Finnish Medicines Agency Fimea issues Free Sales Certificates for medical devices to manufacturers which export devices to the third countries.
The conditions of issuing Free Sales Certificates for medical devices among others are:
* manufacturer’s domicile is in Finland
* medical devices are registered in the product register maintained by Fimea.
According to Article 1 of Directive 93/42/EEC concerning medical devices manufacturer means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.