Charmaine Roson - Philippines

“This new Circular significantly affects the regulatory process, as all medical devices will now need a Registration or Notification.”

Charmaine Roson, Philippines Principal Consultant

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Philippines Announces New Regulatory Requirement for All Medical Devices

Published on: January 6th, 2021

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).

IVD Update

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.

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Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today to see how new FDA regulations may affect your business in the Philippines.

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