Registration and marketing

Updated 01 January 2019



 

The online registration form is currently down.

To register, please write to mu-fab@dkma.dk and ask for a registration form for a manufacturer, importer or distributor, respectively.

 


 

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 two annual fees according to the applicable executive orders on fees

  • The registration fee amounts to DKK 1,159 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 1,147 for importers and distributors.

In addition, we charge two annual fees for both manucaturers and importers/distributors. The fee charged varies depending on risk class of a device and the number of employees registered in the Danish Central Business Register at 31 January in the relevant year.

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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