BOC clarifies FDA clearance of foreign donations for the COVID-19 Public Health Emergency

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 depending on the health risk of their products prior to customs release.

Considering the COVID-19 outbreak, the FDA coordinated with the BOC that foreign donations of PPE (Face Masks including N95 Masks, Shoe Covers, Gloves, Head Covers, and Gowns) are exempted from securing an FDA clearance. Moreover, the FDA also mentioned that the companies, other than medical device establishments, who use facemasks in the performance of their jobs and are strictly for company use are allowed to make direct importation without any certification from the FDA.

As to PPEs intended to enter the local market for commercial purposes, the FDA clarified that importers of PPE for commercial purposes are exempt from presentation of a CPN/CPR prior customs release provided that they are able 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 PPE for donation and commercial purposes.

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PUBLIC INFORMATION OFFICE (PIO) Bureau of Customs G/F OCOM Building, South Harbor (Port of Manila), Manila Landline: (02) 8527-8259 or (02) 8527-1968 Fax: (02) 8527-1968