FDA certificates for certain medical equipment

Issued on 27 Apr 20

Due to the Covid-19 global outbreak and some of our members/clients may purchase a disposal medical/surgical mask for self-use or merchandise on behalf of a client and take care of the global logistic work. Some guys asked if the mask has a US FDA certificate is it guaranteed? Did you know that the U.S. Food and Drug Administration is issuing FDA certificates for certain medical equipment agencies "masks"? FDA will not issue registration certificates to medical device institutions, which means that those with FDA certification may be fake. You may have seen the FDA certificate (with the FDA logo or an eagle) However, the FDA announcement: "FDA does not issue Registration Certificates to medical device establishments. FDA does not certify registration and listing information for firms that have registered and listed. Registration and Listing does not denote approval or clearance of a firm or their devices" (PGA China member get ready to assist for merchandising and global delivery, please email comm.mgr@pacificglobal.com; jackylok@pacificglobal.com if any request) Medical equipment institutions can register with FDA. After obtaining the registration number, FDA will only give the applicant a reply letter (not a certificate) signed by the FDA Chief Executive Officer. It only proves that the manufacturer has completed the "production facility registration and product type registration" of the US FDA. Requirements and have obtained the FDA registration number. Device Registration and Listing: https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

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