Certificate of free sale
Certificate of free sale
For devices marketed in third countries, the buyer country often requires an official certificate stating that there are no obstacles for their export. Upon request, Fimea issues certificates of free sale for medical devices that have been notified to Fimea in the CERE register or to Eudamed. Provisions on the certificate of free sale are laid down in Article 60 of Regulation 2017/745 or Article 55 of Regulation 2017/746.
Where necessary, Fimea will issue registration certificates for medical devices notified to Fimea. Registration certificates are requested in accordance with the procedure instructed for a certificate of free sale.
Requests for certificates of free sale and registration certificates are to be sent to: email@example.com.
The certificates are subject to a charge, and the fee charged is determined in accordance with the Decree of the Ministry of Social Affairs and Health on fees chargeable by the Finnish Medicines Agency (section 5 of the Annex). Note! A special charge is applied to an express delivery of a certificate (delivery time less than 2 weeks of the order). The charge is invoiced in connection with the issuance of the certificate.
Instructions for requesting a certificate of free sale
The certificate of free sale can be requested by a domestic manufacturer and an authorised representative who have registered their devices with Fimea. The certificate of free sale is issued separately for devices in conformity with the Regulation and the Directive, as well as for the company’s different trade names and potential auxiliary trade names.
The same certificate of free sale may not contain:
- devices in conformity with the Regulation and the Directive;
- several different trade names or SRNs.
A request for a certificate of free sale shall be sent to Fimea by e-mail at: firstname.lastname@example.org.
If the information in the request is incorrect, the applicant may be required to supplement their request for a certificate of free sale. Fimea will send the signed and stamped certificate of free sale by post.
The certificate of free sale is issued in English.
Information to be provided in the request for a certificate of free sale
When applying for the certificate, the applicant must indicate:
- The country of export, if you want an export country certificate
- The number of certificates requested
- The copies requested at the same time are cheaper. The copy is equivalent to the original certificate. The copy will be furnished with an original signature and stamp.
- Delivery and billing address for the certificate
- For the manufacturer and potential authorised representative:
- contact details
- the SRN number, if such has been assigned to the operator
- required for a certificate in accordance with the Regulation
- For the devices requested to be included in the certificate:
- trade name
- Fimea’s reference number
- Basic UDI-DI and UDI-DI, if assigned for the device
- other details of the device that are requested to be included in the certificate
- NOTE! The information requested to be included in the certificate must be found from the register (Eudamed or Fimea's CERE register).
- Unique identification number of the certificate issued by the notified body (if a notified body was required for the conformity assessment)
In addition, the application must be accompanied by a declaration of conformity or a certificate issued by a notified body if a notified body was involved in the conformity assessment.