The Association of Southeast Asian Nations (ASEAN) is set to introduce the ASEAN Medical Devices Directive (AMDD), a uniform set of regulations that will cover all 10 of its member states. The AMDD will be written based on the Global Harmonization Task Force (GHTF) and various European guidelines, such as the European Medical Devices Directive (MDD 93/42/EEC) and MEDDEVs. All medical devices, including in-vitro diagnostic devices and active implantable devices, will be regulated by the AMDD.
In accordance with the GHTF, medical devices will be subject to a risk-based classification system with four tiers (Classes A through D, in increasing degree of risk). A Common Submission Dossier Template (CSDT), modeled after the GHTF Summary Technical Document (STED), will be required for medical device approval applications. Conformity Assessments, in addition to GHTF and MEDDEV guidelines, will be used to determine whether a given medical device complies with the AMDD. Medical device manufacturers may be able to expedite their device approval applications in ASEAN if their devices already comply with the European Medical Devices Directive.
Despite the establishment of a uniform set of regulations across ASEAN, manufacturers will still be required to register their devices through local authorized representatives (LARs) in every member state. Besides, device manufacturers, LARs, importers and distributors must be registered on Establishment Licenses. Good Distribution Practice (GDP) requirements will also be in place.
ASEAN is accepting opinions on the implementation of the AMDD until August 31, 2012. It is anticipated that the AMDD will be mandatory by 2015 in all ASEAN member states.