ASEAN Medical Device Directive

The regional framework harmonising medical-device regulation across ASEAN member states — covering definitions, risk classification (four classes A–D), essential principles of safety and performance, and the ASEAN CSDT dossier format. Vietnam aligns through Decree 98/2021/NĐ-CP (Article 4 for classification) and Circular 05/2022/TT-BYT (sixteen self-classification rules in Part II of Appendix I). Foreign manufacturers approved in another ASEAN member state still require Vietnamese registration but may use AMDD-aligned dossiers.

• Nghị định 98/2021/NĐ-CP + Thông tư 05/2022/TT-BYT.
• ASEAN harmonisation framework.