The Malaysian ministry of health (MoH)’s Medical Device Authority (MDA) is currently working on several new guidances, including one for manufacturers of rehabilitation and disability products; and another on the circulation in the market of COVID-19 self-tests, which are now allowed to be conditionally approved.
Malaysia, Vietnam And Philippines Report Regulatory Compliance Progress And Pain Points
ASEAN member states’ transition to AMDD and certificate renewals are stirring much debate locally
The latest Asian Regulatory Discussions heard about Malaysia’s five-year device certificate renewal concerns, Vietnam industry’s suggestion for device fast-task approval routes, and the Philippines industry’s transition needs as the country’s new AMDD-based regulatory system gets up and running. Also: device news from Singapore and Thailand.

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