Therapeutic Products Act (TPA)
Overview
The Therapeutic Products Act (Heilmittelgesetz, HMG / TPA, SR 812(a).21) is the primary Swiss legislation governing all therapeutic products — including medicinal products, blood products, and medical devices. It provides the statutory authority for the MedDO and IVDO and establishes Swissmedic as the national regulatory authority.
Key TPA Provisions Relevant to Medical Devices
This article should be verified in the current TPA (SR 812.21) text on Fedlex; the specific article number for compassionate use may differ. Recommend checking Fedlex directly for the authoritative article reference.
2020 TPA Revision
The TPA was substantially revised in 2020 to provide the statutory basis for the new MedDO and IVDO, aligning Swiss medical device regulation with EU MDR/IVDR requirements. Key changes included: new definitions; updated market access framework; enhanced vigilance and post-market provisions; strengthened Swissmedic enforcement powers.
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.