Vietnam to introduce the Common Submission Dossier Template
The Ministry of Health in Vietnam will officially require the use of the Common Submission Dossier Template (CSDT) for all new class B, C, and D medical device registrations as of 01 January 2022. This requirement was published in Decision No. 2426/QDBYT on 15 May 2021 and came into effect immediately.
The Decision contains a set of guidelines on how to prepare the Common Submission Dossier Template. The guidelines are based on those issued by the regulatory authorities in Singapore and Malaysia; and aim to ensure full compliance with the new requirements being introduced for Vietnam.
The use of the CSDT is a requirement in the application of the ASEAN Medical Device Directive (AMDD) to which Vietnam is a signatory. By introducing the use of the CSDT, the Vietnamese Ministry of Health is aligning the management and supervision of medical devices on a regional and international level.
Implications for medical device manufacturers, local authorized representatives and distributors
As the Decision came into effect immediately, medical device manufacturers and their local authorized representatives are advised to start preparing the CSDT now to be ready to submit registration applications for class B, C and D medical devices as of 01 January 2022.
Of particular interest, is that the new UKCA medical device mark is now officially recognized in Vietnam as having the equivalent status of other Global Harmonized Task Force (GHTF) market authorizations, notably United States, Canada, Australia, European Union and Japan. This means that medical device manufacturers who choose to register in the United Kingdom can now access the Vietnamese medical device market without having to register in one of the GHTF countries first, in order to obtain quicker/fast track/abridged registration.
Also please note that the language for submitting the CSDT is Vietnamese, however certain sections and certain information can be submitted in English or Vietnamese where specified such as for:
- Essential Principles Conformity Checklist
- Medical device description – Materials section
- Summary of Design Verification and Validation Documents
- Risk Analysis
- Manufacturing Information.
For more information
If you have any queries regarding registrations, market authorizations or our services for medical device registration and representation in Vietnam, please click on the button below.
To learn more about registering medical devices in Vietnam click here.
To learn more about the medical device market in Vietnam click here.