Swissmedic Switzerland Medical Device Registration
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).
Meeting Swissmedic Requirements
Regulatory Authority
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.
Classification
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.
Key Requirements
To market medical devices in Switzerland, manufacturers outside of Switzerland must:
- Appoint a Swiss Authorized Representative (Swiss AR or CH REP) to act on their behalf. The Swiss AR is responsible for ensuring the manufacturer reports vigilance to Swissmedic.
- Ensure pre-market registration and compliance with the MDO, facilitated by the Swiss AR.
Tailored Support for Market Entry
Our services are designed to streamline your entry into the Swiss medical device market:
Guidance on device classification and determination of the appropriate regulatory pathway under the MDO.
Acting as your Swiss Authorized Representative, managing pre-market registration and ensuring ongoing compliance with Swissmedic requirements.
Frequently
Asked Questions
What is the primary regulatory authority for medical device registration in Switzerland?
The primary regulatory authority for medical device registration in Switzerland is Swissmedic. Pure Global can assist with navigating Switzerland medical device regulations to ensure Swissmedic approval for selling medical devices in the Swiss market.
How are medical devices classified in Switzerland?
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.
What are the key requirements for foreign manufacturers to market medical devices in Switzerland?
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.
Why is appointing a Swiss Authorized Representative important for foreign manufacturers?
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.
We Provide Access To 28+ Markets Worldwide
Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.
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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.