Today the Philippines FDA provided important guidance related to the new Medical Device Regulations at a public forum held in Manila. The target date for implementation of AO 2018-0002 was announced for April 11, 2019. At that time, Class A, B, C and D medical devices will require a Certificate of Medical Device Notification (CMDN) in order to be imported and placed on the market in the Philippines. The grace period for compliance will be announced in March and expected to be 12 months.
Certificates of Product Registration (CPR) issued under the old Rules will remain valid until expiry at which point a license renewal application will generate a fresh CMDN. Certificates of Exemption (COE) issued under the old Rules will remain valid until an announcement by the FDA. The timing of this announcement has not yet been determined but likely to be several months to 1 year in the future. IVD devices are not affected by the new Rules.
Government processing fee for the CMDN will be based on the old Rules (e.g., US$175 covering five years) at first and then transition to the new risk-based fee structure floated back in July of last year (ref. article available here).
Official processing times will remain at 180 working days due to the high anticipated application volumes, however actual review times should be much faster.
Once implementation is made official, FDA will no longer accept applications for CPR or COE. However, any CPR or COE applications submitted prior to the implementation date will processed as normal.
Implementation of the new Rules is being conducted in phases. These changes represent Phase 0 and Phase 1 of the implementation plan announced in January of last year (copy of document available here ). Timelines for Phase 2 and 3 in which Class B, C and D devices will require the more comprehensive Certificate of Medical Device Registration (CMDR) have not yet been announced.
Important questions remain about classification, grouping, the validity of the products under COE, the management of the new fees, etc. Clarifications on these points are expected in March.
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.