must carry out tracing the origin according to the following contents:

a) Identify the name, type, and quantity of the medical devices in the batch of defective products;

b) Announce on the electronic information website of the owner (if available) and the Ministry of Health's electronic information portal, while requesting in writing from production facilities, sellers, and users of medical devices to provide information about the name, type, quantity of the medical devices in the batch of defective products, actual inventory, and those circulating in the market;

c) Develop a plan to address and rectify or recall defective medical devices;

d) Summarize and report to the competent state agency about the recall plan and measures taken.

2. The competent state agency has the responsibility to inspect and supervise the implementation of tracing the origin of defective medical devices within its management authority.

Article 31. Handling, Rectifying, and Recalling Defective Medical Devices

1. Forms of handling defective medical devices include:

a) Guidance on corrective measures for defects;

b) Rectification of defects in medical devices;

c) Replacement of defective medical devices with corresponding ones;

d) Recall for re-exportation or destruction.

2. Defective medical devices subject to recall shall be carried out in the following forms:

a) Voluntary recall implemented by the owner of the registration number;

b) Mandatory recall for cases stipulated in Article 35 of this Decree.

3. The owner of the registration number of defective medical devices is responsible for recalling and handling defective medical devices within the time limit decided by the competent state agency and bears all costs associated with the recall and handling of defective medical devices.

In case the owner of the registration number fails to implement the recall within the time limit decided by the competent state agency, compulsory recall will be enforced in accordance with the law on administrative violation handling.

Article 32. Procedures for Suspending Circulation of Medical Devices with Warnings Issued by the Owner Regarding Defective Medical Devices Affecting User Health

1. In the event that it is determined that defective medical devices affect user health, the owner of the registration number is responsible for:

a) Temporarily suspending circulation of the medical devices;

b) Issuing a written notice to the Ministry of Health and organizations and individuals involved in distribution and use of the medical devices. The notice must clearly specify the production batch, the defect causing adverse effects on user health, and whether or not the defect can be rectified.

2. In the case where the defect causing adverse effects on user health can be rectified:

a) Within three working days from receiving the notice from the owner of the medical device, the Ministry of Health is responsible for issuing a decision to suspend circulation of the medical device;

b) After the decision to suspend circulation of the medical device is issued, the owner of the registration number in Vietnam is responsible for rectifying the defect causing adverse effects on user health;

c) Upon completion of rectifying the defect causing adverse effects on user health, the owner of the registration number is responsible for submitting a written report to the Ministry of Health, which must include a commitment to ensure the quality of the medical device after rectification or the testing results from a laboratory meeting national standards for laboratory capability and calibration TCVN ISO/IEC 17025 or international standard ISO/IEC 17025 or equivalent;

d) Within twenty days from receiving the report on rectifying the defect causing adverse effects on user health submitted by the owner of the registration number, the Ministry of Health is responsible for issuing a decision to terminate the suspension of circulation of the medical device. If the Ministry of Health disagrees with terminating the suspension, it must issue a written response specifying the reasons for refusal.

3. In the case where the defect causing adverse effects on user health cannot be rectified, the Ministry of Health is responsible for issuing a decision to recall the entire batch of suspended medical devices.

4. Contents of the decision to suspend circulation:

a) Name of the medical device suspended;

b) Batch number of the suspended medical device;

c) Registration number of the suspended medical device;

Article 33. Suspension Procedure for Medical Devices with Warnings from Competent Authorities Regarding Defects Affecting User Health

1. Within five working days from the date of receipt of the notification regarding factors causing adverse health effects on users of medical devices sent by healthcare facilities or countries where such medical devices are circulating, or by the World Health Organization, the Ministry of Health shall be responsible for sending a document requesting the owner of the registration number to report and explain.

2. Within five working days from the date of receipt of the document from the Ministry of Health, the owner of the registration number shall be responsible for sending a report to the Ministry of Health.

3. Within five working days from the date of receipt of the report from the owner of the registration number for medical devices in Vietnam, the Ministry of Health shall be responsible for establishing a scientific council to assess factors causing adverse health effects on users of medical devices.

4. In case it is determined that the medical device does not have factors affecting user health adversely, within three working days from the date of receipt of the meeting minutes of the Council, the Ministry of Health shall be responsible for issuing a document to notify the owner of the registration number in Vietnam.

5. In case it is determined that the medical device has defects causing adverse health effects on users, the Ministry of Health shall be responsible for implementing the suspension procedure as stipulated in Clauses 2, 3, and 4 of Article 32 of this Decree.

Article 34. Handling of Medical Devices When the Owner of the Medical Device or the Owner of the Registration Number Ceases Production or Goes Bankrupt, Dissolves

1. Medical devices that have been granted a registration number but whose owners declare they will cease production or go bankrupt or dissolve may continue to circulate for a maximum period of twenty-four months from the date the owner declares they will cease production or go bankrupt or dissolve if the owner of the registration number in Vietnam commits to assuming responsibility for warranty, maintenance, and providing spare parts or supplies for the use of the medical device for eight years, except in cases where the owner of the registration number is the permanent representative office in Vietnam of a foreign trader who is the owner of the medical device.

2. Medical devices that have been granted a registration number but whose owners of the registration number go bankrupt or dissolve may continue to circulate in the market for a maximum period of twenty-four months from the date the owner of the registration number declares bankruptcy or dissolution if the distributor commits to assuming responsibility for warranty, maintenance, and providing spare parts or supplies for the use of the medical device for a maximum period of eight years.

3. The owner of the registration number or the distributor shall be responsible for submitting the commitment file to the Ministry of Health within the latest sixty days from the date the owner of the medical device or the owner of the registration number declares they will cease production or go bankrupt or dissolve.

4. The commitment file includes the following documents:

a) A commitment document to assume responsibility for warranty, maintenance, and provision of supplies for the use of medical devices according to the model prescribed in Appendix XI attached to this Decree;

b) A list of medical devices with registration numbers that the entity is holding but whose owners of the medical devices or owners of the registration numbers declare they will cease production or go bankrupt or dissolve.

5. Within fifteen working days from the date of receipt of the commitment file as stipulated in Clause 4 of this Article, the Ministry of Health shall be responsible for replying in writing whether to allow or not to allow continued circulation of the medical devices. If not allowed, the reasons must be clearly stated.

6. In case the medical devices specified in Clause 1 of this Article are not permitted to continue circulating by the Ministry of Health, the owner of the registration number or the distributor shall be responsible for conducting the recall of the medical devices circulating in the market, except for those already sold to users.

Section 5

RECALL OF REGISTRATION NUMBERS FOR MEDICAL DEVICES

 

Article 35. Cases for Revoking the Circulation Number

1. An organization registers false registration documents.

2. Medical devices have three batches forcibly suspended from circulation during the validity period of the registration number for medical devices classified as type B, C, or D, or within five years for medical devices classified as type A, except where the owner of the circulation number voluntarily revokes it in accordance with Article 32 of this Decree.

3. The registration organization repairs, erases, or alters the content of the circulation number.

4. The owner of the circulation number ceases operations or no longer has authorization from the owner of the medical device without a replacement organization taking over, except as provided for in Article 34 of this Decree., 5. Medical devices circulating on the market do not meet the registered quality standards.

6. The circulation number was issued beyond authority, or with incorrect documentation or procedures as stipulated in this Decree.

7. Medical devices whose owners of the registration number or distributors do not have commitments as prescribed in Clauses 1 and 2 of Article 34 of this Decree.

8. Medical devices that exceed their circulation period as specified in Clauses 1 and 2 of Article 34 of this Decree.

9. Medical devices produced at facilities that do not meet the conditions stipulated in this Decree.

Article 36. Procedures for Revoking the Circulation Number

1. During inspections and audits, if any of the cases as prescribed in Clauses 1, 2, 3, 4, 5, 6, 8, and 9 of Article 35 of this Decree are discovered, the inspection or audit agency must prepare a record and send it to the Ministry of Health or the Provincial Health Department that issued the circulation number (hereinafter referred to as the issuing authority).

2. Within five working days from the date of receipt of the record as prescribed in Clause 1 of this Article, the issuing authority shall examine and decide on the revocation of the circulation number within its management jurisdiction.

3. After issuing the decision to revoke the circulation number, the issuing authority shall be responsible for:

a) Publishing the full text of the decision to revoke the circulation number on the electronic portal of the issuing authority, and simultaneously sending the decision to revoke the circulation number to the owner of the circulation number, the Ministry of Health, and other provincial health departments nationwide;

b) Removing all information related to the medical devices published on the electronic portal of the issuing authority.

3. Upon receiving the decision to revoke the circulation number from the issuing authority, provincial health departments shall be responsible for publishing the full text of the decision to revoke the circulation number on their electronic portals, and directing relevant agencies to supervise the recall of the medical devices.

MANAGEMENT OF PURCHASE AND SALE OF MEDICAL DEVICES

 

Chapter V

CONDITIONS FOR THE PURCHASE AND SALE OF MEDICAL DEVICES

 

Section 1

Article 37. Conditions for Organizations Engaged in the Purchase and Sale of Medical Devices Classified as Type B, C, or D

 

1. To have a technical staff team with appropriate qualifications to install and guide the use of medical devices sold by the organization, including at least one technician with a college degree in engineering, medicine, pharmacy, or medical equipment technology, or a college degree in another field suitable for the type of medical device sold by the organization.

2. To have a warehouse meeting the requirements set out in Clause 3 of Article 13 of this Decree, and transportation means from the purchasing and selling facility to the delivery location that comply with the manufacturer's requirements, except where otherwise provided by law. In cases where there is no warehouse or storage facility for medical devices, there must be a contract with a capable entity to store and transport the medical devices.

2. Must have storage facilities meeting the requirements stipulated in Clause 3, Article 13 of this Decree and transportation means from the purchasing and selling premises to the delivery location that comply with the manufacturer's requirements, except where otherwise provided by law. In cases where there is no storage facility or equipment preservation means for medical devices, there must be a contract with a competent entity to store and transport such medical devices.

Article 38. Documents and Procedures for Announcing Sufficient Conditions for Medical Equipment Trading

1. The documents for announcing sufficient conditions for medical equipment trading shall be compiled into one set including the following papers:

a) A declaration of sufficient conditions for medical equipment trading according to Model No. 07 prescribed in Appendix I issued together with this Decree;

b) A personnel declaration form according to the model prescribed in Appendix II issued together with this Decree;

c) Papers proving that the storage warehouse and transportation means for medical equipment meet the requirements stipulated in Clauses 3 and 4, Article 13 of this Decree. These papers must be confirmed by the entity declaring sufficient conditions for trading.

2. Procedures for announcing sufficient conditions for trading:

a) Before conducting trade in Class B, C, and D medical equipment, the head of the medical equipment trading entity shall be responsible for submitting the documents for announcing sufficient conditions for trading as prescribed in Clause 1 of this Article to the Department of Health where the trading entity is located;

b) Upon receiving the documents, the Department of Health shall issue the trading entity a Receipt for Documents for Announcing Sufficient Conditions for Trading according to Model No. 05 prescribed in Appendix IV issued together with this Decree;

c) Within three working days from the date of receipt of the documents for announcing sufficient conditions for trading, the Department of Health shall be responsible for publicly disclosing on its electronic portal the following information: the name and address of the medical equipment trading entity; the documents for announcing sufficient conditions for trading.

3. The entity may only conduct trade in Class B, C, and D medical equipment after completing the procedures for announcing sufficient conditions for trading as prescribed in Clause 2 of this Article, except in cases provided for in Article 39 of this Decree.

4. During operation, the trading entity must re-perform the procedures for announcing sufficient conditions for trading if there are changes in personnel, storage warehouses, and transportation means for medical equipment.

Article 39. Trading in Medical Equipment Without Meeting Conditions and Without Completing Procedures for Announcing Sufficient Conditions for Trading

1. Class B, C, and D medical equipment listed in the medical equipment catalog issued by the Minister of Health may be traded like ordinary goods.

2. Trading in medical equipment as prescribed in Clause 1 of this Article does not need to meet the conditions stipulated in Article 37 of this Decree and does not require completion of procedures for announcing sufficient conditions for trading as prescribed in Article 38 of this Decree but still must comply with the storage, retention, and transportation conditions prescribed by the owner of the medical equipment.

 

Section 2

EXPORT AND IMPORT OF MEDICAL EQUIPMENT

 

Article 40. Principles for Managing Export and Import of Medical Equipment

1. Organizations and individuals engaged in exporting and importing medical equipment must meet the conditions prescribed by laws on export and import and must be responsible for ensuring the quality of the medical equipment they export and import.

2. Medical equipment already registered for circulation in Vietnam can be exported and imported based on demand without quantity restrictions and without approval from the Ministry of Health.

3. Issuance of free circulation certificates applies only to exported medical equipment as prescribed by the Prime Minister.

4. Temporary import for re-export, temporary export for re-import, transshipment, or transit of medical equipment shall be carried out in accordance with the provisions of the law.

5. Importation of used medical equipment shall be carried out in accordance with the provisions of the law on commerce.

Article 41. Exporting and Importing Medical Equipment

1. Encourage domestic enterprises to produce for export.

2. Organizations and individuals implementing the import of medical equipment that have circulation numbers must meet the following conditions:

a) Being the owner of the circulation number or having a power of attorney from the owner of the circulation number. The owner of the circulation number when authorizing the importing entity to carry out the import of medical equipment must simultaneously send the authorization document to the Ministry of Health and customs authorities.

b) Having a warehouse meeting the requirements stipulated in Clause 3, Article 13 of this Decree and having transportation means suitable for the type of medical equipment that the importing entity possesses or has a contract with an entity capable of storing and transporting medical equipment.

3. The procedures and formalities for exporting and importing medical equipment shall be carried out in accordance with the provisions of the Law on Customs. The importing organization does not need to prove compliance with the conditions stipulated in Clause 2 of this Article when handling customs procedures.

Article 42. Import Permit

1. Cases where medical equipment must have an import permit:

a) Not having a circulation number for import for scientific research or testing or for guiding the use and repair of medical equipment;

b) Not having a circulation number for import for aid purposes;

c) Not having a circulation number for import for personal medical treatment purposes.

2. Documents for issuing an import permit include:

a) A request for issuance of an import permit according to Form No. 08 prescribed in Appendix I issued together with this Decree;

b) Technical description documents of medical equipment according to the form prescribed in Appendix VIII issued together with this Decree, accompanied by technical documents and user manuals of the medical equipment;

c) Certificate of quality management standard compliance of the medical equipment manufacturing facility requesting the import permit;

d) For cases of import for research, an additional certified copy of the decision approving the research project and documentation proving that the product requested for import has been approved for use by the competent authority in the exporting country;

đ) For cases of import for training, an additional original training program and documentation proving that the product requested for import has been approved for use by the competent authority in the exporting country;

e) For cases of import for aid purposes, an additional certified copy of the decision approving the receipt of aid by the competent authority and documentation proving that the product requested for import has been approved for use by the competent authority in the exporting country;

g) For cases of import for personal medical treatment purposes: a physician's designation document consistent with the individual's condition requesting import.

3. Procedure for considering requests for issuance of import permits for medical equipment:

a) After receiving the application documents for issuance of an import permit for medical equipment, the Ministry of Health sends the organization or individual a Receipt of Application Documents according to Form No. 06 prescribed in Appendix IV issued together with this Decree;

b) In cases where there is no requirement to amend or supplement the application documents for issuance of an import permit for medical equipment, the Ministry of Health must conduct an assessment to issue an import permit for medical equipment within 15 working days from the date recorded on the Receipt of Application Documents. If the permit is not issued, a response letter must be sent stating the reasons;

c) In cases where the application documents for issuance of an import permit for medical equipment are not valid, within 5 working days from the date recorded on the Receipt of Application Documents, the Ministry of Health must send a notification letter to the organization or individual requesting the import permit for medical equipment to supplement or amend the documents. The notification letter must specify which documents need to be supplemented and what contents need to be amended;

d) Upon receiving a document requesting supplementation or amendment of the import application documents, the organization requesting the import permit must supplement or amend the documents according to the contents specified in the document and submit them to the Ministry of Health. The receipt date of the supplemented or amended documents is recorded on the Receipt of Application Documents;

If the organization or individual requesting the import permit for medical equipment has supplemented or amended the documents but not in accordance with the requirements, the Ministry of Health will notify the organization or individual to continue completing the documents;

After 60 days from the date the Ministry of Health issues a document requesting supplementation or amendment, if the organization does not supplement or amend the documents, the procedure for requesting an import permit must be restarted from the beginning.

đ) If there are no further requirements for supplementation or amendment, the Ministry of Health is responsible for issuing the import permit for medical equipment as stipulated in point b of this clause. The import permit will be sent to the organization or individual requesting importation and the customs authority.

Article 43. Documents for Application to Obtain a Free Circulation Certificate for Medical Devices Produced Domestically

1. Documents for Application to Obtain a Free Circulation Certificate for Medical Devices that Have Not Yet Been Registered for Circulation:

a) A request for issuance of a free circulation certificate according to Form No. 11 prescribed in Appendix I attached to this Decree;

b) Documents as stipulated in Article 22 for Class A medical devices or as stipulated in Article 26 for Class B, C, and D medical devices.

2. Documents for Application to Obtain a Free Circulation Certificate for Medical Devices must comply with the requirements stipulated in Article 23 for Class A medical devices or as stipulated in Article 28 for Class B, C, and D medical devices.

3. Documents for Application to Obtain a Free Circulation Certificate for Medical Devices that Already Have a Registration Number: A request for issuance of a free circulation certificate according to Form No. 12 prescribed in Appendix I attached to this Decree.

Article 44. Authority and Procedures for Issuance, Reissuance, and Revocation of Free Circulation Certificates

1. The Minister of Health shall be responsible for issuing, reissuing, and revoking free circulation certificates for medical devices.

2. Procedures for issuing, reissuing, and revoking free circulation certificates shall be carried out in accordance with the Government's regulations on issuing free circulation certificates.

 

Section 3

RIGHTS AND OBLIGATIONS OF ORGANIZATIONS AND INDIVIDUALS PARTICIPATING IN THE PURCHASE AND SALE OF MEDICAL DEVICES

 

Article 45. Rights of Medical Device Purchase and Sale Entities

1. Requesting the seller to provide complete information and traceability records, warranty documentation for medical devices.

2. Requesting organizations and individuals involved in importing, distributing, and using products to cooperate in recalling and handling defective medical devices.

3. Requesting the owner of the registration number to fulfill their warranty obligations for medical devices.

4. Being informed by the registration number owner about defective medical devices.

5. Other rights as prescribed by law.

Article 46. Obligations of Medical Device Purchase and Sale Entities

1. Implementing internal control measures to maintain the quality of medical devices as specified by the registration number owner.

2. Providing users with complete and timely information on:

a) Instructions for using medical devices; conditions ensuring safety, storage, calibration, inspection, maintenance, and repair of medical devices;

b) Notifications regarding defective medical devices.

3. Maintaining records to track medical devices and conducting traceability and recall procedures as prescribed in this Decree.

4. Promptly notifying the registration number owner and state management agencies of cases involving defective medical devices.

5. Adhering to legal provisions and decisions regarding inspections and examinations by competent state authorities.

6. Other obligations as prescribed by law.

 

Chapter VI

MEDICAL DEVICE SERVICES

 

Section 1

TECHNICAL ADVICE ON MEDICAL DEVICES

 

Article 47. Conditions for Providing Technical Advisory Services on Medical Devices

1. The provision of technical advisory services for compiling lists and configuring technical features of medical devices must be conducted by individuals who have been issued a certificate of training in technical advisory services for medical devices.

2. Conditions for individuals providing technical advisory services on medical devices:

a) Having a bachelor’s degree or higher in engineering or medicine/pharmacy;

b) Having at least five years of direct work experience in medical device technology at a medical device facility;

c) Having been assessed and recognized as qualified to provide technical advisory services for medical devices by a training institution according to the training program issued by the Ministry of Health.

3. An advisor may only provide technical advice on medical devices after being issued a receipt of acceptance of the application for qualification to provide technical advisory services for medical devices by the Ministry of Health as stipulated in point b, Clause 2, Article 48 of this Decree.

Article 48. Documents and Procedures for Announcing Sufficient Conditions to Provide Technical Consultation on Medical Equipment

1. The documents for announcing sufficient conditions to provide technical consultation on medical equipment include:

a) A request document for announcing sufficient conditions to provide technical consultation according to Model No. 09 prescribed in Appendix I issued together with this Decree;

b) Certified copies of diplomas and certificates as stipulated in point a and point c, Clause 2, Article 47 of this Decree;

c) A confirmation of working period according to the model prescribed in Appendix III issued together with this Decree.

2. Procedures for announcing sufficient conditions to provide technical consultation on medical equipment:

a) Before providing technical consultation on medical equipment, the person requesting to announce sufficient conditions to provide technical consultation on medical equipment shall be responsible for submitting the documents specified in Clause 1 of this Article to the Ministry of Health;

b) Upon receiving complete and valid documents, the Ministry of Health will issue a receipt for the submission of documents to the person announcing the conditions according to Model No. 07 prescribed in Appendix IV issued together with this Decree;

c) Within three working days from the date recorded on the receipt for the submission of documents, the Ministry of Health shall be responsible for publicly disclosing on its electronic portal the following information: name, address, contact phone number of the consultant; scope of technical consultation on medical equipment and the documents for announcing sufficient conditions to provide technical consultation on medical equipment.

3. During the course of operation, the consultant must re-perform the procedures for announcing sufficient conditions to provide technical consultation if there is any change related to the previous announcement documents.

Section 2

INSPECTION AND CALIBRATION OF MEDICAL EQUIPMENT

 

Article 49. Principles for Implementing Inspection and Calibration of Medical Equipment

1. Medical equipment must be inspected according to the provisions of laws on product quality, and calibrated according to the manufacturer's regulations, except in cases provided for in Clause 2 of this Article.

2. The inspection and calibration of medical equipment that are measuring instruments or radiation devices shall be carried out according to the provisions of laws on metrology and atomic energy.

3. The inspection of medical equipment must be conducted by an entity that has announced sufficient conditions to perform inspection and calibration services for medical equipment.

4. The calibration of medical equipment must be performed by an entity that has announced sufficient conditions to perform inspection and calibration services for medical equipment or by the warranty entity of the medical equipment circulation number owner.

Article 50. Conditions for Entities Providing Inspection and Calibration Services for Medical Equipment

1. Personnel Conditions:

There must be at least two technical staff members (civil servants or employees with a term of at least twelve months or indefinite-term employees) meeting the following requirements:

a) Having a degree of at least a college level in a technical field or a medical or pharmaceutical field;

b) Having professional qualifications appropriate to the type of medical equipment they are assigned to inspect or calibrate.

2. Conditions regarding infrastructure and equipment:

There must be a testing laboratory. The testing laboratory must have a certificate confirming it meets national standards for laboratory capacity and calibration TCVN ISO/IEC 17025 or international standard ISO/IEC 17025 (hereinafter referred to as the Certificate of Compliance for Testing and Calibration Standards).

3. An entity may only inspect and calibrate medical equipment after being issued a receipt for the submission of documents announcing sufficient conditions for inspection and calibration according to Clause 2, Article 52 of this Decree.

Article 51. Documents for announcing qualification for calibration and verification

1. Documents for announcing qualification for calibration and verification:

a) A request for announcement of qualification according to Model No. 10 prescribed in Appendix I issued together with this Decree;

b) A personnel declaration form according to the model prescribed in Appendix II issued together with this Decree;

c) Certificate of compliance with testing and calibration standards that remain valid at the time of announcement.

2. Requirements for documents for announcing qualification for calibration and verification:

a) The application for announcing qualification for calibration and verification shall be compiled into one set, with clear print and arranged in accordance with the order specified in Clause 1 of this Article; there shall be separation between documents, cover page, and list of documents;

b) For the Certificate of compliance with testing and calibration standards: submit the original or certified copy or confirmed copy by the entity announcing qualification for calibration and verification.

In case of submitting a confirmed copy by the entity announcing qualification for calibration and verification, the original must be presented for comparison when submitting the documents or provide source data for the agency receiving the documents to verify the validity of these documents.

If the Certificate of compliance with testing and calibration standards is not in English or Vietnamese, it must be translated into Vietnamese. The translation must be certified in accordance with the provisions of the law.

Article 52. Procedures for announcing qualification for calibration and verification

1. Before conducting calibration and verification of medical equipment, the head of the calibration and verification facility has the responsibility to send the documents stipulated in Clause 1 of Article 51 of this Decree to the Ministry of Health.

2. Upon receipt of complete and valid documents, the Ministry of Health will issue the Calibration and Verification Qualification Announcement Receipt Form according to Model No. 08 prescribed in Appendix IV issued together with this Decree to the entity making the announcement.

3. Within three working days from the date recorded on the Receipt Form, the Ministry of Health is responsible for publicly disclosing on its electronic portal the following information: name, address, phone number of the calibration and verification facility; scope of calibration and verification and the documents for announcing qualification for calibration and verification.

4. During operation, the calibration and verification facility must re-perform the procedures for announcing qualification for calibration and verification if there is any change related to the previous announcement documents.

 

Chapter VII

INFORMATION AND LABELS OF MEDICAL EQUIPMENT

 

Article 53. Information on medical devices

1. Information about medical equipment aims to guide the rational and safe use of medical equipment for healthcare staff and users of medical equipment.

2. Information about medical equipment must be comprehensive, objective, accurate, truthful, easy to understand, and not misleading.

3. Responsibilities for providing information about medical equipment are as follows:

a) The owner of the serial number and the entity selling medical equipment have the responsibility to disclose information about the risk level and other relevant information regarding the use of medical equipment;

b) Healthcare facilities have the responsibility to disseminate information about medical equipment within their premises;

c) Healthcare staff have the responsibility to inform patients about the risk level of using Class C and D medical equipment;

d) Medical equipment management agencies have the responsibility to disclose 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 a system of information about medical equipment.

Article 54LABELS OF MEDICAL EQUIPMENT

1. Labeling of medical equipment shall be carried out in accordance with the provisions of Government Decree No. 89/2006/NĐ-CP dated August 30, 2006, on product labels and must include the following contents:

a) Name of the medical equipment;

b) Serial number of the medical equipment;

c) Name and address of the owner of the serial number of the medical equipment;

d) Origin of the medical equipment;

đ) Date of manufacture or expiration date. The date of manufacture or expiration date must clearly state the day, month, year or month, year.

e) Batch number or serial number of the medical equipment;

g) Instructions for accessing information about warranty service providers, user guides, technical documents for repair and maintenance as stipulated in Clause 2 of Article 17 of this Decree.

2. Imported medical equipment into Vietnam whose label does not display or insufficiently displays the contents as prescribed in Clause 1 of this Article must have an additional label displaying the mandatory contents in Vietnamese while retaining the original label of the product.

Chapter VIII

MANAGEMENT AND USE OF MEDICAL EQUIPMENT AT HEALTHCARE FACILITIES

 

Article 55. Principles for Management and Use of Medical Equipment

1. The management and use of medical equipment must be in accordance with their intended purposes, functions, and regulations, ensuring economy and effectiveness.

2. Inspection, maintenance, repair, testing, and calibration must comply with the manufacturer's regulations, except where laws provide otherwise regarding testing and calibration.

For medical equipment with strict requirements for occupational safety and health, in addition to complying with the inspection, maintenance, repair, testing, and calibration regulations stipulated in this Decree, they must also comply with the regulations on occupational safety and health.

3. Full records about medical equipment must be established, managed, and stored; timely and complete accounting of medical equipment in terms of physical items and value must be conducted according to current laws on accounting, statistics, and other relevant laws; ensure funding for tasks as prescribed in Clause 2 of this Article.

4. Be subject to inspection, examination, and supervision by competent authorities responsible for managing medical equipment.

Article 56. Management and Use of Medical Equipment in State Health Facilities

In addition to implementing the management and use of medical equipment as prescribed in Article 55 of this Decree, state health facilities must manage medical equipment in accordance with the following provisions:

1. Medical equipment in state health facilities shall be managed and used in accordance with the laws on the management and use of state assets.

2. Publicize the management and use system of medical equipment.

3. Implement investment and procurement of medical equipment in accordance with the principles:

a) Suitability with the functions, tasks, needs of the unit, and in compliance with current laws on bidding;

b) Encourage the use of domestically produced medical equipment. For domestically produced medical equipment that has been announced by the Ministry of Health as meeting quality usage requirements and supply capacity, the tender documents and request documents must specify that the bidder cannot offer imported medical equipment.

Article 57. Rights and Responsibilities of Health Facilities in Managing and Using Medical Equipment

1. Health facilities have the following rights:

a) Request the owner of the circulating number to perform regular maintenance within the warranty period;

b) Request the seller to provide technical documentation of the medical equipment;

c) Accept used medical equipment for scientific research purposes and guidance on using and repairing medical equipment.

2. Health facilities have the following responsibilities:

a) Operate medical equipment in accordance with the instructions of the medical equipment owner;

b) Regularly maintain, test, and calibrate medical equipment in accordance with the instructions of the medical equipment owner or as prescribed by law;

c) Participate in testing and evaluating the quality of medical equipment;

d) Report cases of faulty medical equipment and other information as required by competent state authorities.

 

Chapter IX

ANNOUNCEMENT AND ONLINE REGISTRATION

 

Article 58. Cases for Announcement, Registration, and Application for Online Permits

1. Announcement of eligibility for classification of medical equipment.

2. Announcement of eligibility for production of medical equipment.

3. Announcement of standards applicable to medical equipment.

4. Registration for circulation of medical equipment.

5. Announcement of eligibility for trading in medical equipment.

6. Announcement of eligibility for technical consultation on medical equipment.

7. Announcement of eligibility for testing and calibration of medical equipment.

8. Application for import permit for medical equipment.

9. Application for free circulation certificate for domestically produced medical equipment.

Article 59. Requirements for online publication, registration, and permit application files

An online publication, registration, permit application, or free circulation certificate application file (hereinafter referred to as the registration file) shall be considered valid when it meets the following requirements:

1. The file must contain all required documents, with each document fully declared according to regulations applicable to paper-based files and converted into electronic text format. The name of the electronic document must correspond to the type of document in the paper-based file.

2. All information for publication, registration, and permit application must be entered completely and accurately based on the information in the electronic documents.

Article 60. Online Publication Procedures

1. The legal representative declares information, uploads electronic documents, confirms with a public digital signature, and pays fees online through the Ministry of Health's or the Department of Health’s e-government portal.

2. After completing the submission of the online registration file, the legal representative will receive an online registration file receipt.

3. The agency receiving the online registration file shall process administrative procedures corresponding to the registration file as stipulated in this Decree.

4. The result of the online administrative procedure is an electronic document bearing the digital signature of the agency receiving the file and has the same legal effect as the result of an administrative procedure processed through traditional methods.

Article 61. Storage of Online Registration Files

1. In cases where online registration is carried out, the organization or individual making the announcement must store the registration file in paper form.

2. If any documents in the registration file specified in Clause 1 of this Article are lost or damaged, the registration entity shall notify the receiving agency in writing, complete the file again, and notify the receiving agency in writing after completing the file, updating the file upon the receiving agency's consent.

3. Within 35 days from the date of receiving notification about the loss of the file, if the registration entity does not provide a written notice that the file has been completed, the receiving agency shall be responsible for:

a) Removing all published information on the e-government portal related to the entity performing medical equipment classification, medical equipment manufacturing entities, medical equipment trading entities, technical advisors for medical equipment, calibration and verification entities for medical equipment, and medical equipment serial numbers.

b) Revoking the serial number and import permit for medical equipment.

4. The registration entity may not continue operations, and medical equipment may not be circulated from the time the receiving agency removes the information as provided in Clause 3 of this Article.

Chapter X

IMPLEMENTATION

 

Article 62. res Responsibilities of the Ministry of Health

The Ministry of Health is responsible before the Government for managing medical equipment and has the following tasks and powers:

1. Submitting to the Government and the Prime Minister for issuance, or issuing within its authority, legal normative documents, national technical standards, strategies, policies, and plans regarding medical equipment.

2. Directing and organizing the implementation of legal normative documents, strategies, policies, and plans concerning medical equipment.

3. Organizing information dissemination and communication on medical equipment.

4. Organizing training and capacity building for human resources involved in medical equipment work.

5. Publicly posting on the Ministry of Health’s e-government portal information on:

a) Winning bid prices for medical equipment purchases by state healthcare facilities nationwide;

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

6. Conducting inspections, investigations, handling complaints and reports, and dealing with violations of laws in the field of medical equipment.

7. International cooperation in the field of medical equipment.

Article 63. Responsibilities of the Ministry of Science and Technology res 1. Issue the list of medical equipment that are measuring instruments requiring sample approval, inspection, and calibration after obtaining the agreement of the Ministry of Health.

2. Take the lead or cooperate with the Ministry of Health in establishing national standards for medical equipment; inspect and check the quality of medical equipment that are measuring instruments and radiation devices.

Article 64. Responsibilities of the Ministry of Finance

1. Guide the management of state-owned assets which are medical equipment at state-owned healthcare facilities after receiving the opinion of the Ministry of Health.

2. Specify the detailed management and use of fees and charges related to the field of medical equipment according to the laws on fees and charges.

Article 65. Responsibilities of the Provincial People's Committee

Article 651. Be responsible for managing activities related to the business and use of medical equipment within the province.

2. Organize information dissemination about medical equipment within the province.

3. Organize training for human resources working in medical equipment within the province.

4. Publicly post on the provincial people's committee's website and send to the Ministry of Health information regarding:

a) The winning bid prices for purchasing medical equipment by state-owned healthcare facilities within the province;

b) The list of medical equipment that have been recalled from circulation within the province.

5. Inspect, investigate complaints and accusations, and handle violations of the law in the field of medical equipment within the province.

Article 66. Responsibilities of organizations and individuals engaged in the business of medical equipment

1. Organizations and individuals engaged in the business of medical equipment must be responsible for the safety and quality of the medical equipment they sell.

2. The owner of the circulating number shall be responsible for:

a) Implementing the announcement of applicable standards or registration for circulation of medical equipment in accordance with this Decree;

b) Establishing and maintaining a warranty facility for medical equipment or signing a warranty contract with a medical equipment warranty facility;

c) Maintaining records to track medical equipment and conducting traceability of medical equipment in accordance with this Decree, except for single-use medical equipment as defined by the owner of the medical equipment;

d) Providing full and accurate product information on labels and accompanying documents for medical equipment in accordance with the law on product labeling and this Decree;

đ) Timely warning about risks affecting user health and the environment; providing preventive measures for sellers and consumers; supplying information on transportation, storage, preservation, and use of medical equipment;

e) Promptly stopping circulation, notifying relevant parties, and taking measures to address, rectify, or recall defective medical equipment in accordance with this Decree. In cases where destruction is used as a remedy, the destruction of medical equipment must comply with environmental protection laws, relevant laws, and the party must bear all costs associated with the destruction;

g) Adhering to legal regulations and decisions on inspections and checks by competent authorities;

h) Compensating losses in accordance with the law when medical equipment is defective;

i) Ensuring that the following documents remain valid during the period of circulation:

- Certificate of compliance with quality management standards for medical equipment manufacturing facilities;

- Free Circulation Certificate for imported medical equipment classified as types B, C, and D;

- Power of Attorney, except in cases stipulated in point a, Clause 1, Article 21 of this Decree;

- Confirmation of Warranty Conditions.

3. The representative office of the owner of the circulating number must fully perform the obligations specified in Clause 2 of this Article.

k) Other obligations as prescribed by law.

3. The representative office of the circulating number owner shall fully perform the obligations as prescribed in Clause 2 of this Article.

 

Chapter XI

IMPLEMENTING PROVISIONS

 

Article 67. Effective Date

1. This Decree takes effect from July 1, 2016.

2. Clause 10 of Article 12 of Decree No. 89/2006/NĐ-CP dated August 30, 2006 of the Government on product labels shall cease to be effective from the date this Decree takes effect.

Article 68. Transitional Provisions

1. Medical device manufacturing facilities that were operating before the date this Decree takes effect may continue their production activities but must complete the announcement of sufficient production conditions before July 1, 2017. Specifically regarding the quality management system: medical device manufacturing facilities must complete the implementation of the ISO 9001 quality management system before January 1, 2018 and the ISO 13485 quality management system before January 1, 2020.

2. Trading establishments that were operating before the date this Decree takes effect may continue their operations but must complete the procedures for announcing sufficient trading conditions as stipulated in this Decree before January 1, 2017.

3. Organizations and individuals providing medical device services that were operating before the date this Decree takes effect may continue their operations but must complete the request for announcement of sufficient technical consulting conditions for medical devices or announcement of sufficient inspection and certification conditions before July 1, 2017.

4. Medical devices that were produced in Vietnam or imported into Vietnam before the date this Decree takes effect may continue circulation until they are liquidated according to the provisions of Clause 1 of Article 22 of the Law on Management and Use of State Property or until the expiration date stated on the registration certificate for circulation.

5. The issuance of import permits for medical devices or registration numbers for medical devices manufactured domestically or in vitro diagnostic reagents shall be carried out according to current laws until the expiration date specified in Clause 6 of this Article and shall have the following validity:

a) Import permits for Class A medical devices shall be valid until June 30, 2017, and for Class B, C, and D medical devices until December 31, 2017, except as provided in Clause 1 of Article 42 of this Decree.

b) Registration numbers for medical devices manufactured domestically or in vitro diagnostic reagents shall be valid until the expiration date stated on the registration certificate for circulation.

6. Acceptance of standard application declaration files for Class A medical devices will begin on January 1, 2017, and the acceptance certificates for such declarations will take effect from July 1, 2017; acceptance of registration files for Class B, C, and D medical devices will begin on July 1, 2017, and registration numbers for these medical devices will take effect from January 1, 2018.

7. Labels of medical devices that were produced in Vietnam or imported into Vietnam before the provisions of Clause 5 of this Article took effect may continue to be used until the end of the product's shelf life, until they are liquidated according to the provisions of Clause 1 of Article 22 of the Law on Management and Use of State Property, or until the expiration date stated on the registration certificate for circulation.

Article 69. Responsibility for guidance and implementation 2. The Ministers, Heads of ministerial-level agencies, Heads of government agencies, Chairpersons of provincial People's Committees under the central government, and related agencies, organizations, and individuals shall be responsible for implementing this Decree./.

1. The Minister of Health shall be responsible for guiding, organizing, and supervising the implementation of this Decree.

2. The Ministers, Heads of ministerial-level agencies, Heads of government-attached agencies, Chairpersons of provincial People's Committees under central cities, and related agencies, organizations, and individuals are responsible for implementing this Decree./.