Last June 23, PFDA conducted a symposium discussing key circular drafts together with important issues and relevant regulations of the implementation of FDA Circular No. 2021-002.
FDA Circular No. 2021-002 was implemented back in March 2021 and a draft addendum to this document was released after to address the transition period for this circular. During the symposium, PFDA presented draft provisions of the addendum. Key points are as follows:
The transition period for class B-D Non-registrable products:
a. Class B-D Non-registrable products can still be imported and sold until March 2022 by having a License to Operate (LTO).
b. Previously issued Certificate of Exemption (COE) of Non-registrable Class B-D are only valid until March 2022. After March 2022, these products can be imported and sold only by having a Certificate of Medical Device Notification (CMDN).
c. By April 2023, a Certificate of Medical Device Registration (CMDR) will be required for the importation and distribution
PFDA also discussed the comprehensive draft list of Class A medical devices and take into consideration the comments from stakeholders. PFDA emphasized that if a device outside this list will be classified as Class A according to AMDD Risk Classifications, the device will still be a Class A device. In addition, PFDA confirms that Class A devices with COE are valid until November 3, 2021.
PFDA will release the final version of these regulations in the coming months. The most efficient way to curb possible inconveniences brought by these changes is still to apply and have the approved authorizations of affected products during the transition period.
FDA Circular No. 2021-002
Draft- Addendum to FDA Circular No. 2021-002
Draft-FDA Circular List of Class A Medical Devices