Philippines – Guidelines released for transition in Philippines to ASEAN harmonized requirements

The Food and Drug Administration of the Philippines (FDA) published Circular No. 2021-002, providing guidelines for the full implementation of the Association of Southeast Asian Nations (ASEAN) harmonized technical requirements and outlining procedures for what have previously been non-registrable Class B, C, and D medical devices.

Background on ASEAN harmonization of medical device regulations

Creating a harmonized medical device regulatory framework has been a priority of ASEAN since the early part of last decade, and 2014 yielded the official signing of the ASEAN Medical Device Directive (AMDD) by all 10 member states: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam. The transition to the harmonized framework has developed at varying rates, with Singapore and Malaysia achieving rapid progress while other ASEAN member states lagged behind…