Requirements for application for issuance of a new medical device registration number of Class C, D in Vietnam

According to Article 31 of Decree 98/2021/ND-CP (Effective January 1, 2022), the requirements for application for issuance of a new medical device registration number of Class C, D in Vietnam are as follows: 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Best Regards!