The Norwegian Medicines Agency may upon request issue time-limited Free Sales Certificates to Norwegian manufacturers/authorised representatives within the product areas covered by Act of 12 January 1995 no 6 on medical devices and the Regulation of 15 December 2005 no 1690 on medical devices. The manufacturer is asked to contact the agency on firstname.lastname@example.org, and we will forward a template for completion of information.
1st time registration
The Norwegian Directorate of Health request the following information (in the template) and attachments from the manufacturer:
- Correct name and adress for the Free sales Certificate.
- Number of Free Sales Certificates required (max 10).
- Documentation on registration in the Medical Device Database (Utstyrsdatabasen) on relevant devices. A copy of "Reports" should be attached.
- The information added in the template should be identical to that recorded in the Medical Device Database.
- Conformity assessment should be in accordance with Directive 90/385 / EEC on active implantable Medical devices, Directive 93/42 / EEC on Medical devices and Directive 98/79 / EC on In vitro diagnostic Medical devices.
- A copy of the certificate from the Notified body on the following categories of medical devices shall be attached:
- active implantable medical devices
- medical devices class I with measuring function
- medical devices class I marketed as sterile
- medical devices class II a, II b and III
- In vitro diagnostic (IVD) medical device covered by directive 98/79/EC, Annex II
- IVD products for self-testing
The documentation must cover all of the medical devices the Free Sales Certificate should apply to. It must be a consistence between name of device/ part number in the documentation and the 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.
- Previously issued certificates may be renewed provided there is absolutely no changes related to manufacturer, product or documentation. Please attach copies of existing Free Sales certificate and the number of copies required.
- Any amendments of name, description of product, address or name of manufacturer or of CE certificate require documentation as with first time registration.