Jan 27, 2023
EU MDR/IVDR
The article provides an overview of the FAQ document addressing the key points related to notifications for medical devices. Table of Contents SwissMedic, a country’s regulating authority in the sphere of healthcare products, has published a guidance...
Read More
Jan 24, 2022
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...
Read More
Jan 13, 2022
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...
Read More
Sep 3, 2021
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...
Read More
Jul 17, 2020
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...
Read More