In Switzerland, the revised Ordinance on Medical Devices (ODim) came into force on May 26, 2021, and the new Ordinance on In Vitro Diagnostic Medical Devices (ODiv) came into force on May 26, 2022 by decision of the Federal Council. So how to import medical devices in Switzerland?
Do not hesitate to read or re-read our article on the regulatory status of products
Guarantee the same level of quality, safety and efficiency as the European Union (EU)
With the entry into force of the new Swiss regulation on medical devices, the MRA should also have been updated. However, due to the general political context (abandonment of the negotiations on the institutional framework agreement between Switzerland and the EU), the European Commission did not pursue the update of the MRA, which was required from May 26, 2021.
New measures to be applied
Given the lack of update of the MRA, Switzerland has put in place measures to mitigate the negative effects of this development:
– the lack of access by Swiss authorities to the centralized European database for medical devices (Eudamed 3),
– the lack of collaboration in the field of market surveillance.
These measures include, for example, the staggering of deadlines for the appointment of a representative (“CH-REP“), the obligation for economic operators to register with Swissmedic, the reporting of serious incidents to Swissmedic, and the recognition in Switzerland of EU conformity certificates.
CH-REP is the key person for importing and marketing medical devices in Switzerland
The CH-REP is an Agent in Switzerland. It is a natural or legal person established in Switzerland who receives a written mandate from a manufacturer located abroad to act on behalf of the manufacturer for the purpose of fulfilling specific tasks under the ODim / ODiv.
If the manufacturer of a device is not based in Switzerland, its devices may only be placed on the market after an agent based in Switzerland has been appointed. This rule also applies to manufacturers based in the EU/EEA.
The representative must be identified on the packaging with the logo below, as well as his name and address.
Special points for importing and marketing medical devices in Switzerland ?
The regulation has defined 3 statuses of economic operators:
– IMPORTER CH
– DISTRIBUTOR CH
Only CH-REP and IMPORTER CH, must declare themselves to Swissmédic. So, how to import and market medical devices in Switzerland? First of all, you have to define your status of economic operator?
Would you like to be accompanied by experts to define your regulatory obligations to import and market your Medical Devices in Switzerland?
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