Abridged registration process for ASEAN registered medical devices in the Philippines
Abridged processing for applications of registration or notification of medical devices in the Philippines was introduced on 25 November 2021 as the Food and Drug Administration (FDA) issued Advisory No. 2021-3084.
The introduction of this advisory means that medical devices that have already been approved by the regulatory authority of another ASEAN member country will benefit from easier and faster registration processes compared to those without such approval. Product registration certificates of approval issued by other countries outside the ASEAN bloc do not qualify for this abridged process.
The abridged process only applies to applications for Certificate of Medical Device Notification (CMDN) or Certificate of Medical Device Registration (CMDR) of medical devices in classes B, C, and D. In order to qualify for the abridged process, the medical device approval obtained in another ASEAN member country must have been applied for using the Common Submission Dossier Template (CSDT). And a declaration must be made that the CSDT Technical Requirements submitted to the Philippines’ FDA are the same as those submitted to the counterpart regulatory agency who issued the Certificate of Product Registration.
The following ASEAN member countries currently require registration applications to be submitted using the CSDT:
Companies still need to submit all the legal and applicable technical requirements in accordance with Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on The ASEAN Harmonized Technical Requirements”.
The main aim of this advisory is to increase the efficiency of regulatory systems by implementing good regulatory reliance practices, which in turn will result in faster access to safe, quality, and effective medical devices intended to.
This expedited review process is already in effect as of 25 November 2021.
Click here for FDA Advisory no. 2021-3084 from the Philippines FDA.
To learn more about registering medical devices in the Philippines click here.
To learn more about the medical device market in the Philippines click here.
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