Philippines FDA Class A Medical Device List Consultation

Philippines FDA Class A Medical Device List Consultation

The Philippines FDA has announced a virtual consultation on the draft Reference List of Class A Medical Devices and the draft addendum to the 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 PFDA has invited representatives from the medical device industry to attend the Virtual Public Hearing on Wednesday 23 June 2021.

Philippines FDA Circular No. 2021-002 was issued on Monday 4 January 2021 and contains the implementation schedule of Administrative Order No. 2018-0002 as well as guidelines to medical device manufacturers on how to apply for marketing authorization licenses. Read our article from 11 February 2021 to learn more about FDA Circular 2021-002.

This industry consultation concerns the Reference List of Class A Medical Devices only and is the next step in the consultation process following the release of a draft for comments on the List of Class A Medical Devices by the Philippines FDA at the end of April. Read our article from 29 April 2021 to learn more about the proposals.

The List of Class A Medical Devices helps medical device industry stakeholders to determine the appropriate risk classification of their device in order to apply for the correct market authorization; in this instance to apply for a Certificate of Medical Device Notification (CMDN).

CMDN is the required marketing authorization certificate for all medical device products that are classified as Class A products. In other words, if a medical device is on the List of Class A Medical Devices, then a CMDN should be applied for.  

Registration is now closed:

Registration was limited to 80 places which are now already filled. However, our clients may send in any issues they wish highlighted at the virtual consultation as we will be in attendance. To do so please send an email to contact@andamanmed.com entitled Philippines FDA Class A Consultation listing your concerns along with the following information:

  • Your name and job title
  • Company’s name
  • Email address
  • Name of the Class A product that is currently registered in the Philippines or that you wish to register in the future.

To learn more about registering medical devices in the Philippines click here.

We can register and import your medical device into the Philippines. Contact our sales team to find out more at sales@andamanmed.com

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