Medical devices need circulation number, circulation registration number, circulation registration certificate and other documents as prescribed by current law when circulating on the market. In this article, MEDGATE will introduce to you the form of circulation resistration number for medical devices that manufacturers or importers need for their products to be circulated in the Vietnamese market.

1. Definition of medical device’s circulation registration numbers

According to Clause 1, Article 21 of Decree 98/2021/ND-CP, the circulation registration number of medical equipment is the number of the applicable standard announcement (for medical devices of type A, B) or the number of the circulation registration certificate (for medical devices of type C, D).

The classification of medical devices is also stipulated in Article 4 of this Decree, accordingly, depending on the level of risk, medical equipment can be divided into 4 types as follows:

Type	Risk level	Examples
A	Low	Medical trays, gloves, stretchers,…
B	Medium low	Blood pressure monitor, electrocardiograph, ultrasound machine,…
C	Medium high	Ventilators, magnetic resonance imaging (MRI) systems, viral DNA quantification kits,…
D	High	ECMO machine, blood filtration device, artificial heart valve,…

Examples of Medical devices

2. Application for issuance of TTBYT circulation number

Except for special cases, medical devices must have a circulation registration number when circulating on the Vietnamese market. Depending on the classification of medical equipment, the application for issuance of applicable standards (type A, B medical equipment) or a certificate of free circulation (type C, D medical equipment) requires different types of documents. The manufacturer or the importer of the medical devices is responsible for providing the competent management agency with documents certifying compliance with quality standards, documents describing the technical specifications of the product, a valid circulation certificate for imported medical equipment and other documents specifically required under the content of Decree 98/2021/ND-CP

3. Form of Circulation Resistration Number for Medical devices

After receiving the application for a medical device circulation resistration number, the competent management agency will review the application and issue a certificate of free circulation of the medical device. This form is specified in Form 07, Appendix IV, Circular 10/2023/TT-BYT.

Click here for details: :https://medgate.vn/wp-content/uploads/2024/09/Form-of-Circulation-Resistration-Number-for-Medical-devices.pdf

To learn more about MEDGATE medical equipment registration services , please contact Hotline: 098.546.1894 or Email: medgatevn@gmail.com for free consultation on documentation services and procedures, quote registration for publication and advertising of medical.