Home » Breaking News, Customs & Trade, Ports/Terminals, Press Releases » BOC, FDA ease PPE import requirements

The Bureau of Customs (BOC) said foreign donations of personal protective equipment (PPE) such as face masks, shoe covers, gloves, head covers and gowns are exempt from having to secure Food and Drug Administration (FDA) clearance.

According to FDA, BOC said other medical device establishments that use face masks in the performance of their duties and are strictly for company use are allowed to make direct importation without any certification from the FDA.

As a general rule, importers of all products are required to obtain appropriate marketing authorization from the FDA in the form of either a Certificate of Product Notification or Certificate of Product Registration (CPN/CPR), depending on the health risk of their products prior to customs release.

But BOC said the exemptions are being made in consideration of efforts to stop the coronavirus disease (COVID-19) outbreak in the Philippines.

Importations of PPEs for commercial purposes will be exempt from presentation of a CPN/CPR prior to customs release provided importers are able to provide a copy of the License to Operate and proof of application for product notification with the FDA.

BOC and FDA have assured that both agencies are prioritizing the expeditious facilitation of PPEs for donation and commercial purposes, the customs bureau said.

Aside from this, BOC earlier said it is already allowing provisional goods declaration for imported donations.

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