Switzerland, with its nearly 9 million population, is recognized for its robust medical technology sector, bolstered by strong fundamentals and political stability.
The Mutual Recognition Agreement (MRA) between the European Union and Switzerland has been impacted by the EU's new medical devices (MDR) and IVDs (IVDR) regulations, necessitating compliance with Swissmedic Switzerland medical device registration requirements to legally sell devices under the Medical Devices Ordinance (MDO).
Switzerland's IVD market leads Europe in per capita spending (€88.9 in 2021). It is set to grow from $113.1M (2024) to $132.4M (2030) at a 2.4% CAGR, with reagents making up 68.88% of revenue (2024), reflecting strong investment in diagnostics.
Swissmedic is the medical device regulator in Switzerland. Pure Global can assist with Switzerland medical device registration and provide local representation, ensuring Swissmedic approval to sell in the Swiss market.
The classification of medical devices in Switzerland follows the EU's system, where it is based on the device's intended use and associated risk. This classification determines the specific registration and compliance requirements with Swissmedic.
To market medical devices in Switzerland, manufacturers outside of Switzerland must:
Our local partner’s expertise in Switzerland's medical device market offers you:
Guidance on device classification and determination of the appropriate regulatory pathway under the MDO.
Acting as your Swiss Authorized Representative includes swissdamed registration and more for a flat annual fee.
Pure Global offers flat-fee annual pricing for bundled Swiss Authorized Representative services and regulatory support, starting at $2,000/year. The flat fee includes document review, swissdamed registration, and Certificate of Free Sale (CFS) processing. Third party fees, when applicable, are not included.
Flat fee structure for medical devices and IVDs:
1 device or device group = $2,000/year
2-5 devices/groups = additional $500 per device per year (e.g., 5 devices = $4,000/year)
6-10 devices/groups = no additional cost (e.g., 8 devices - $4,000/year)
Contact us for a custom quote if you have 11+ devices.
A three-year contract is required to lock in the fees quoted above. However, other contractual arrangements are available. Use our Fee Calculator for an instant estimate and more information about flat fee terms.
Medical devices in Switzerland are classified following the EU's system, based on the device's intended use and associated risk. This classification determines the specific registration and compliance requirements with Swissmedic.
Foreign manufacturers must: Appoint a Swiss Authorized Representative (Swiss AR or CH REP) to act on their behalf. Ensure pre-market registration and compliance with Swiss medical device regulations under the Medical Devices Ordinance (MDO), facilitated by the Swiss AR. Ensure the Swiss AR reports vigilance to Swissmedic on behalf of the manufacturer.
The Swiss AR ensures compliance with Swiss regulations, facilitates communication, handles pre-market registration, and reports vigilance to Swissmedic, enabling the manufacturer to sell their medical devices in Switzerland.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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