Legislation & Regulations
The legislative backbone of Swiss medical device regulation.
| Page | Covers |
|---|---|
| Therapeutic Products Act (TPA) | TPA (SR 812.21) structure, key articles, Swissmedic mandate |
| Medical Device Ordinance (MedDO) | MedDO (SR 812.213) structure, all annexes summary, entry into force |
| IVD Ordinance (IVDO) | IVDO (SR 812.219) scope, relationship to IVDR, transitional timeline |
| Clinical Investigations Ordinance (ClinO-MD) | ClinO-MD (SR 810.305), scope, BASEC ethics, Swissmedic authorisation |
| Related Legislation | Transplantation Act, Radiation Protection Act, nFADP, cantonal health laws |
| MRA with EU — Current Status | CH–EU MRA Chapter 4, operational status, practical impact on market access |
| How to Read Swiss Legislation | Fedlex, SR numbers, official languages, Fedlex search tips |
swissdamed registration
swissdamed device registration is mandatory from 1 July 2026 for all devices/systems/procedure packs placed on the Swiss market. A transitional period to register existing market devices