Registration of medical device distributors

According to the Medical Devices Act No. 132/2020, distributors of medical devices are required to register with the Icelandic Medicines Agency.

The Agency registers distributors as entities subject to surveillance and sends them an invoice for the registration according to the agency's fee schedule. A distributor can begin distributing medical devices as soon as the registration is submitted.

Note that, despite maintaining a register of distributors of medical devices, the Icelandic Medicines Agency does not maintain a register of medical devices.

Who can apply?

Distributors of medical devices

Application processing

Immediate. The distribution of medical devices can begin as soon as the form is submitted

Cost

The cost is according to the fee schedule of the Icelandic Medicines Agency

If you are unable to use the web form

Please submit an iquiry to register as a distributor, or to update your registration to lyfjastofnun@lyfjastofnun.is. The following information must be provided:

• Name of distributor

• Distributor's ID number (if available)

• Distributor's address and post number

• Distributor's contact person for this registration

• The contact person's e-mail address

• Distributor's Telephone number

• List of brand names that the distributor intends to make available on the market

  • include the relevant contact person for each brand name