Philippines Announces New Medical Device Regulations
The Philippines Department of Health has launched new medical device regulations as announced in Administrative Order 2018-0002 dated January 26, 2018. The effective date is expected to be April 1, 2018, fifteen days after publication in two newspapers of general circulation. Medical device manufacturers are advised to take appropriate action to maintain market access for their devices in the Philippines.
The new system will be implemented in phases. At first, all Class A device will be required to obtain a Certificate of Medical Device Notification (CMDN). The same requirement applies to new registration applications for notified devices (those that previously required a Certificate of Product Registration). Manufacturers or their local authorized agents should have a 12-month grace period to comply before losing market access. All current Certificates of Product Registration (CPR) will remain valid until their expiry date.
Then in Phase 1 implementation of the new requirements, all non-notified Class B, C and D devices will be required to obtain a CMDN. In Phase 2, Class D devices will be required to meet the stricter standards of a Certificate of Product Registration (CMDR). Finally, in Phase 3, all Class B and C devices will be required to obtain a CMDR. No information has yet been released on the timing of these phases.
Technical data requirements for the CMDR are similar to those of the CPR, but data must be formatted as per the ASEAN Common Submission Dossier Template (ACSDT). Another significant change will be to product grouping which is expected to be more generous under ASEAN MDD guidelines. Additionally, the CMDN and CMDR will be valid for 5 years.
Manufacturers are advised to determine the classification of all devices of interest for the Philippines market to confirm which phase will apply to each.
Further guidance is expected in the coming weeks and more information including a full copy of AO 2018-0002 is available on the Philippines page of the Asia Actual web site.
Please contact Asia Actual with questions or support requests from our team in Manila.