addendum to philippines fda circular 2021 0002 guidelines on applications for medical device authorizations

Philippines FDA requests comments on transition period for new medical device registration rules

The Philippines Food and Drug Administration (FDA) recently released a draft for comments on an Addendum to FDA Circular 2021-002: Full implementation of FDA Administrative Order No. 2018-00021.

FDA Circular 2021-0002 introduced the guidelines for the filing of applications and issuances of Certificates of Medical Device Notification (CMDN) and Certificates of Medical Device Registration (CMDR) for Class B, C and D medical devices which are considered non-registrable.

However, FDA Circular 2021-0002 did not specify any provisions for the period during which companies can continue to manufacture, distribute and offer for sale their medical device products without having already obtained a CMDN. This is in order to ensure continuous supply of medical devices in the Philippines during the transition period to full implementation of the guidelines on issuing authorizations for medical devices according to ASEAN harmonized technical requirements.  

Therefore, the FDA has drafted an Addendum to FDA Circular 2021-0002 to this effect and is currently requesting comments from medical device manufacturers, distributors, and authorized representatives. Comments should be sent by email to cdrrhr-prsdd@fda.gov.ph before 14 May 2021.

The draft for comments covers the guidelines for Class B, C, and D medical devices which are not included in the list of registrable medical devices in FDA Circular No 2020-001 as amended by FDA Circular No 2020-001A. The draft for comments proposes the following:

  • Manufacturers and distributors of medical devices with a previously issued License to Operate (LTO) will be allowed to manufacture, import, export, distribute, sell, or offer to sell their medical devices without CMDN until 31 March 2022. Furthermore, the LTO is to be provided at the entry point to facilitate importation and bidding requirements. After 1 April 2022, only those medical devices with CMDN or pending applications for CMDN shall be manufactured, imported, or distributed in the Philippines.
  • All FDA licensed manufacturers, distributors, importers and exporters of Class B, C, and D medical devices shall be given until 31 March 2023 to apply for CMDN.
  • Receiving of application for CMDN for Class B, C, and D medical devices shall cease starting 1 April 2023
  • All manufacturers, distributors, importers and exporters of Class B, C and D medical devices are required to apply for CMDR starting 1 April 2023. This provision does not apply to medical devices with valid CMDN within the scope of this issuance.
  • All Certificate of Exemption (COE) for Class B, C, and D medical devices issued from 25 February 2014 shall remain valid 31 until March 2022.

To read the full draft for comments in click here. 

Implications for medical device manufacturers and distributors

Medical device manufacturers and distributors should commence applications to obtain CMDNs as soon as possible to ensure continued supply of their products as of 1 April 2022. At present it takes between 1 to 2 months to obtain a CMDN if the medical device authorization application fulfils the application criteria. More information about the medical device registration process, timeline and fees in the Philippines can be found here. 

If you would like to know how we can help you maintain distribution of your medical device in the Philippines or how to register, please contact us at sales@andamanmed.com

Notes:

  1. FDA Administrative Order No. 2018-0002: “Guidelines Governing the Issuance of an Authorization a Medical Device based on the ASEAN Harmonized Technical Requirements”.

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