According to the Icelandic law on medical devices, distributors of medical devices who are responsible for the marketing of such devices in Iceland must register with The Icelandic Medicines Agency, IMA. The registration is subject to applicable fees.
To register as a distributor, or to update your registration, please submit an inquiry via Contact Us. 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
o Please include the relevant contact person for each brand name
Registration of medical devices
The IMA does not maintain registration of medical devices. Medical devices should be registered via EUDAMED.
Registration of other economic operators
Manufacturers of medical devices, importers and authorized representatives must, according to the regulation on medical devices, register in EUDAMED.
Operators are encouraged to contact their national competent authority on how to register in EUDAMED.