Unlike medicinal products, medical devices do not undergo an official authorisation procedure. Swissmedic's focus in the area of medical devices is thus on effective market surveillance.
Clinical trials
- Authorisation procedure
- Authorisation practice as of May 2021
- Submissions during ongoing clinical trials
- How to submit ?
Market access
- Obligations for authorised representatives, importers and distributors
- Unique identification no. (CHRN)
- Swiss authorised representative (CH-REP)
- Unique Device Identifiers (UDI)
- Notification of medical devices
- Notification of IVD medical devices
- Notification of devitalised human tissue
- Exemption authorisations for non-conforming medical devices
- Import, sale and distribution
