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In Medical Devices

Switzerland’s Therapeutic Products Act Revision: Industry Stakeholders Show Positive Support

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I. Overview of proposed key changes The Swiss Federal Act on Medicinal Products and Medical Devices (Swiss Therapeutic Products Act, TPA), which has been in force since 2002, is currently undergoing its third revision. The proposed changes are designed to improve the safety and quality of medicinal products and medical devices (therapeutic products). The changes will update the legal framework to match current scientific and technological standards, as well as international laws, especially those…

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In Medical Devices

Swiss Federal Administrative Court Confirms Alignment of Classification of Software Used for Contraception Between Switzerland and EU

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In brief In its decision of 12 September 2022 (C-1256/2020), the Swiss Federal Administrative Court (FAC) confirmed that interpretive software that uses indicators such as calendar days and body temperature to monitor fertile and infertile phases of a menstrual cycle to achieve natural conception or prevent undesired pregnancy, qualifies as a medical device. This means that such software is subject to a conformity certification procedure with a notified body. In its reasoning, the FAC primarily focused…

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In Healthcare Services

Switzerland Adopts New Human Genetic Testing Act

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In brief On 1 December 2022, Switzerland’s new Human Genetic Testing Act (HGTA) will enter into force. The new HGTA provides a comprehensive legal framework for all types of genetic testing (including direct-to-consumer genetic testing and lifestyle genetic testing) and implements stronger measures to protect privacy rights, prevent abuse of genetic data and ensure the quality of genetic tests and the interpretation of the results. As part of the comprehensive revision of the HGTA, the…

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