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Market Information
Switzerland's healthcare expenditure is one of the highest in the world, with a spending of $8049 per capita, which is much higher than the OECD average of $4986.
Market Trend: In Switzerland, each citizen is required to have their own private medical insurance, which funds the high costs of medical services and system.
Switzerland’s medical equipment market is estimated to have a revenue of $4.85 billion in 2024.
Medical Device Regulation
Classification, Fees, Timeline
Product Registration Routes
Class I, IIa, IIb, III, AIMDs
All Medical Devices need to have an appointed European Authorised Representative to export their devices to Europe, and vice versa. The devices have to be in compliance with the Medical Device Ordinance (MedDo). The devices need to be affixed with the Unique Device Identifiers (UDI) according to the timelines,
- from 26 May 2021 for implantable devices and Class III devices
- from 26 May 2023 for Class IIa and IIb devices
- from 26 May 2025 for Class I devices
- 2 years after the dates given letters a-c for the relevant product class for reusable devices
Useful Information
Validity of License: 5 years
License transfer: Change of Registration application needed.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
Quality System: ISO 13485:2016
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