Foreign donations of PPE exempted from FDA clearance

    Thousands of aid packages donated by the People's Republic of China are unloaded at the Villamor Air Base in Pasay City on March 21, 2020. The donation includes assorted medical supplies, personal protective equipment, and testing kits for coronavirus. (by Toto Lozano / Presidential photo)

    THE Bureau of Customs and the Food and Drug Administration have exempted foreign donations of personal protective equipment (PPE) from securing an FDA clearance, taking into consideration the coronavirus disease 2019 (COVID-19) pandemic.

    The BOC said in a statement on Monday that as a general rule, importers of all products are required to obtain marketing authorization from the FDA in the form of either a certificate of product notification (CPN) or certificate of product registration (CPR), depending on the health risk of their products prior to customs release.

    The FDA has coordinated with the BOC on the exemption of foreign donations of face masks including N95 masks, shoe covers, gloves, head covers, and gowns.

    Customs said the FDA also stated that companies, other than medical device establishments, that 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.

    As to PPE intended to enter the local market for commercial purposes, the FDA said importers of PPE for commercial purposes are exempt from presentation of a CPN/CPR prior to customs release provided that they are able to provide a copy of license to operate and proof of application for product notification with the FDA.

    The BOC also said despite the limited workforce due to the Luzon-wide lockdown, its  has processed the release of 459 shipments of PPE, medical supplies, and donations from March 9 to 21.

    The Philippine Embassy in Singapore said Singapore’s donation of 3,000 testing kits is set to arrive in Manila on Tuesday.

    The embassy said Ambassador Joseph del Mar Yap has signed on behalf of Health Secretary Francisco Duque III the deed of donation for the testing kits and a  polymerase chain reaction machine.

    Earlier, China donated 100,000 testing kits as well as 100,000 surgical masks, 10,000 N95 masks and 10,000 PPE. — With Ashzel Hachero


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