The Philippines FDA has been continuously supporting and adopting global policies to establish a better and efficient government services in regulating medical device products.
Among these policies are “Good Reliance Practices (GReIP)” of the World Health Organization (WHO) and the “ASEAN Medical Device Directive (AMDD)” that lay out the harmonized technical requirements and allows 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 application 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 ASEASN member country.
The following are the summarized key-point guidelines of the circular:
i. The abridged processing of application 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 device.
ii. The application should still be in compliance 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. Furthermore, all documents will be still subjected to pre-assessment by PFDA.
iii. The legal requirements will undergo a complete evaluation while among the technical files, the labelling requirements will be the focus of evaluation based on the AO No.2018-0002.
iv. The turnaround time for the abridged process will be thirty (30) working days starting from acknowledgement of receipt of proof of payment.
Abridged Process for Registration of ASEAN Approved Medical Devices