Changes to CDRH Export Certification and Tracking System (CECATS)  

 

As of September 25, 2017, the FDA has updated the CDRH Export Certification and Tracking System (CECATS).  CECATS is the web-based system for requesting export documents and certificates for international trade which has been implemented to process applications and requests more efficiently than the mail-in system.

The latest upgrades to CECATS include:

• Updates to section 4 of a Certificate to Foreign Government (CFG) application that:
  • Require product listings to identify all manufacturers involved in the manufacturing process.
  • Remove listings with a role of only US Manufacturer of Export Only, Foreign Exporter, or Foreign Private Label Distributor from section 4.
  • Identify and prevent submission of an application with inactive devices.
  • Allow Save & Exit from section 4. Error messages will be displayed upon re-entry.
• The option for firms to add an alternate email address. Email notifications will be sent to both email addresses identified on the application.
• Requestor must indicate whether each establishment involved has been inspected by the FDA.
• Applications cannot be submitted with inactive establishments.
• Requestor has the ability to preview the certificate and confirm the product and firm information is correct.

To assist firms through the new changes, the FDA has updated the Exporting Medical Devices FAQs.  The new set of FAQ’s includes step-by-step instructions for logging into and navigating the system and provides tips about completing applications.

Using CECATS rather than mailing in paper applications can result in a reduced processing time for certificates and requests, savings on mailing costs, real-time validation of firm-specific data, in addition to allowing firms to receive status updates on their requests.  Although the FDA still accepts paper requests, as of October 1, 2016, any paper applications received are automatically converted to electronic applications on CECATS.

 

 

 

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