Market access

Market access for medical devices

Manufacturers, authorized representatives, importers, distributors or heath institutions may only place medical devices on the market, make them available on the market or put them into service when the applicable conformity assessment procedure has been successfully completed. This legal requirement also applies to medical devices that are given away free of charge, rented or used directly on patients. Certain medical devices are associated with a duty to notify the Swiss Agency for Therapeutic Products. Such notifications according to art. 18, 19, 53, 54, 103 and 108 MedDO of 1 July 2020 (Medical Devices Ordinance, SR 812.213) will attract a fee of CHF 300.- per notification according to the Ordinance of the Swiss Agency for Therapeutic Products on its fees (GebV-Swissmedic, SR 812.214.5).