PFDA held a public hearing about updated draft for the In-vitro diagnostic (IVD) medical device regulation and registration in the Philippines including discussion on transition period and implementation timeline.
More PFDA released draft document of the updated guidelines for in-vitro diagnostic medical devices (IVD) certification. This new regulation will conform to the risk-based classification of the ASEAN medical device directive (AMDD). A tentative list of registrable IVDs together with a revised set of requirements to register COVID-19 Test Kits was also released on a separate document.
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