The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is launching an electronic submission system through which manufacturers may request export certificates for their products.
Companies seeking export certificates in order to ship their devices to foreign markets must currently request export certificates via standard mail; this process will remain in place alongside the CRDH’s new electronic submission system.
The CDRH plans a two-phase implementation of the new system. First, the agency will make available a Web-based application, the CDRH Certification Application and Tracking System (CECATS), to medical device firms needing export certification. Companies interested in the electronic submission option must have a FDA Unified Registration and Listing System (FURLS) account in order to access CECATS.
Phase II will entail adding other certifications to the CDRH’s electronic system, including non-clinical research use only certificates, simple notifications and export permit letters.
By introducing an automated electronic submission option, the CDRH contends that processing time for export certificates will decrease; validations of requests will be done in real time; and medical device companies will be able to receive real-time updates online regarding the status of their submissions.
Ultimately, CECATS would also benefit medical device manufacturers by speeding up their ability to obtain necessary certification to satisfy foreign market regulators and commercialize their products faster.