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Global Certification Technical Update

May 2019

May 2019 Updates

Philippines

PHILIPPINES (CDRRHR) – RULES AND REGULATIONS FOR IN-VITRO DIAGNOSTIC (IVD) MEDICAL DEVICE BASED ON ASEAN HARMONIZED TECHNICAL REQUIREMENTS

Proposed date of entry into force: This Order shall take effect 15 days after its publication in a national newspaper of general circulation.

The Department of Health through the Food and Drug Administration – Center for Device Regulation, Radiation Health and Research (CDRRHR) has adopted and implemented the AMDD guidelines on the registration of IVD medical devices and to provide the regulatory requirement and registration process.

ASEAN Agreement on Medical Device Directive (AMDD) in 2014, mandated the Philippines to implement the following provisions:

  1. a) “require the person responsible for placing the IVD medical devices in that Member State or the authorized representative to register the IVD medical devices with the regulatory authority by of that Member State”
  2. b) “shall undertake all necessary measures to ensure that only IVD medical devices which conform to the AMDD may be placed on markets of that Member State”
  3. c) “put in place an appropriate system for the registration of IVD medical devices with the Regulatory Authority of that Member State”.
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