PFDA Extended CMDN Requirements of Class B-D Devices
PFDA released an updated circular “FDA Circular 2021-002-B” to extend the transition period of CMDN requirements for class B-D devices previously considered non-registrable from March 2022 to March 2023. This regulation states that affected devices can be imported and marketed freely without any CMDN during the period. Starting from April 2023, CMDN will be strictly required for importation and selling purposes.
The following diagram shows the applicable regulation to different general medical device risk class:
PFDA Released Two (2) Regulation Drafts for Public Comments
A.) Implementation of Abridged Route for Class B-D Devices with Prior ASEAN Authorization
PFDA released FDA Advisory No. 2021-3084 to open the abridged route for Class B-D products with registration or notification in any ASEAN National Regulatory Agency (NRA) before application for a certificate in the Philippines. To formally highlight key steps on the said advisory, the draft laid out the guidelines, procedure, and requirements for an application to undergo abridged review route. The important points of the draft regulation are summarized as follows:
- The product must be the same medical device as the approved by the ASEAN NRA. The brand/model/manufacturer and/or technical documentations /specifications of the device must be consistent with the approval from the other ASEAN NRA.
The applicant must submit an attestation on top of the legal and technical requirements stipulated in A.O. 2018-0002 that contains the following:
- 1. The CSDT technical documentation submitted in the Philippines and ASEAN counterpart are the same.
- 2. Understanding that the PFDA may suspend the applicant's License to Operate or the certificate, recall the product from the market, and be protected against third-party allegations of unlawful alteration
- The abridged evaluation will proceed according to the following steps:
B. Emerging New In Vitro Diagnostic Medical Devices Used for Detection and Diagnosis of SARS-CoV-2 Infection
This draft provides a special route for medical devices used for the diagnosis, screening, confirmation, monitoring /surveillance of the COVID-19 or SARS-CoV-2 infection using new emerging technologies. PFDA clarified in a virtual hearing that this only involves test kits and other related supplies. As of now, equipment products are not covered in this draft regulation.
The special certification requirements follow the initial requirements of the now established methods of COVID-19 detection such as RT-PCR, antigen, and antibody test kits. The main difference is these modern technologies do not have to be evaluated by RITM, PFDA’s reference laboratory for COVID-19 test kits with established technology.
- FDA Circular No. 2021-002-B: Extension of CMDN for Class B-D
- Draft for comment: Abridged Processing of Applications with prior ASEAN approval
- Draft for Comment: Emerging New In Vitro Diagnostic Medical Devices Used for Detection and Diagnosis of SARS-CoV-2 Infection