ASEAN Medical Device Directive Implementation Updates.
Legal News & Analysis - Asia Pacific - ASEAN - Regulatory & Compliance
27 August, 2019
While local laws of Singapore, Malaysia and Indonesia have fully complied with the ASEAN Medical Device Directive (AMDD), it is encouraging to see more developments of various Member States in ASEAN this year. From the report of the 8th ASEAN Medical Device Committee (AMDC) Meeting and Related Activities – Industry Training Sessions and Public-Private Forum which took place in the Philippines this month, the Philippines will be launching a pilot study (Phase 0) in August 2019. Cambodia and Thailand have partially implemented their national regulations according to the AMDD, while Lao PDR and Myanmar are also in the process of adjusting their national laws to be in line with AMDD despite some challenges.
For background, the AMDD was signed by 10 Member States of the Association of Southeast Asian Nations (Member States) in 2015. The main contents of the AMDD concerning the registration of medical devices include definition and scope, medical device classifications, pre-marketing requirements and Common Submission Dossier Template (CSDT) and technical requirements, labeling requirements, medical device claims, and post-marketing alert system (PMAS). Each Member State has an obligation to undertake appropriate measures to ensure that their national laws align with the AMDD, that necessary technical infrastructures are in place to implement AMDD, and that there is a post-marketing surveillance.
It hopefully will not be long before all Member States are fully in compliance with the AMDD and medical devices can be registered or notified via electronic systems the same way Singapore, Malaysia and Indonesia are doing. This achievement will definitely provide economic and other benefits both directly or indirectly to the medical devices and healthcare industry and to the region as a whole.
To be more specific on Thailand, the following items: definition and scope of medical device, licensing requirements, approval process, listing of medical device, export control, medical device experts, complaint channels, fine rates, and reduce duty for manufacturer and importer, have already been revised to comply with the AMDD. CSDT and PMAS have also been implemented. There are some work in progress regarding adjustment of the medical device classifications using risk assessment basis.
We will monitor status of the progress of the developments and provide updates on any developments.
For further information, please contact:
Peerapan Tungsuwan, Partner, Baker & McKenzie