This Article deals with the New Medical Device Registration policy of the Philippines, Published by Food and Drug Administration on 27 September 2022. The latest Circular, provides guidelines on the abridged processing of medical device applications for registration with product approval issued by the National Regulatory Authority (NRA) of any ASEAN member country under the AMDD-CSDT requirements. This Circular applies to Class B, C and D medical devices that are to be imported, distributed and sold in the Philippines.
This Circular is designed to streamline the process of medical device registration and reduce the time required to bring innovative and life-saving medical devices to market. Abridged processing refers to the expedited evaluation process performed by the FDA through the Center for Device Regulation, Radiation Health and Research (CDRRHR), based on the reliance principle.
The Guidelines include:
- Expedition by the FDA in processing of applications for registration of medical devices approved by the NRA of any ASEAN member country.
- Only Class B, C, and D medical devices may be submitted for registration under the FDA’s accelerated process.
- Applicants must provide legislative and technical criteria in accordance with AO No. 2018-0002, including current and identical technical specifications to those provided to the reference NRA where CPR was granted.
- FDA retains the authority to omit any necessary processing in any of the following situations: unfavorable reports from other nations, divergent opinions from different ASEAN nations, and additional situations that require a thorough review of petitions for authorisation of medical devices.
- The labeling requirements will be assessed in accordance with AO No. 2018-0002 and the CDRRHR will receive evidence of payment first.
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Source – FDA-Circular
