CH-SWISSMEDIC-REG
Registration of the economic operator with Swissmedic
Registration of the manufacturer, authorised representative or importer, and assignment of the Swiss CHRN number
- Category
- National requirements
- Market
- Switzerland
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
In practice
A declaratory formality, to be completed within three months of first placing on the market (MedDO Article 55): it is not a precondition and is not assessed like an authorisation. Swissmedic assigns a unique identification number, the CHRN. Device registration itself goes through swissdamed. A manufacturer without a Swiss seat must first have appointed a Swiss authorised representative (MedDO Article 51).
Official sources
https://www.fedlex.admin.ch/eli/cc/2020/552/frSee where this text lands in your roadmap
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