FDAC 2020-001A: Updated List of Medical Devices for Registration

PFDA released FDA Circular No. 2020-001A in January 2021. This circular is an amendment to the Annex A of previously released FDA Circular No. 2020-001. This circular clarified vague classification of 31 items of the 137 medical devices listed in the previous version. In addition, FDAC 2020-001A added two medical devices required for registration- ventilator and resuscitator.

Ventilators fall under class C while for resuscitators fall under class A if manually controlled while class B if automatic controlled. The rest of the medical device in the FDA Circular No. 2020-001 remain unaffected by this circular.  This will serve as the basis for the classification and type of certificate that needs to be applied for (CMDN or CMDR).

As of now, this circular is yet to be implemented. The new circular will be implemented 15 days after publication in a newspaper of national circulation or after the receipt of the Office of the National Administrative Registrar (ONAR).

FDAC 2021-002: Notification of Non-registrable Class B-D Devices

PFDA announced the implementation of the three (3) phases for medical device registration according to AO 2018-0002 via the new circular which is FDAC 2021-002.

In this new circular, PFDA commenced the notification of class B-D devices that were previously considered non-registrable. Non-registrable medical devices are not listed in the Annex A of FDA Circular No. 2020-001 or its subsequent amendments. Upon implementation of FDAC 2021-002, such devices will now require a CMDN prior to importation and marketing.

Other important guidelines of the regulation are as follows:

  1. 1. Device classification: Risk Classification for Non-registrable devices not included in Annex A of FDAC 2020-001 and its amendments will be based on AMDD
  2. 2. Application Requirements and Method: Class B-D CMDN will follow the same application requirements and procedure as class A CMDN. PFDA is set to enhance the current online platform capability to accommodate class B-D device CMDN applications. Currently, it is limited to processing only CMDN application of class A devices. PFDA will accept applications after official implementation of this circular.
  3. 3. CMDN Validity: The CMDN validity of class B-D devices is only two years. Three months prior to its expiry the license holder must apply for a CMDR with the current requirements listed in Annex C/D/E of AO 2018-0002.
  4. 4. PFDA Fees: The application fee for CMDN of Class B-D is P 3,030 inclusive of the legal research fee. For CMDR, the fee will be in accordance with the existing fees during the time  of the application.

This circular is also yet to be implemented, 15 days after publication in a newspaper of national circulation or after the receipt of Office of the National Administrative Register (ONAR).

FDA Circular No. 2020-001A

FDA Circular No. 2021-002