ASEAN (Association of Southeast Asian Nations) recently released a draft of the ASEAN Medical Device Directive (AMDD) for comments in August 2012. This draft aims to enhance and harmonize medical device regulations among member countries. ASEAN plans to implement the Directive by December 2014.
The AMDD requires the ASEAN countries to adopt a common format for medical device application dossiers, establish postmarketing surveillance alert systems, and institute uniform medical device classification criteria. The draft AMDD was promulgated by the Medical Device Product Working Group (MDPWG) of ASEAN’s Consultative Committee on Standards and Quality (ACCSQ).
The future ASEAN harmonization of industry and regulatory requirements will help eliminate trade barriers and promote economic development among the ASEAN countries. An integrated regulatory regime will make it easier for Western companies to enter the ASEAN medical device market and register products in Southeast Asian countries. For instance, a manufacturer will be able to use the same dossier for medical device approval in Singapore, Malaysia, Indonesia, etc. For more information on ASEAN regulatory integration on medical devices, please see our webcast: ASEAN Medical Device Harmonization Trends.
Given the discrepancies in current medical device regulations and development levels of regulatory infrastructure among ASEAN countries, the AMDD may not be mandatory or implemented as an actual law. However, member states are required to comply with the general provisions and pass individual laws facilitating the regulatory convergence.