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Apply and Pay for European Authorized Representative for Medical Device to jump start with FSC process
Free Sale Certificate For Medical Devices
The EU Free Sale Certificate (FSC) is the evidence that medical device could be legally sold or distributed freely without restriction with the approval of the regulatory authority of that country. Free Sale Certificate can be issued by any European country. The Competent Authority issues it upon request by an EU Representative on behalf of a foreign medical device manufacturer.
If the foreign manufacturer is not within the EU and cannot communicate with the Competent Authority in the absence of EU Representative, this certificate can only be obtained via a European Authorized Representative. We can act as your EU Representative for your company, if you are from any non-European countries.
For the issuance of Free sale certificate by a European Authority, following documentation are required:
- EU Registration Details
- CE Certificate(s)
- EU Declaration of Conformity, duly signed, dated and stamped
- EU Representative designation letter.
The Chamber of Commerce, The Ministry of Foreign Affairs and the relevant Embassy are the three institutions in the EU Countries that can legalize the FSC.
EU Free Sale Certificate Europe
If the medical device is not manufactured in Europe, only the EU Authorized Representative is able to obtain the free sale certificate on behalf of the manufacturer.
The Free Sale Certificate process is as follows:
- Prepare Technical File
- Apply for NB CE Certification Or Prepare DOC for Class I devices
- Appoint European Authorized Representative
- EU Registration of the Medical Devices
- Apply FSC with medical device authority wherein EAR is located.
Free Sale Certificate Issue Timeline
If you are located outside EU territory and comply with EU Regulations for medical devices, you are eligible to apply.
- EAR Agreement Drafting and Mutual Signing : 1 week
- EU Registration : 1 Week
- FSC Application with Competent authority : 2-3 weeks.
- Issue of FSC and attestation : 1 week.
- Embassy attestation ( If required) : 2-3 weeks. (depends on country)
Our Fee For Free Sale Certification
We provide fast and economic services for non-European medical device manufacturers and exporters.
- EU Device Registration : 500 Euros / Device.
- FSC Application and Follow up : 4500 Euros up to 2 devices
- FSC Attestation : 350 Euros Per UMDNS Code
- Embassy attestation : Please contact us.
The European Free Sale Certificate (FSC) is proof that medical equipment can be lawfully sold or distributed freely and without limitation with the consent of the country’s regulatory authorities.
