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