The Philippines FDA has been continuously supporting and adopting global policies to establish better and more efficient government services in regulating medical device products.
Among these policies are the "Good Reliance Practices (GRelP)" of the World Health Organization (WHO) and the "ASEAN Medical Device Directive (AMDD)" that lay out the harmonized technical requirements and allow national regulatory authorities (NRA) to promote safe, effective, and quality-assured medical device products.
The recently issued FDA Circular No. 2022-008 aims to provide guidelines on the abridged processing of applications for registration of medical devices that are covered under the Administrative Order (AO) No 2018-0002 with product approval issued by the NRA of any ASEAN member country.
Key-Point Guidelines of the Circular:
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The condensed processing of applications for registration will only be applicable to Class B, C, and D medical devices. Moreover, this circular does not cover in vitro diagnostic and refurbished medical devices.
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The application should still comply with AO No. 2018-0002, with complete submission of legal and technical requirements. In addition to the requirements, an attestation mentioning that the CSDT technical documentation submitted is the latest filed or approved by the reference NRA is required. Furthermore, all documents will still be subject to pre-assessment by PFDA.
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The legal requirements will undergo a complete evaluation, while among the technical files, the labeling requirements will be the focus of evaluation based on AO No. 2018-0002.
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The turnaround time for the abridged process will be thirty (30) working days starting from acknowledgment of receipt of proof of payment.