Free Sale Certificate Medical Device
The Free Sale Certificate (EU 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 Authorized Representative on behalf of a foreign medical device manufacturer.
For the issuance of FSC 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.
Read more about EU Registration (EUDAMED) Process >>>
Free Sale Certificate Europe
If the medical device is not manufactured in Europe, only the Authorized Representative is able to obtain the free sale certificate on behalf of the manufacturer.
The EU FSC 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 FSC
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.