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.
List of FSCAs
News
Regulation of medical devices
- Frequently Asked Questions
- Designated bodies
- Standards and common specifications
- Foreign inspections
- Applicable EU legal acts
- Roundtable on Medical Technology (RTMT)
- Legal framework
- Information from the European environment
- International Medical Device Regulators Forum (IMDRF)
- Product groups without an intended medical purpose
swissdamed
- Overview
- Registering economic operators (CHRN)
- Unique Device Identifiers (UDI)
- Support swissdamed
- Questions and answers
- Release Notes
Clinical trials
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
- Exemption authorisations
- New transitional provisions
- Import, sale and distribution
Reporting incidents & FSCAs (vigilance)
