PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS
Initial implementation of DOH Administrative Order 2018-002 (the new Medical Device Rules) was made official with the publication of FDA Circular 2020-0001 on January 23. The implementation plan has Class B, C and D Notified devices (as in listed in FDA Memo 2014-005) requiring a Certificate of Medical Device Registration (CMDR) by February 7, 2020. Likewise, all Class A device will require a Certificate of Medical Device Notification (CMDN) at implementation. Note that existing Certificates of Product Registration (CPR) issued under the old Rules will remain valid until their expiration date, and Certificates of Exemption (COE) will remain valid until November 3, 2021, or two years after issuance (whichever is shorter).
Other important aspects of the implementation plan include:
Notified medical devices will be re-classified according to AMDD risk classification
Validity of initial CMDN & CMDR will be 5 years
A single application for a medical device system, family or multiple manufacturing sites is allowed (manual submission only), but will generate multiple CMDR/N
Government processing fee for initial CMDN/CMDR application is PhP7,500 (about US$150); and PHP5,000 (US$100) for renewal applications (pricing is subject to future adjustments)
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.
Technical data requirements are as per ASEAN MDD Common Submission Dossier Template (CSDT)
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 from country of origin with Notarized Declaration Letter of Authenticity
Color picture of the device from all sides
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 regarding the new medical device regulations.