Medical Device
Instructions
Manufacturers, authorized representatives, importers, sellers, and specialized stores of medical devices in the Faroe Islands must register with the Chief Pharmacist. Shops that retail medical devices are not subject to the registration requirement unless they also have another role besides being a seller. This is a legal requirement and can be punished with a fine or higher penalty if one does not comply with the law.
Here you will find an overview of all registered actors involved in medical devices in the Faroe Islands.
Citizens and relatives can report incidents related to medical devices. By registering these incidents, problems can be quickly limited, necessary corrections can be made as soon as possible, and similar incidents prevented. If a citizen or relative reports, they will be asked if it is okay for the Chief Pharmacist to contact them. Contact information will only be used by the Chief Pharmacist.
It is a legal requirement that importers, sellers, manufacturers, responsible hospital operators, authorized healthcare professionals, and others who use medical devices as part of their work must immediately report to the Chief Pharmacist any faults, defects, or weaknesses, including inaccuracies in labeling or usage instructions, that can worsen the health condition of a patient or user, or lead to death. Incidents that did not have serious consequences due to intervention by, for example, healthcare professionals, and incidents where there is doubt about whether the incident is reportable, must also be reported.