A medical device that wants to be circulated on the market must be registered and granted a circulation license. Currently, medical devices of class A and B carry out the declaration of applicable standards according to the provisions of Decree 98/2021 ND-CP. In this article, let’s learn more about the latest circulation license for medical devices of class A and B in 2024 with Medgate.

Circulation license for medical devices class A, B 

The license to circulate medical devices of class A and B is a declaration of applicable standards issued by a competent authority, ensuring that a medical device meets the prescribed standards.

Enterprises must declare the applicable standards of medical devices of class A and B to the Department of Health where the business headquarters is located according to the provisions of Decree 98/2021 ND-CP.

Accordingly, the dossier announcing the standards for medical devices of class A and B issued by the Department of Health clearly states the applicable standard announcement number, the date of announcement of the applicable standard and other relevant information.

Sample dossier for declaring standards for applying medical device class A, B

Application form for publication of standards for applying medical device classs A, B

To register to announce applicable standards for medical device of class A and B, enterprises need to prepare a dossier to announce applicable standards including:

• Document announcing applicable standards of medical devices of class A, B.
• ISO 13485 quality management certification valid at the time of application.
• Authorization letter from the owner of the medical device to the organization that publishes the applicable standards is still valid at the time of application submission.
• Certificate of eligibility for warranty issued by the owner of the medical device.
• Documents summarizing technical descriptions of medical devices in Vietnamese, accompanied by technical documents describing functions and technical parameters. issued by the owner of the medical device .
• For reagents, calibrators, and in vitro control materials: technical documents in Vietnamese with documents on raw materials, product safety, manufacturing processes, clinical and preclinical research reports including stability reports.
• Certificate of conformity according to regulations or product standards published by the owner of the medical device .
• Particularly for domestically produced medical device, the assessment results of chemical, physical, microbiological parameters and other parameters must be supplemented by a qualified facility according to the provisions of law on conformity assessment or a Certificate of quality assessment issued by a competent authority of Vietnam for in vitro diagnostic medical device . The assessment results must be consistent with the standards announced by the owner .
• User manual of medical device
• Label sample to be used when circulating in Vietnam
• Free circulation certificate valid at the time of application for imported medical device

Applicable standard announcement process:

Step 1: Prepare application documents for publication of applicable standards

Step 2: The facility submits the declaration dossier to the Department of Health where the business headquarters is located.

Step 3: Receive results – The local Department of Health is responsible for posting the Announcement Number of applicable standards for medical devices of class A and B publicly on the Electronic Information Portal on medical device management together with the dossier announcing the applicable standards

Changes in registration of standards applicable to medical device classs A and B

Business establishments shall register medical devices according to the provisions of Decree 98/2021/ND-CP. This Decree takes effect from January 1, 2022. Accordingly, Decree No. 36/2016/ND-CP and Decree No. 169/2018/ND-CP has expired from the effective date of Decree 98/2021 ND-CP.

Some changes in the registration of standards applicable to medical device classs A and B:

Content changes	Decree 36/2016/ND-CP and Decree 169/2018/ND-CP	Decree 98/2021 ND-CP
Circulation number of medical device	Number of receipts for standard declaration dossiers applicable to class A medical device Registration certificate number for medical devices of class B, C, D.	Number of published standards applicable to medical device class A, B Registration certificate number for medical device of class C, D
Validity period of medical device circulation number	For class A medical device, the circulation number is valid indefinitely. The circulation number of medical devices of class B, C, D is valid for 05 years from the date of issue.	No time limit for medical device class A, B, C and D except in some special cases.
Application standard declaration file	Need a medical device classification	Not required
Changes in circulation	The owner of the circulation number is responsible for notifying the Department of Health of any changes within 10 working days.	Deadline for notifying the Department of Health of changes within 05 working days. The content of the change is supplemented with the following items: Reduction of production facilities, class, and product codes.

 

To learn more about medical device registration and the process to issue a medical device 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 device.