link Collection

Find the most important links about medtech regulations from the authorities here.

Links of national authorities


Swissmedic is the Swiss Regulatory and Supervisory Authority for Medicinal Products and Medical Devices. Swissmedic's website provides information (incl. links) on relevant legal foundations and competent authorities. It also contains information regarding other issues such as the authorisation of medical devices, clinical trials, as well as market control and monitoring.

Medical devices

Federal Office of Public Health

Switzerland has had national regulations on medical devices in place since 1996. The field of medical technology is regulated by the Federal Law on Medicinal Products and Medical Devices (Therapeutic Products Act, HMG) and its associated ordinances.

Medical devices

State Secretariat for Economic Affairs – SECO

Switzerland is integrated into European market surveillance and the European internal market for medical devices via the Switzerland-EU Mutual Recognition Agreement (MRA, AS 2007 713). Switzerland, represented by SECO, is negotiating the adaptation of the MRA with the EU (Section 4) in order to establish mutual obligations according to international law.

Mutual Recognition Agreement

Links of the European Commission

In the European Union (EU), Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-vitro Diagnostic Medical Devices (IVDR) entered into force on 26 May 2017. The dates of application were 26 May 2021 (MDR) and 26 May 2022 (IVDR). Both EU regulations are directly applicable in the member states, and are binding.

Dr. Daniel Delfosse

Vice Director

Head of Regulation & Innovation

+41 31 330 97 74