Charmaine Roson - Philippines

“If the product is not listed in Annex A, then the intended use and ASEAN MDD classification rules will be used, and the CDRRHR will confirm or reclassify as needed during the 14 day pre-submission period.”

Charmaine Roson
Principal Consultant
Asia Actual Philippines

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Philippines Releases New Guidance on Class A Medical Devices

Published on: August 24th, 2021

FDA Releases List of 1,242 Medical Device Categories That Require a CMDN

To further help with clarifying the regulatory requirements for medical device manufacturers seeking market access in the Philippines, the FDA has released a list of Class A 1,242 product categories in Circular 2021-017 on August 16, 2021. Medical device manufacturers of Class A products specified in Annex A or under the ASEAN MDD, must obtain a Certificate of Medical Device Notification (CMDN). This must be done before manufacturing, distributing, importing, selling, and/or advertising the medical device. If the product is not listed in Annex A, then the intended use and ASEAN MDD classification rules will be used, and the CDRRHR will confirm or reclassify as needed during the 14 day pre-submission period. Classification of a medical device is subject to change if features of a product, such as intended use or duration of use, were to change.

This guidance will take effect fifteen (15) days after its publication in a newspaper of general circulation and when three (3) certified copies are filed to the UP Law Center.

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Philippines Releases New Guidance on Class A Medical Devices

the FDA has released a list of Class A 1,242 product categories in Circular 2021-017 on August 16, 2021. Medical device manufacturers of Class A products specified in Annex A or under the ASEAN MDD, must obtain a Certificate of Medical Device Notification (CMDN).