Free Sales Certificate
The Norwegian Medicines Agency may upon request issue time-limited Free Sales Certificates to Norwegian manufacturers/authorised representatives.
How to apply for a Certificate of Free Sales
Download and fill out the appropriate template:
- Certificate of Free Sales template lagecy devices (Word, 31 KB)
- Certificate of Free Sales template MDR and IVDR (Word, 29 KB)
The Norwegian Medicines Agency requests the following information and attachments from the manufacturer/authorized representative:
- A filled out version of the correct certificate template
- Declaration of Conformity
- A copy of "Utstyrsrapport" from Utstyrsregisteret, as a confirmation that the devices are registered in our national database
A copy of the certificate issued by a notified body must be sent in when applying for a Certificate of Free Sales for devices that require the involvement of a notified body before being placed on the market.
You may request up to 10 copies of the certificate.
The documentation must cover all of the medical devices that appear on the Free Sales Certificate.
The completed template with correct information, including documentation attached and request for issuance of the Free Sales Certificate shall be sent to email@example.com.
Normally a certificate is issued within one month.