The ASEAN Medical Device Directive (AMDD) has been signed by all Member States with the general provisions as follows:
- Only medical devices which conform to the provisions in the AMDD and its Annexes may be placed on the markets of that Member State. (Annexes comprise of Essential Principles of Safety and Performance of Medical Devices, Risk Classification Rules for In Vitro Diagnostic and Non-In Vitro Diagnostic Medical Devices, Common Submission Dossier Template (CSDT), Post Marketing Alert System (PMAS) Requirements, Declaration of Conformity, Labeling Requirements, and Clinical Investigation.)
- Such medical devices shall be registered to ensure their safety and efficacy by which the person responsible for placing the medical devices in that Member State or the authorized representative shall provide a CSDT to the Regulatory Authority for review and approval prior to manufacture and importation. The extent of the CSDT depends on the risk assessment of such medical devices.
- The person(s) responsible for placing the medical devices in that Member State must be registered with the Regulatory Authority. This includes the authorized representative and all persons involved in the supply chain, e.g., manufacturer, importer, distributor, seller dealer.
The AMDD was agreed to be enforced by January 2015. However, the Member States are adjusting their rules and regulations to be aligned with the AMDD, hence, the AMDD has not yet been fully implemented.