This Circular issued on 9 August 2021 aims to provide guidelines for the transition period of medical devices covered by FC No. 2021-002 may apply for Certificate of Medical Device Notification (CMDN) for the manufacture, import, export, distribute, transfer, sell or offer for sale of the medical device products pending the issuance of the CMDN.
FDA Circular (FC) No. 2021-002 was issued in January 2021 for the full implementation of Administrative Order (AO) No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”. However, FC No. 2021-002 does not specify provisions for the period wherein the companies may be allowed to manufacture, import, export, distribute, transfer, sell and/or offer for sale their medical device products covered under the said issuance without the CMDN.
To provide guidelines on the transition period for the full implementation of AO 2018-002 and to ensure the continuous supply of the above medical devices in the local market, this Circular is hereby issued for implementation and compliance of all concerned.
- All Class B, C and D medical devices that are already in the Philippine market prior to the effectivity of this issuance may continue to be manufactured, imported, exported, distributed, transferred, sold or offered for sale without CMDN until 31 March 2022. However, starting 1 April 2022, only Class B, C and D medical devices with issued CMDN or with pending application for CMDN shall be allowed to be exported from the Philippines or manufactured, imported, distributed, transferred, sold or offered for sale in the country.
- In line with the full implementation AO 2018-0002, application for CMDN for Class B, C and D medical devices shall be accepted until 31 March 2023 only. Receiving of application for CMDN for Class B, C and D medical devices shall cease starting 1 April 2023.
- All manufacturers, traders, exporters, importers, and distributors of Class B, C and D medical devices shall secure a CMDR starting 1 April 2023.
- For Class B, C and D medical devices with CMDN validity after 1 April 2023, the CMDN shall remain valid until its expiry. However, three (3) months prior to the expiration of the CMDN, the company shall apply for a CMDR for the product. While the CMDR is on process, the MAH may continue to manufacture, import, export, distribute and/or sell the product.
- Marketing authorization holder of Class B, C and D medical devices that are non-registrable but were issued with a registration certificate prior to the implementation of FDA Circular No. 2020-001 as amended by FDA Circular No. 2020-001-A shall continue to apply for renewal of the registration certificate. Initial application for similar products shall comply with the CMDN requirements in accordance with the provisions of FDA Circular No. 2021-002 and this Circular.
- All Certificate of Exemption (COE) for Class B, C and D medical devices that were issued from 25 February 2014 shall remain valid until 31 March 2022. This is to provide ample time for the industry to apply for CMDN for the said medical devices.