What are the regulations on the application for declaration of applied standards for class A, B medical device in Vietnam? - Trung Huy (Gia Lai, Vietnam)
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Application for declaration of applied standards for class A, B medical device in Vietnam (Internet image)
Regarding this issue, LawNet would like to answer as follows:
1. What is class A and B medical device?
Class A, B medical device is a type of medical device according to their levels of potential risks related to their designs and manufacture.
Specifically, in Article 4 of Decree 98/2021/ND-CP, there are 4 types of medical device including:
- Class A: Low risk.
- Class B: Low-moderate risk.
- Class C: Moderate-high risk.
- Class D: High risk.
2. Application for declaration of applied standards for class A, B medical device in Vietnam
Specifically, in Article 26 of Decree 98/2021/ND-CP, an application for declaration of applied standards for Class-A or Class-B medical device consists of:
- The declaration of applied standards for Class-A or Class-B medical device.
- An unexpired certificate of conformity with ISO 13485 quality control standards.
- The unexpired letter of authorization given by the product owner to the organization that applies for declaration of applied standards, except the case specified in Point a Clause 1 Article 25 of Decree 98/2021/ND-CP.
- The certificate of eligibility to provide warranty services granted by the product owner, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty.
- A synopsis of technical description of the medical device in Vietnamese, accompanied by technical documents describing functions and specifications of the medical device issued by the product owner.
With regard to in-vitro reagents, calibrators and control materials, the synopsis of technical description in Vietnamese must be accompanied by documents on materials and safety of the product, manufacturing process, pre-clinical and clinical study reports including stability report.
- The certificate of conformity or product standard sheet provided by the product owner.
With regard to domestically manufactured medical devices, the assessment record of chemical, physical and microbiological indicators and other indicators provided by a qualified conformity assessment body in accordance with regulations of law on conformity assessment is required;
If it is an IVD medical device, certificate of quality assessment issued by a competent authority of Vietnam is required. The assessment result must be conformable with the standards declared by the product owner.
- User manual of the medical device.
- A sample of the label for the medical device sold in Vietnam.
- The unexpired CFS (for imported medical devices).
3. Requirements for application for declaration of applied standards for class A, B medical device in Vietnam
A dossier of declaration of standards for application of class A and B medical device must satisfy the following requirements:
- 01 set of application for declaration of applied standards shall be prepared.
- Requirements for some documents included in the application:
+ Certificate of conformity with quality control standards: original copy or certified true copy or copy bearing certification of the declarant.
If the Certificate of conformity with quality control standards is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.
+ Product owner’s letter of authorization and certificate of eligibility to provide warranty:
++ For a domestically manufactured medical device: original copy or certified true copy;
++ For an imported medical device: consularly legalized copy or certified true copy thereof.
+ Certificate of conformity or product standard sheet provided by the product owner: original copy or copy bearing certification of the declarant.
If the product standard sheet is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.
+ User manual of the medical device: Vietnamese copy bearing certification of the declarant, accompanied by English version issued by the product owner, in case of imported medical devices.
If the user manual is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.
+ Sample label: the sample label bearing certification of the declarant. The sample label must meet requirements laid down in regulations of law on labeling of goods.
+ CFS: consularly legalized copy or certified true copy thereof.
If the CFS is not written in English or Vietnamese, it must be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.
+ Record of chemical, physical and microbiological indicators and other indicators provided by a qualified conformity assessment body in accordance with regulations of law on conformity assessment or certificate of quality assessment issued by regulatory authority of Vietnam (for an IVD medical device): original copy or certified true copy.
(Article 27 of Decree 98/2021/ND-CP)
Thanh Rin
- Key word:
- medical device in Vietnam
