Swissmedic is the Swiss regulatory agency responsible for authorizing and supervising therapeutic products. Based in Bern, the agency started its activities in 1 January 2012, replacing the Interkantonale Kontrollstelle für Heilmittel (IKS). It was created by the Federal Act on Medicinal Products and Medical Devices and is attached to the Federal Department of Home Affairs, but functions as a autonomous agency, with its own budget.
Swissmedic is responsible for the authorization of health products, for licensing their manufacturing and wholesale. It also deals with clinical trials, establishing standards and monitoring the market of these products.
Swissmedic’s organizational structure is made up of 4 departments:
- Authorisation, dealing with case management, quality, preclinical and clinical reviews
- Market Surveillance, overseeing the safety of medicines, medical devices and market monitoring
- Licensing, in charge of clinical trials, inspectorates, certificates and licenses
- Legal Affairs, composed of the Legal Advisory Division, Legislation and Penal Division
Some of the most important European regulations for medical devices in the EU are:
- CONSOLIDATED Medical Device Directive (93/42/EEC)
- CONSOLIDATED Active Implantable Medical Devices Directive (90/385/EEC)
- View as web page
- Personal Protective Equipment Directive (89/686/EEC)
A full list of European regulations can be found here.
Medical Device Associations in Switzerland: