CHREP.me Blog – CH-REP and CH-Importer

Since 1 July 2026, every medical device, IVD, system and procedure pack placed on the Swiss market must be registered in swissdamed, the Swiss medical device database run by Swissmedic. The transition period ends on 31 December 2026 . On that same day, Swissmedic issues its first registration fee invoices. The fee model is simple on paper. In practice, it raises questions: What exactly counts as one registration? Do you pay every year? Who receives the invoice if you are based outside Switzerland? This article answers those questions with worked examples. Key facts at a glance Topic Rule Registration mandatory since 1 July 2026 End of transition period 31 December 2026 No transition period Devices with a reportable serious incident, field safety corrective action (FSCA) or trend Fee basis Per UDI-DI (Basic UDI-DI and package UDI-DIs are free) Fee amount CHF 200 for the first UDI-DI per calendar year, CHF 20 for each further UDI-DI Annual cap CHF 10,000 per manufacturer (...

Since 1 October 2026, Swiss importers can link their registration to the medical devices and IVDs they place on the Swiss market in swissdamed. Swissmedic gives importers until 1 April 2027 to complete these links. Here is what a CH-Importer has to do now, and what manufacturers should prepare. Importers link, they do not register A CH-Importer does not register devices in swissdamed. Devices are registered by Swiss manufacturers or, for foreign manufacturers, by their Swiss Authorised Representative (CH-REP) . The importer then adds its own details to an already registered device by linking its CHRN (CHRN-IM-…) to the device's UDI-DI. The legal basis is Art. 53 para. 4 MedDO and Art. 46 para. 4 IvDO, each in conjunction with Art. 13 para. 4 of the EU MDR or IVDR. Linking is free of charge for importers. Key dates Date What applies 1 July 2026 Device registration in swissdamed is mandatory 1 October 2026 Linking function for importers is available 31 December 2026 End of ...

Product Registration in Switzerland Updated on 28 October 2026 to reflect the current Swissmedic requirements. Since 1 July 2026, medical devices, IVDs, systems and procedure packs placed on the Swiss market must be registered in swissdamed, the Swiss database for medical devices. This also applies to manufacturers based outside Switzerland: their Swiss Authorised Representative (CH-REP) registers the devices for them. Important deadlines 1 July 2026: device registration in swissdamed became mandatory. 31 December 2026: end of the transitional period. Devices placed on the market from 1 July 2026, and existing devices that are still being placed on the market, must be registered by this date at the latest. Vigilance cases: devices affected by a serious incident, a field safety corrective action or a trend report must be registered immediately, without a transitional period. Who registers devices? Swiss manufacturers Swiss persons who assemble systems and procedure packs Swiss...