FDA Advisory No. 2020-420 || Procedure for FDA Clearance of Personal Protective Equipment (PPE) Prior Customs Release

Due to the rapid spread of COVID-19, the following measures are adopted for the expedient release of certain personal protective equipment (PPE) within the jurisdiction of the Bureau of Customs. The PPE includes:

  1. Face Masks including N95 masks
  2. Shoe Covers
  3. Gloves
  4. Head Covers, and
  5. Gowns

For the above-mentioned PPE intended for entry to the local market for commercial use, the presentation of a copy of the importer’s License to Operate (LTO) and proof of application for notification such as electronic acknowledgement should be sufficient compliance for customs release.

For foreign donations of the same PPE, clearance from FDA shall not be needed. These include companies, other than medical device establishments, with employees who use facemasks in the performance of their jobs and are strictly for company use.

Said procedure for clearance of PPE prior to customs release shall be in effect until otherwise lifted.

For your guidance.

Attachment:-> FDA Advisory No.2020-420

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