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Circulars Circular No. 2021-002-C

Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices Based on FDA Circular 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"

Food and Drug Administration

Issued 2023-03-29 Filed 2023-04-13 ONAR 23-0392