Requirements for application for issuance of a new registration number of class-c or class-d medical devices in Vietnam

Requirements for application for issuance of a new registration number of class-c or class-d medical devices in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. Cases of new issuance of  new registration number of class-c or class-d medical devices in Vietnam

According to Clause 1, Article 29 of Decree 98/2021/ND-CP, a new registration number shall be issued in the following cases:

- The medical device does not have any registration number.

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

+ A change in the product owner; class of the medical device; category, intended purposes or indications for use; quality standards; addition of factory or product code;

Raw materials that affect the functions of IVD medical device or disposable medical device; concentration, content, composition of raw materials that are active ingredients incorporated in the medical device to support in medical treatment;

+ A change other than those specified in Clause 7 Article 32 of Decree 98/2021/ND-CP.

2. Requirements for application for issuance of a new registration number of class-c or class-d medical devices in Vietnam

Specifically, in Article 31 of Decree 98/2021/ND-CP, the requirements for application for issuance of a new registration number of class-c or class-d medical devices in Vietnam include:

(1) Requirements for some documents included in the application for registration:

- 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.

- 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.

- 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.

- 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.

- 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 Decree 98/2021/ND-CP:

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

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

- With regard to the document specified in Point c Clause 4 Article 30 of Decree 98/2021/ND-CP: 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.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE