Registration and marketing

Updated 13 October 2015

Manufacturers, EU representatives, importers and distributors of medical devices and specialised stores are required to register with the Danish Medicines Agency. The registration helps us offer guidance to companies, monitor the market and process incidents, which contribute to promoting patient safety.

Registration

The following companies must register with the Danish Medicines Agency if they are headquartered in Denmark:

  • Manufacturers of medical devices in classes I, IIa, IIb and III, active implantable medical devices, custom-made devices as well as system and medical treatment packages. Companies sterilising and marketing CE marked devices that are marketed as non-sterilised by the manufacturer, but intended to be sterilised before use. The duty to register also applies to Danish representatives of manufacturers outside the EU.
  • Manufacturers of in vitro diagnostic devices (IVD)
  • Distributors and importers of medical devices
  • Specialised stores are shops specialising in the sale of medical devices in risk classes IIa, IIb and III, active implantable medical devices and in vitro diagnostic medical devices. To be considered a specialised store, a minimum of 50% of the store's sales must be constituted by the above-mentioned types of medical device. For example, the stores may specialise in the sale of hearing aids or contact lenses.

We will send an acknowledgement when we have completed the registration.

Fees

We charge a registration fee and an annual fee according to the applicable executive orders on fees

  • The registration fee amounts to DKK 1,149 for manufacturers of class I devices, custom-made devices, in vitro diagnostic devices (IVD) and system and procedure packs.
  • The registration fee amounts to DKK 1,137 for importers and distributors.

In addition, we charge annual fees. The fee charged to manufacturers varies depending on the number of employees registered in the Danish Central Business Register at 31 January in the relevant year. Distributors and importers pay an annual fee independently of the number of employees.

We do not charge a fee to manufacturers, who only market class IIa, IIb and III devices as well as active implantable devices, nor to specialised stores.

Marketing

Companies are only allowed to market medical devices if they comply with the requirements laid down in the executive orders on medical devices. Further, it is important to note the rules governing advertising and relationships when cooperating with healthcare professionals

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