Free Sale Certificate for Medical Device
The European Free Sale Certificate (FSC) is the evidence that medical devices could be legally sold or distributed freely without restriction with the approval of the regulatory authority of that country.
European Free Sale Certificate can be issued by any European country The Competent Authority issues it upon request by an Authorized 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/EC Representative, this certificate can only be obtained via a European Authorized Representative. We can act as your European Authorized Representative for your company, if you are from any non-European countries. Please contact us for more details.
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 from Europe and the Process
If the medical device is not manufactured in Europe, only the Authorized Representative is able to obtain the FSC on behalf of the manufacturer.
The 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.
European 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)
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.