The Swiss Single Registration Number (CHRN) is a unique identification number that Swissmedic assigns to Swiss manufacturers, authorised representatives and importers upon request. The CHRN is used to unambiguously identify a manufacturer, authorised representative or importer.
Until the MRA (Mutual Recognition Agreement) is updated, Swissmedic is unable to assign a European Single Registration Number (SRN) via EUDAMED for economic operators who are domiciled in Switzerland.
To mitigate the consequences of this loss of information and to continue to ensure market surveillance in Switzerland, it is necessary for manufacturers, authorised representatives and importers domiciled in Switzerland to register once with Swissmedic. After the successfull review of the information, Swissmedic will assign a Swiss Single Registration Number (CHRN) to the applicant.
Economic operators must register within three months of placing their first product on the Swiss market. This timeframe is intended to avoid delays in bringing compliant products onto the market and to prevent supply bottlenecks in Switzerland.
This rule also applies to persons who assemble systems and treatment units in accordance with Art. 11 MedDO. These persons are considered to be economic operators under Art. 47 para. 4 let. e TPA and must report to Swissmedic with their name and address within three months of placing systems or treatment units onto the market for the first time.
Once an economic operator has registered, it does not have to do so again when placing further products on the market.