Distributors and importers of medical devices
An importer is a Danish company that places a medical device from another EU/EEA country or a third country for sale on the Danish market.
A distributor is a Danish company that makes a medical device available on the Danish market.
Danish distributors and importers of medical devices must register with the Danish Medicines Agency and provide information about the company's address, the class/type of the device and the product group.
The duty to register does not apply to:
- manufacturers and representatives (Danish EU representatives of manufacturers headquartered outside Europe) that also distribute and/or import medical devices
- shops that only sell medical devices by retail.
The duty to register appears from executive order no. 843 of 28 June 2013 (in Danish only) on importers and distributors of medical devices.
Register company (in Danish only, opens in a new window)
Log in by using your business NemID. You will receive an acknowledgement when we have processed the registration. It may take up to 14 days.
We charge a fee for the registration (DKK 1,147).
We charge an annual fee based on the number of employees registered by the Danish Central Business Register at 31 January in the relevant year and riskclasses.
The size of the fees are laid down in the applicable executive order on fees for importers and distributors of medical devices.
|Low risk (class I, IVD and by measure)||Annual fee|
|0-9 employees||DKK 1,384|
|10-19 employees||DKK 5,519|
|20-49 employees||DKK 13,787|
|Over 49 employees||DKK 34,461|
|High risk (class IIa, IIb, III and AIMD)||Annual fee|
|0-9 employees||DKK 18,203|
|10-19 employees||DKK 39,156|
|20-49 employees||DKK 81,062|
|Over 49 employees||DKK 185,830|
In addition to this an annual fee is charged to cover the implementation of EU legislation on medical devices - regardless of risk class and number of employees. This fee will no longer apply after 2022.