Publication of standards applicable to medical devices of categories A and B in Vietnam

Publication of standards applicable to medical devices of categories A and B in Vietnam

I. Procedures for publication of standards applicable to medical devices of categories A and B in Vietnam:

1. Before selling medical devices of categories A and B on the market, the establishment publising the applicable standards is responsible for submitting the declaration dossier to the Department of Health where its business is located.

2 . When receiving the application file (including the paper certifying that the fee has been paid according to regulations of the Ministry of Finance), the Department of Health in the area where the medical devices business establishment is located shall upload the standard publication number applicable to medical devices of categories A and B, it shall be published on the electronic portal on management of medical devices and the application for publication of applicable standards, except for the documents specified in Clause 5, Article 26 of the Decree No. 98/2021/NĐ-CP.

3. In case of change of owner of medical devices, type of medical devices, type, purpose of use, indications for use; Supplementing production facilities and product codes, the owner of the circulation number is responsible for re-declaring the applicable standards according to the provisions of Decree No. 98/2021/ND-CP.

4. During the circulation of medical devices, the owner of the applicable standard publication number is responsible for making a written notice of the change, enclosed with documents related to the change, and updating such documents on the website. application standard announcement dossiers have been published on the electronic portal on management of medical devices within 05 working days from the date of one of the following changes:
a) Change of address of the owner of the medical devices or the owner of the free sale number of the medical devices;
b) Changing the name of the owner of the circulation or the name of the owner of medical devices;
c) Change one of the information about the name and address of the manufacturing facility of medical devices;
d) Change of packing specifications;
dd) Change of warranty facility;
e ) Change the label, change the instructions for use but do not change the purpose of use, specify the use.
Medical devices manufactured before the date the owner of the standard announcement number applies the notice of change of the label may be circulated with the published information at the time of manufacture;
g) Reducing production facilities, categories and product codes.

II. Free-sale registration number of medical devices of categories A and B in Vietnam.

The free-sale registration number of the medical device of categories A and B is the number of published standards applicable to medical devices of categories A and B;

Free-sale registration number holder is the organization that declares the standards applicable to medical of categories A and B.

Validity of the free-sale registration number: the free-sale registration number of medical devices is valid for an indefinite period.

III. Conditions for sale of medical devices of of categories A and B in Vietnam.

1 . When being circulated on the market, medical devices must satisfy the following conditions:
a) It has been granted the free-sale registration number, marketing authorization number, certificate of registration or import license in accordance with regulations on management of medical devices;
b) Having labels with full information according to current regulations of law on goods labels;
c ) There are instructions for use of the medical devices in Vietnamese;
d) Information about warranty center, conditions and time for warranty, except disposable medical devices defined by the product owner or cases where there are documents proving that the medical device is not under warranty.

2. If the import license is available as prescribed in Points a, b, c, d and dd Clause 1 Article 48 of this Decree, the satisfaction of the condition in Point d Clause 1 of this Article is not required.

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

IV. Conditions for publication of applicable standards for medical devices of categories A and B in Vietnam

1. Conditions for announcing applicable standards  for medical devices of categories A and B:
a) Manufactured at a production facility that has announced its eligibility to produce domestically produced medical devices;
b) Produced at a production facility that has been granted a certificate of ISO 13485 quality management standard and circulated in any country in the world for imported medical devices;
c) Compliant with national technical regulations or standards announced by the manufacturer to apply.

2. Do not allow to repeat procedures applicable standards published or registered for circulation for medical devices in one of the following cases:
a ) Medical devices in the cases where the owner of the medical devices declares that it will no longer produce or is bankrupt or dissolved may continue to be circulated for a maximum period of no more than 24 months.
b) Medical devices is recalled in cases where the organization registering for circulation falsifies the registration dossier and the organization registering for circulation corrects, erases, and changes the content of the circulation number.

3. Do not receive the application for publication of applicable standards or registration for free sale within 12 months from the date of issuance of a decision on revocation of the free-sale registration number for medical devices falling into one of the cases specified in Clause 1 of this Article. Clause 2, Article 38 of this Decree.

IV. Cases exempt from publication of applicable standards

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

2. Medical device imported into Vietnam for the purpose of aid or healthcare Humanitarian or service activities fairs, exhibitions, displays, product introduction or to use for the purpose of gifts gifts, gifts for the medical establishment or individual treatment, personal characteristics or special diagnostic needs of medical facilities.

3. Medical devices that does not have a free sale registration number is imported to meet the urgent needs of disease prevention and control, overcoming the consequences of natural disasters and disasters where other capable medical devices is not available on the market for replace.

4 . Medical devices manufactured in Vietnam for export purposes only or participating in exhibitions, fairs and exhibitions abroad

V. Conditions of organizations entitled to announce standards applicable to medical devices of of categories A and B in Vietnam.

1. Organization names are announced applicable standards or registration for distribution of medical devices include:
a) Enterprises, cooperatives, business households in Vietnam are owners of medical devices;
b) Vietnamese enterprises, cooperatives and business households authorized by the owner of the medical devices;
c) The representative office permanently residing in Vietnam of a foreign trader that is the owner of the medical devices or authorized by the owner of the medical devices.

2. The organization declaring the applicable standards for medical devices must have a warranty facility in Vietnam or must have a contract with a qualified organization to provide warranty for medical devices, except for the following cases: The case of single-use medical devices as specified by the owner of the medical device or with documents proving that there is no warranty.

In case the organization in whose name announces the applicable standards or registers the free sale of medical devices specified at Point c, Clause 1 of this Article, the owner of the medical devices must have a warranty facility in Vietnam or have a contract with a qualified facility to provide warranty for medical devices, except for the case of single-use medical devices as prescribed by the owner of the medical devices or with documents proving that no
warranty. The warranty facility must be certified by the medical devices owner to be qualified to warrant the product.

VI. Dossier for publication of standards applicable to medical devices of categories A and B in Vietnam:

Dossier declaring standards applicable to medical devices of categories A and B includes:
1. Document announcing standards applicable to medical devices of categories A, B.

2. The certificate of ISO 13485 quality management standard is valid at the time of application.

3 . The power of attorney of the medical devices owner for the organization declaring the applicable standard is still valid at the time of application, except for the case specified at Point a, Clause 1, Article 25 of this Decree.

4 . Certificate of eligibility for warranty issued by the owner of the medical devices, unless the medical devices is single-use according to the regulations of the owner of the medical devices or has documents proving that there is not a warranty.

5 . A brief technical description of the medical devices in Vietnamese, accompanied by a technical document describing the functions and technical parameters of the medical devices, issued by the owner of the medical devices.

Particularly for reagents, calibrators, and in vitro control materials: technical documents in Vietnamese together with documents on materials, product safety, production process, and research reports Clinical and preclinical including stability reports.

6. A certificate of conformity according to regulations or a copy of product standards announced by the owner of the medical devices.

Particularly for domestically produced medical devices, the results of assessment of chemical, physical, microbiological parameters and other parameters shall be added because the facility satisfies all conditions in accordance with the law on conformity assessment or Certificate of quality assessment issued by a competent authority of Vietnam for in vitro diagnostic medical devices. Evaluation results must be consistent with the standards announced by the owner of the medical device.

7. User documentation of medical devices.

8. Sample labels will use when circulation in Vietnam of medical devices.

9 . The certificate of free sale is still valid at the time of application for imported medical devices.

VII. Requirements for application standard announcement dossiers for medical devices of categories A and B in Vietnam.

1 . Dossier for publication of applicable standards shall be made into 1 set.

2 . Requirements for a number of papers in the application for publication of applicable standards:
a) For the Certificate of satisfaction of quality management standards: Submit the original or a certified true copy or a copy certified by the organization declaring the applicable standard.
If the Certificate of satisfaction of quality management standards is not in English or in Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.
b) For the power of attorney of the owner of the medical devices and the certificate that the facility is eligible for warranty:
- For domestically produced medical devices: Submit the original or a certified copy;
- For imported medical devices: Submit the consularly legalized copy or a certified copy of the consularly legalized copy.
c) For the standard conformity certificates or written standards that owners of medical devices announced apply: Submit originals or copies certified by the organization whose name announced applicable standards.
If the Standard is not in English or in Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.
d ) For the documentation of use of the devices medical: Submit a Vietnamese version certified by the organization whose name announced applicable standards, together with the original in English by owners of devices medical devices issued for medical devices imports. Where documentation to use in English or Vietnamese language must be translated into Vietnamese. The translation must be certified according to the provisions of law.
dd) For label samples: Submit a sample label certified by the organization declaring the applicable standard. Label samples must meet the requirements of the law on goods labels.
e) For the certificate of free sale: Submit the consularly legalized copy or a certified copy of the consularly legalized copy.
If the certificate of free sale is not in English or in Vietnamese, it must be translated into Vietnamese. The translation must be certified according to the provisions of law.
g) For the results of evaluation of chemical, physical, microbiological parameters and other parameters, issued by an establishment that fully meets the conditions prescribed by the law on conformity assessment or the Certificate of quality assessment; issued by a competent Vietnamese authority for in vitro diagnostic medical devices: Submit the original or a certified copy.

Sources:
- Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on medical devices management.
- Decree No. 07/2023/ND-CP dated March 3, 2023 of the Government on adjusting Decree No. 98/2021/ND-CP

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