Draft FDA Circular for comments amending FDA Circular 2021-002-A
The Philippines FDA issued an amendment to Circular no. 2021-002-A entitled “Addendum to FDA Circular No. Circular no. 2021-002 Re: Full implementation of administrative order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a medical device based on the ASEAN Harmonized Technical Requirements.
The Circular for comments amending FDA Circular 2021-002-A shall take effect immediately.
Last year, on 9 August 2021, the FDA had already issued Circular no. 2021-002-A entitled “Addendum to FDA Circular no. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN harmonized Technical Requirements.”
It was issued to provide guidelines for the transition period for the application of a CMDN for Class B, C, and D medical devices covered by FC No. 2021-002. It stated that these medical devices may continue to be manufactured, imported, exported, distributed, transferred, sold, or offered for sale without CMDN until 31 March 2022.
On 1 April 2022, these medical devices are required to have an approved CMDN or at least with an ongoing application for CMDN. But beyond these dates, the availability of these medical devices in the Philippines may be affected. In the interest of service and to ensure the availability of the medical devices during the transition period in applying for a CMDN, this Circular is hereby issued.
This issuance applies to Class B, C, and D medical devices that are not included in the list of registrable medical devices based on FC NO. 2020-001-A entitled “Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order No. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements.
The full draft of this regulation can be accessed at: https://www.fda.gov.ph/draft-for-comments-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/4
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