Methods of registration of class-c or class-d medical devices in Vietnam

Methods of registration of class-c or class-d medical devices in Vietnam (Internet image)

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

1. What is the registration number of a medical device?

According to Clause 1, Article 21 of Decree 98/2021/ND-CP, the registration number of a medical device is:

- The number of declaration of applied standards of Class-A or Class-B medical device;

- The number of certificate of registration of Class-C or Class-D medical device.

2. Methods of registration of class-c or class-d medical devices in Vietnam

2.1. New issue of registration number 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.

2.2. Quick issuance of a new registration number in Vietnam

Cases of quick issuance of a new registration number:

- The medical device has been granted the CFS (Certificate of Free Sale) or marketing authorization by one of the following authorities or countries:

+ U.S. Food and Drug Administration (FDA);

+ Australian Therapeutic Goods Administration (TGA);

+ Health Canada, Japanese Ministry of Health;

+ Labour and Welfare (MHLW) or Pharmaceuticals and Medical Devices Agency;

+ EU state members, UK, Switzerland, National Medical Products Administration (NMPA) - China, Ministry of Food & Drug Safety (MFDS) - Korea;

+ Other CFS issuing authorities recognized by Vietnam (hereinafter referred to as “reference countries”);

- The medical device has been granted the import license or registration number or certificate of registration in the commercial form in Vietnam, unless revoked before the effective date of Decree 98/2021/ND-CP;

(Clause 2, Article 29 of Decree 98/2021/ND-CP)

2.3. Issuance of emergency use registration number in Vietnam

According to Clause 3, Article 29 of Decree 98/2021/ND-CP,  the issuance of emergency use registration number for medical devices to serve epidemic prevention and control, and disaster recovery purposes in emergency cases included in the relevant List issued by the Minister of Health and in one of the following cases

(i) The medical device has been placed on the market or granted registration number for emergency use in one of the reference countries;

(ii) The medical device is included in the list of products for emergency use announced by the World Health Organization (WHO);

(iii) The medical device is included in the list of common products announced by the EU Health Security Committee (EUHSC);

(iv) The medical device has been granted the registration number or import license in the commercial form in Vietnam, unless revoked before the effective date of this Decree;

(v)  The medical device is domestically manufactured in the form of technology transfer in one of the cases specified in (i), (ii), (iii) or (iv);

(vi) The medical device is domestically manufactured in the form of processing in one of the cases specified in (i), (ii), (iii) or (iv).

Thanh Rin

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