PR
The Food and Drug Administration (FDA) reiterated the guidelines under FDA Circular No. 2017-013 wherein importers of all products are required to obtain appropriate 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.
In these challenging times, the FDA has been receiving large number of applications for issuance of CPN and CPR of medical devices, including Personal Protective Equipment (PPE), which are vital for responding to the current pandemic situation.
The Personal Protective Equipment which requires FDA clearance are (1) Face Masks including N95 Masks, (2) Shoe Covers, (3) Gloves, (4) Head Covers, and (5) Gowns. Other products not listed in the foregoing do not require said FDA clearance. Individuals who have pending applications for CPN or CPR of PPE, the presentation of a copy of importer’s License To Operate (LTO) and proof of application such as electronic acknowledgement of its application for CPN or CPR with the FDA shall be sufficient compliance with the required clearance from the FDA for customs release.
The FDA also mentioned that the companies, other than medical device establishments, with employees 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.
The FDA and BOC assures that both agencies are prioritizing the issuance of the required certification of imported medical devices and the facilitation of its release, respectively.
