FDA launches new website for medtech export documents

November 30, 2012 by MassDevice staff

The FDA launches the Export Certification & Tracking System, allowing applicants to submit export document requests electronically.

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The FDA's Center for Devices & Radiological Health launched its Export Certification & Tracking System, a new website for submitting and processing export document requests electronically, an alternative to paper submissions.

The system could reduce the certificate processing time and allow the applicants to see real-time status updates online, but it is only currently available for certificates to foreign governments, which account for 95% of all export certificate requests, the FDA noted.

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The CDRH expects to advance the next phase of the website, including additional certificates of exportability, non-clinical research use only certificates, simple notifications of medical device exports and export permit letters, according to the note.

The FDA will offer online training sessions on CECATS from 2 to 3:30 p.m. on Monday, Dec. 3, 2012, Tuesday, Jan. 8, 2013, and Tuesday, Feb. 5, 2013. Participants don't have to pre-register for the sessions, according to the FDA note.