Europe The second article addresses specific matters associated with the use of medical devices in healthcare institutions, including the obligations in the sphere of incident notification or direct import. Table of Contents Swissmedic, the country’s regulatory...
switzerland The first article provides a brief overview of the Swiss legislation in the sphere of medical devices, and also describes in detail the recent changes thereto. Table of Contents Swissmedic, a Switzerland’s regulatory agency in the sphere of healthcare...
EU MDR/IVDR SwissMedic, the Swiss regulating authority in the sphere of medical devices, has published a guidance document dedicated to the obligations of parties involved in operations with medical devices, other than manufacturers: authorized representatives, importers, and...
Europe Swissmedic, the Swiss agency for therapeutic products, announced the implementation of a new technical standard to be used when submitting a marketing authorization application for a medicinal product. The present document constitutes an improved version of the...
Europe The SwissMedic, the authority responsible for medical device regulations in Switzerland, has published, in coordination with the EU and MDR, updated regulations: new Medical Devices Ordinance (MedDO) and Clinical Trials for Medical Devices Ordinance (ClinO-MD). These...
