authorization for a medical device based on the asean harmonized technical requirements new guidance

Authorization For a Medical Device Based on the ASEAN Harmonized Technical Requirements: New Guidance

All Class B, C and D medical devices that are already in the Philippine market prior to the effectivity of FDA Circular 2021-002-A may continue to be manufactured, imported, exported, distributed, transferred, sold, or offered for sale without CMDN shall be extended until 31 March 2023.

The Food and Drug Administration (FDA) of The Philippines officially issued the amendment to FDA Circular No. 2021-002-A. It extends the date wherein all the non-registrable Class B, C and D medical devices not included in the list of registrable medical devices based on FC No 2020-001A may continue to be manufactured, imported, exported, distributed, transferred, sold, or offered for sale without a Certificate of Medical Device Notification (CMDN). It also aims to amend the start period for requiring CMND or at least with pending CMDN applications.

To ensure the availability of the medical devices during the transition period in applying for a CMDN, the Food and Drug Administration have amended the guidelines of Section V (1) of FDA Circular No. 2021-00A so the start period requiring CMDN or at least with pending CMDN applications for Class B, C and D medical devices shall be amended from 01 April 2022 to 01 April 2023.

All the other provisions of FDA Circular No 2021-002 and FDA Circular 2021-002A not affected by the issuance of this new circular shall remain in effect. 

For more information: 

Click here:  https://www.fda.gov.ph/fda-circular-no-2021-002-b-amendment-to-fda-circular-no-2021-002-a-entitled-addendum-to-fda-circular-no-2021-002-re-full-implementation-of-administrative-order-no-2018-0002-entitled/

If you have any questions regarding medical device registration and representation in the Philippines, please contact us at sales@andamanmed.com

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