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Medical Device Regulatory
Requirements for

Updated: 4/04/02. The new Law on Therapeutics came into force on January 1, 2002. See report for more details.

Disclaimer: The information contained on this website is derived from public sources and is current to the best of our knowledge. For detailed and definitive information about a country's laws and policies, the government of the country concerned should be consulted.

While Switzerland is not a member of the European Union (EU) nor the European Economic Area, it recognizes the CE Marking and transposed the EU Medical Devices Directive into national law in 1996.

The Swiss Federal Law on Medicinal Products and Medical Devices (known as the Law on Therapeutic Products) and the revised Medical Devices Ordinance (MDO) came into force on January 1, 2002. It lays out the rules for the authorization, production, quality control and market supervision of therapeutic products and for national and international cooperation between the authorities working in the therapeutic products sector. In the case of medicines, the new law enables the former cantonal regulations to be converted into federal legislation. Henceforth all regulations are legally binding throughout Switzerland and can be enforced by Swissmedic, the Swiss Agency for Therapeutic Products, as a governmental agency, simultaneously. The Swiss government, through Swissmedic, is now responsible for all therapeutic products (medicines and medical devices). It is no longer possible for the cantons to grant licences for medicines unilaterally.

In the area of medical devices, the new therapeutic products legislation:

- closes loopholes in the law regulating devices

- encourages the safe use of medical devices

- achieves improved harmonization with EC law

- enables implementation of the bilateral agreements with the EC

- redefines the authority of the Confederation and the Cantons in specific areas.

The Medical Devices Ordinance (MDO, SR 819.124) regulates medical devices at the Federal level, and transposes the requirements of the EU Medical Device Directives into Swiss law. The Medical Devices Unit of the Swiss Federal Office of Public Health (SFOPH) has the mandate to enforce the Ordinance. Medical Devices may only be placed on the market in Switzerland by manufacturers and importers if they comply with the MDO with regard to features of the product, designation of product, packaging, product information, training and publicity, vigilance system reporting, market oversight and maintenance measures.

With the new law, more products are considered as medical devices:

a) In vitro diagnostic medical devices

The new Therapeutic Products legislation replaces the existing Ordinance on In-vitro Diagnostic Medical Devices and Cantonal legislation, and now include products which were not regulated before. The requirements of the European Directive 98/97/EC are thus transposed into Swiss legislation. The duties of placers on the market apply immediately, especially that of device monitoring and the reporting of adverse incidents and recalls.

b) Medical devices incorporating stable derivates from human blood or human plasma

The requirements of the European Directive 2000/70/EC are now transposed into Swiss legislation. The duties of placers on the market (importers, manufacturers, wholesalers, retailers and other points of issue) apply immediately. However, for the modification of devices there is a transition period until December 2005.

c) Medical devices incorporating components of human tissue rendered nonviable

Until now, these products were not regulated in Switzerland. A European Directive for these products is not available. Switzerland is now introducing requirements with respect to notification, device monitoring and compliance monitoring. These apply immediately.

You may find additional information on importing medical devices into Switzerland at the Guide to the Swiss Medical Devices Ordinances.

For more information on the new Federal law and for registration and certification of medical devices, please contact:

Swiss Agency for Therapeutic Products
Division of Medical Devices
Erlachstrasse 8
CH-3000 Bern 9, Switzerland
Tel: (+41-31) 323 22 51
Fax: (+41-31) 322 76 46
E-mail: medical.devices@swissmedic.ch
Website: http://www.swissmedic.ch

For additional information on the medical industry sector in Switzerland, please contact:

Zurich America Center
Elisabeth Mbitha-Schmid
U.S. Commercial Service
Dufourstrasse 101
CH-8008 Zurich, Switzerland
Tel: (+41-1) 422 20 70
Fax: (+41-1) 382 26 55
E-mail: EMbithas@mail.doc.gov
Website: http://www.uscom.ch


Last updated on 5-2-05 by JF

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