The Philippines Food and Drug Administration (FDA) has issued FDA Circular No. 2021-002-B, an amended version of Circular No. 2021-002-A. This is an addendum to Circular No. 2021-002, which contains information on the issuance of medical device authorization. This latest circular was published in April 2022.
According to Circular No. 2021-002-A, medical devices under Class B, C and D could only be manufactured, imported, exported, distributed, transferred, sold, or offered for sale without a Certificate of Medical Device Notification (CMDN) until 31 March 2022.
However, according to the latest circular, this deadline has been extended until 31 March 2023. From 1 April 2023, the medical devices must have an approved CMDN or proof of an ongoing application for CMDN.
More details can be found in “FDA Circular No.2021-002-B: Amendment to FDA Circular No. 2021-002-A, April 2022”: https://www.fda.gov.ph/wp-content/uploads/2022/04/FDA-Circular-No.2021-002-B-1.pdf