ASEAN signs off new rules on medical devices but timing uncertain

BANGKOK – ASEAN member States have signed off on the ASEAN Medical Device Directive (AMDD), creating a new set of rules for providers. Only medical devices which conform to the provisions of the AMDD and its Annexes may now be placed in the markets of the Member State.

In a Client Alert, lawyers Baker & McKenzie say that the annexes comprise 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, Labelling Requirements, and Clinical Investigation.
There are a number of other requirements.
B&M says ASEAN originally agreed that the rules would be enforced by January 2015. However, member States are adjusting their rules and regulations to be aligned with the AMDD, so the regulations have not yet been fully implemented. www.bakerandmckenzie.com (ATI).