The Swiss Single Registration Number (CHRN) is assigned by Swissmedic based on the Medical Device Ordinance (MedDO; SR 812.213). It is assigned to Swiss manufacturers, authorised representatives or importers and serves to uniquely identify them.
Meditrial successfully represents many global life sciences companies as their Swiss Representative.
Until the MRA (Mutual Recognition Agreement) is updated, Swissmedic is unable to assign a European Single Registration Number (SRN) via EUDAMED for Swiss economic operators. In order to mitigate this loss of information and to further ensure market surveillance in Switzerland, manufacturers, authorised representatives and importers established in Switzerland must register once with Swissmedic.
Economic operators must register within three months of launching their first product on the Swiss market. The timeframe is intended to avoid delays in the launch of compliant products and to prevent supply bottlenecks in Switzerland. For subsequent product launches, no further registration is required.
Swissmedic has published an information sheet which describes in detail the process of applying for a CHRN. Visit the Swissmedic website for more details.
Using the industry’s best practices and high-end expertise, Meditrial’s specialized team offers Swiss Rep services and regulatory support for compliance with the Swiss Regulations and applicable requirements.
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