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PHILIPPINES FDA CHANGES IMPLEMENTATION PLAN FOR NEW MEDICAL DEVICE REGULATIONS

The FDA hosted a meeting on September 19th in Manila at which a revised implementation strategy for the new medical device regulations (Administrative Order 2018-0002) was rolled out. Significant changes were made to the original implementation plan announced back on February 22 to simplify and streamline transition to the new Rules.

 
Under the new plan, Class B, C and D Notified devices (as in listed in FDA Memo 2014-005) will require a Certificate of Medical Device Registration (CMDR) by November 3, 2019.  Likewise, all Class A device will require a Certificate of Medical Device Notification (CMDN) at implementation. Note that Certificates of Product Registration (CPR) issued under the current Rules will remain valid until their expiration date, and Certificates of Exemption (COE) will remain valid until November 3, 2021.
  1. Notified medical devices will be re-classified according to AMDD risk classification
  2. Validity of initial CMDN & CMDR will be 5 years
  3. A single application for a medical device system, family or multiple manufacturing sites is allowed (manual submission only), but will generate multiple CMDR/N
  4. Government processing fee for initial CMDN/CMDR application is PhP7,500 (about US$150)
  5. All Medical Devices and IVD that are not included in the scope of initial implementation shall be considered non-regulated products; importers License to Operate (LTO) may be provided for customs clearance in lieu of a COE.
  6. Technical data requirements are as per ASEAN MDD Common Submission Dossier Template (CSDT)
  7. Administrative data requirements include:
    • Letter of authorization copy with Notarized Declaration Letter of Authenticity
    • ISO 13485 copy with Notarized Declaration Letter of Authenticity
    • Requirement for Certificate of Free Sales (CFS) has been eliminated
    • Copy of registration in country of origin with Notarized Declaration Letter of Authenticity
    • Color picture of the device from all sides

The FDA will release written guidelines to make these changes official.

Asia Actual has a strong regulatory team in Manila to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.