To Comply with ASEAN Standards, Thailand to Categorize Medical Devices Based on Risk

Medical devices in Thailand will be classified in accordance with the risk they pose to patients and the public, under a new categorization system announced by the Ministry of Public Health. The move to create four categories each for both in vitro and non-in vitro medical devices, separated by level of risk from low to high, will bring Thailand into alignment with the standards of The Association of Southeast Asian Nations (ASEAN), of which Thailand is a member. Since 2015, when Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam signed the ASEAN Medical Device Directive, the ten nations have sought to establish uniform requirements for the registration and quality of medical devices.