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Manila Bulletin devider Philippines devider Customs: Foreign PPE donations exempted from FDA clearance

Customs: Foreign PPE donations exempted from FDA clearance

Published Mar 23, 2020 12:00 am
By Ariel Fernandez The Bureau of Customs (BOC) clarified on Monday that foreign donations of personal protective equipment (PPEs) are exempted from securing a Food and Drug Administration (FDA) clearance. In a statement, the BOC said: "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." "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. As to PPEs intended to enter the local market for commercial purposes, the BOC said importers of PPEs for commercial purposes are exempted from presenting a certificate of prior notification (CPN) or certificate of product registration (CPR), provided that they are able to provide a copy of license to operate and proof of application for product notification with the FDA. The FDA and BOC assured the public that both agencies are prioritizing the expeditious facilitation of release of donated PPEs and those for commercial purposes.
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