The Ministry of Health in Vietnam has issued Decision No. 04/QD-BYT on January 2, 2024, to designate Conformity Assessment Bodies (CAB) for evaluating the Common Submission Dossier Template (CSDT) within the country. According to Decree 98/2021/ND-CP amended by Decree 07/2023/ND-CP, registration of medical devices classified as Class C & D requires adherence to CSDT since 2024.

 

The assessment of CSDT will be carried out by the following organizations:

• •  The Institute of Medical Device and Construction will review CSDT for general medical devices.
• •  The National Institute for Control of Vaccines and Biologicals will scrutinize CSDT for In Vitro Diagnostic (IVD) medical devices.

Once certified by the CAB, applicants can proceed to submit the complete dossier to the Ministry of Health (MoH) to obtain the registration certificate.

 

 

Reference:
Decision No. 04/QD-BYT