Economic operators are registered within the first module of swissdamed. It consists of two stages: firstly, registration of companies, and then registration of the actual economic operators.
Currently, economic operators are still registered using the CHRN application form (see below, BW630_11_001defi_FO Application CHRN). As soon as swissdamed goes live, operators will be registered via the application.
Economic operators must register within three months of placing a device on the Swiss market. This timeframe is intended to avoid delays in bringing compliant devices onto the market and to prevent supply bottlenecks in Switzerland.
Economic operators who, by the time swissdamed has become available, have already registered with Swissmedic and thus have a Swiss Single Registration Number (CHRN), will not have to register again.
Once an economic operator is registered, it does not have to do so again when placing further devices on the market.
CHRN (Swiss Single Registration Number)
Based on the Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219), Swissmedic (the Swiss Agency for Therapeutic Products) assigns the Swiss Single Registration Number (CHRN). The CHRN is a unique Swiss registration number that Swissmedic assigns upon request, once only, to the economic operators concerned. The CHRN is used to identify them unambiguously. The CHRN consists of the abbreviation “CHRN” followed by the abbreviation of the role for which the actor is registered, and finally by an eight-digit number (e.g. CHRN-MF-2345678), as explained in the table below.