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PHILIPPINES: PFDA Released Draft Documents regarding IVD regulation– February 2022

PHILIPPINES: PFDA Released Draft Documents regarding IVD regulation– February 2022

  • 2022-02-18 08:32:17

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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