Updated Guidelines on PPEs, Respirators, and Ventilators

Certificate of Medical Device Notification (CMDN) is now required to process the customs release of PPEs in addition to the LTO of the importer. For the customs release of ventilators and respirators, however, LTO remains the only requirement until 03 May 2021. After this period CPR will be required for these items and their accessories. These were the major updates through FDA Circular No. 2020-031 released last 03 November 2020.

Temporary Guidelines for the Release of Authorizations

PFDA now permits applicants to arrange private couriers to pick-up FDA authorizations. After PFDA canceled face-to-face transactions last August, authorizations, previously, can only be obtained via registered mail. They, however, maintained the sending of an advanced scanned copy of the authorization to the e-mail address indicated in the application.

 In addition, PFDA will now send a link with a reference number to the indicated e-mail address of the applicant to be able to track the delivery of the authorization sent via registered mail. Specific guidelines on the alternate mode of release of authorization have yet to be released.



FDA Circular No. 2020-031

FDA Advisory No. 2020-1953