Philippines: Requirement of CMDR and CMDN start period amended from 1 April 2022 to 1 April 2023

Section V (1) of FC No. 2021-002-A is hereby amended as follows:

1. The date when all Class B, C, and D medical devices that are already in the Philippine market prior to the effectivity of FC No. 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 License to Operate the medical device establishment shall be provided at the point of entry and/or as part of bidding requirements.

2. The start period of requiring CMDN or at least with pending CMDN application for class B, C and D medical devices shall be amended from 1 April 2022 to 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.

Sources:

FDA Circular No.2021-002-A || 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”

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