Remaining Class B, C, and D Products to Require Notifications
On January 4th, the Philippines FDA released FDA Circular 2021-002 outlining new requirements for previously exempted medical devices, amending the previous transition plan. All remaining Class B, C, and D devices not listed in the updated Annex will now need to apply under the Notification route currently used for Class A devices.
Previously, only Class A and a specific list of products found in Annex A of Circular 2014-005 required registration. The FDA also took this opportunity to amend the Annex A list with FDA Circular 2020-001-A and reclassified 31 medical devices. Notably, resuscitators (manually controlled and automatically controlled) and ventilators have been added to Annex A and will now require Registration. It is recommended that manufacturers currently marketing ventilators and automatic respirators in the Philippines under Certificates of Exemption (CoEs) submit a CMDR application as soon as possible. The full list can be found here.
Regulatory Process for Non-Listed Products
Devices not specifically listed are to be classified in accordance with the rules of the AMDD as stated in item 2, Section V of the General Guidelines of AO 2018-002.
Non-Listed Notifications will be valid for 2 years. Manufacturers will then need to submit a new CMDR application 3 months before expiration to maintain market access. Regarding Certificates of Exemption (COE), they will remain in effect until November 3rd, 2021 or 2 years after issuance, whichever happens first, and will then need a CMDN.
While the Notification process is straightforward and can be completed in about a month, technical documentation will still need to be submitted in accordance with the CSDT Template. Notifications also require items such as a device description, Certificate of Conformity, Declaration of Conformity, Declaration of Shelf Life and clear, complete, and colored pictures of the labeling. Notification fees will be PhP3,000 (~US$60) plus the standard 1% Legal Research Fee (LRF).
The Philippines FDA is also expected to release new IVD Regulations soon which will outline the implementation schedule. Notifications could begin as soon as January 2022.