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New to Swiss medical device regulation? These pages cover the foundations.
| Page | Covers |
|---|---|
| What is a Medical Device? | TPA Art. 4 / MedDO Art. 3 definition; intended purpose; software; accessories |
| What is Not a Medical Device? | Cosmetics, food, medicines, excluded software |
| MedDO vs IVDO | Two separate ordinances; which applies to your product |
| Regulatory Framework Overview | TPA → MedDO/IVDO → Swissmedic guidance; MRA relationship |
| Who Needs to Comply? | Manufacturer, CH REP, importer, distributor roles |
| Manufacturers | QMS, tech docs, conformity, post-market obligations |
| Swiss Authorised Representatives (CH REP) | Mandatory for non-Swiss; MedDO Art. 56–59; joint liability |
| Importers and Distributors | Verification duties; when importing triggers CH REP |
| Lifecycle of a Medical Device | Classification → Conformity → Registration → Post-Market |
| Glossary | Key Swiss regulatory terms in plain English |
Disclaimer
Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.