In recent years, the demand for medical equipment in medical facilities nationwide has increased in quantity and type to meet the medical examination and treatment needs of the people. A medical device that wants to be circulated on the market must be licensed by the competent health management agency. In this article, let’s learn about the license to circulate medical equipment in Vietnam with Medgate.

Medical device circulation license

A medical device circulation license is a license issued by a health management agency, recognizing that a medical device has been tested for quality, safety and effectiveness, and meets prescribed standards.

The medical device circulation license is a standard announcement applicable to medical devices of type A and B. For medical devices of type C and D, the medical device circulation license is a certificate of registration for circulation of the medical device.

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

– Number of published standards applicable to medical device of type A, B;

– Registration certificate number for medical device of type C, D.

Accordingly, the announcement of applicable standards or the circulation registration certificate clearly states the announcement number of applicable standards and the announcement date for medical equipment of types A and B or the circulation registration certificate number and the date of issue for medical equipment of types C and D.

The circulation number of medical equipment is valid indefinitely, except in some special cases.

Cases exempted from publishing applicable standards and exempted from circulation registration

– Medical equipment is only used for the purposes of research, testing, inspection, testing, quality assessment, training, instruction on use, and repair of medical equipment.

– Medical equipment imported into Vietnam for the purpose of aid or humanitarian medical examination and treatment or to serve fairs, exhibitions, displays, product introductions or to be used as gifts for medical facilities or for personal treatment, specific personal needs or for special diagnostic needs of medical facilities.

– Medical equipment without a circulation number is imported to meet urgent needs for disease prevention and control, overcoming the consequences of natural disasters and catastrophes, and there are no other medical equipment available on the market that can replace it.

– Medical equipment manufactured in Vietnam is only for the purpose of export or participation in exhibitions, fairs and exhibitions abroad.

Which organization is responsible for announcing applicable standards or registering the circulation of medical device?

According to Clause 1, Article 25 of Decree 98/2021 ND-CP , organizations that are allowed to announce applicable standards or register for circulation of medical equipment include the following cases:

– Vietnamese enterprises, cooperatives, and business households are owners of medical equipment;

– Vietnamese enterprises, cooperatives, and business households authorized by the owner of medical equipment;

– Permanent representative office in Vietnam of a foreign trader that is the owner of the medical equipment or is authorized by the owner of the medical equipment.

 

To learn more about medical equipment registration and the process to issue a medical equipment circulation number at MEDGATE , please contact Hotline: 098.546.1894 or Email: medgatevn@gmail.com for advice on document services, procedures, price quotes for registration, circulation announcement, and advertising of medical equipment.