BOC says PPE donations exempt from FDA clearance requirement

Foreign donations of personal protective equipment (PPEs) do not need a clearance from the Food and Drug Administration (FDA), the Bureau of Customs (BOC) clarified Monday.

In a statement, the BOC said PPE donations are exempted from securing a Certificate of Product Notification (CPN) or Certificate of Product Registration (CPR).

"Considering the COVID-19 outbreak, the FDA coordinated with the BOC that foreign donations of PPEs (face masks including N95 masks, shoe covers, gloves, head covers, and gowns) are exempted from securing an FDA clearance," it said.

"Moreover, the FDA also mentioned that companies, other than medical device establishments, which use face masks in the performance of their jobs and are strictly for company use are allowed to make direct importation without any certification from the FDA," it added.

The BOC last week said it has been expediting the release of PPEs to the public, given the high demand for such products.

For PPEs to be used for commercial purposes, the BOC said the FDA has since clarified that importers are exempt from the presentation of a CPN or CPR.

It noted, however, that importers need to provide a copy of License to Operate (LTO) and proof of application for product notification with the FDA.

"The FDA and BOC assures that both agencies are prioritizing the expeditious facilitation of PPEs for donation and commercial purposes," said the BOC.

The country has since implemented an enhanced community quarantine in the entire Luzon from 12:00 a.m. on March 17 until April 12, restricting travel within the region in efforts to contain the spread of COVID-19.—AOL, GMA News