The Philippine Food and Drug Administration (FDA) is seeking feedback on draft guidance for its transition to new medical device rules.
In January, an FDA circular was issued relating to the implementation of an Administrative Order entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”. The circular detailed the processes for applying and issuing a Certificate of Medical Device Notification (CMDN), however it did not provide any information on a transition period for the implementation of the Administrative Order.
The guidelines state that all manufacturers, traders and distributors/importers/exporters of medical devices issued with a License to Operate (LTO) may continue to manufacture, import, export, distribute and sell their medical devices without a CMDN until 31 March 2022.
It is important to note that this guidance refers to specific Class B, C and D medical devices that are not included in the list of registrable medical devices. For manufacturers, traders and distributors of these devices, there is a deadline of 31 March 2023 to apply for a CMDN. All other registered Class B, C and D devices are required to start applying for a MDN from 01 April 2023.
In addition, all Certificates of Exemption (COE) for Class B, C and D devices issued from 25 February 2014 remain valid until 31 March 2022 to provide time for all stakeholders to obtain a CMDN.
The deadline for the submission of comments is 14 May 2021.
Click here to read the notice in full.