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Switzerland: one year's experience with new regulations and a new agency: a look at some of the developments of 2002 from the regulator's perspective. (market).

Medical Device Technology, March, 2003 by Voelksen, Rainer

Accommodating major changes

Since January 2002, all health-care products in Switzerland have been regulated by one federal law on medicinal products and medical devices (as well by several federal ordinances) under the authority of Swissmedic, the new federal Swiss Agency for Therapeutic Products. This Agency is the result of the merger of the former intercantonal agency for drug control, IKS, and some units of the still existing Federal Office of Public Health.

Major changes took place in 2002 with the implementation of the In Vitro Diagnostics (IVD) Directive 98/79/EC ...

 

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