On January 2, 2024, the Ministry of Health issued Decision No. 04/QD-BYT regarding The Designation of Units for Assessment of The Common Technical Dossier on Medical Devices According to The ASEAN Regulations.
The decision includes the following contents:
1. The Designation of units to conduct assessments of general technical documentation on medical in accordance with ASEAN regulations.
- For documentation requesting the issuance of circulation numbers for medical that is not in vitro diagnostic medical devices: Institute of Equipment and Health Construction.
- For documentation requesting the issuance of circulation numbers for in vitro diagnostic medical devices: National Testing Institute for Vaccine and Biological Products.
2. The effective date of this decision is January 2, 2024.
Readers download the content below:
– English Version: https://medgate.vn/wp-content/uploads/2023/12/EN_-QD-04-BYT.pdf