Therapeutic Products Act (TPA)
Overview
The Therapeutic Products Act (Heilmittelgesetz, HMG / TPA, SR 812.21) 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.
Key TPA Provisions Relevant to Medical Devices
The TPA contains several articles of fundamental importance to medical device regulation:
Article 3 — Definition of therapeutic products: Establishes that medical devices are therapeutic products subject to TPA oversight.
Article 9 — Hospital exemption: Allows healthcare facilities to manufacture and use custom-made devices in-house under specified conditions, subject to notification to Swissmedic.
Article 13 — Regulatory authority: Designates Swissmedic as the federal competent authority for medical device market surveillance and enforcement.
Article 82 — Enforcement powers: Grants Swissmedic authority to issue orders, conduct inspections, request information, and take safeguard measures to protect public health.
For the complete and authoritative text of all TPA articles, consult SR 812.21 on Fedlex.
Official Sources
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