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.
Market access
- Obligations for authorised representatives, importers and distributors
- Registering economic operators (CHRN)
- Swiss authorised representative (CH-REP)
- Unique Device Identifiers (UDI)
- Notification of medical devices
- Notification of IVDs
- Notification of devitalised human tissue
- New transitional provisions
- Exemption authorisations
- Import, sale and distribution
Reporting incidents & FSCAs (vigilance)
