CFS publishing support
IGC supports to issue CFS for CE certified customers of medical device.
CFS (Certificate of Free Sales) is also called a free trade certificate, and it is a document required for registration of the import license for the product in the importing country which proving that the product is freely sold in the exporting country.
IGC is cooperating with AeMi World e.K in Berlin, Germany, and AeMi World e.K is issuing CFS from the German Federal Ministry for Health and Welfare (RAGeSo).
1) Applying CFS to IGC
The following documents and information are required upon application.
- Signed Doc
- The latest version of the technical construction file (including clinical evaluation report
- Valid CE certificate
- CFS submission country.
2) DIMDI 등록
In order to receive CFS from the German Federal Ministry of Health and Welfare, the information system DIMDI registration must be preceded.
For more details, please refer to the registration page of the DIMDI menu.
3) CFS issuance application
AeMi World e.K visits directly to RAGeSo to apply for a CFS issue for that country..
RAGeSo reviews DIMDI information and the technical construction file submitted by the manufacturer to approve CFS issuance.
4) CFS confirmation
Applicants can check the CFS in a scanned copy issued by the IGC.
If you need more information after confirming CFS, you can request it back to the IGC.
Once verification is complete, you will be notarized.
5) Apostille Notarization
You directly visit the consulate where you are about to send CFS, you obtain Apostille through a notarial procedure. This procedure may be omitted by the request of the applicant.
After completing the above procedure, the manufacturer can see scanned image file, and then receive the original by international shipping.