Distributors and importers of medical devices

23 July 2015, Updated 08 September 2015

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.

Form

Register company (in Danish only, opens in a new window)

Note: You have 20 minutes to complete and submit the form after you have opened it. If you spend more time, we will not receive your form.

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.

Fees

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.

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