Decision 166/QD-BYT: Issuing the “Criteria, Principles for Evaluating the Common Submission Dossier Template (CSDT) for Medical Devices in accordance with ASEAN regulations, applicable to medical devices other than in vitro diagnostic medical devices.” Detailed content can be found in Appendices I, II, III attached to this Decision.
This Decision shall be validated on January 22, 2024.
Download here:
https://medgate.vn/wp-content/uploads/2024/02/QUyet-dinh-166_QD-BYT_.pdf