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PHILIPPINES: PFDA Released FDA Circular No. 2021-002-C Further Extending the Application Period for CMDN for Class B, C, and D Medical Devices – April/May 2023

PHILIPPINES: PFDA Released FDA Circular No. 2021-002-C Further Extending the Application Period for CMDN for Class B, C, and D Medical Devices – April/May 2023

  • 2023-04-24 09:37:45

On March 31, 2023, PFDA has once again extended the application period for one more year for medical device products that were previously considered non-registrable, which currently fall under AMDD risk class B-D. PFDA cites the risk of disrupting the supply chain that may negatively impact the quality of the healthcare system in the country.

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PHILIPPINES: PFDA Shared CMDN Requirement Extension and Drafts for Abridged Route and Emerging COVID-19 products – May 2022

PHILIPPINES: PFDA Shared CMDN Requirement Extension and Drafts for Abridged Route and Emerging COVID-19 products – May 2022

  • 2022-05-26 13:57:18

PFDA extended the CMDN Requirement of Class B-D Non-Registrable products until March 2023. This will allow continue selling of the affected products in the country using a License to Operate as the requirement. In addition, PFDA shared draft regulations pertaining to the earlier released Abridged Route Evaluation and COVID-19 products using new technologies.

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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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