Swissmedic is supplementing its existing guidance documents with a structured collection of FAQs on key requirements and procedures relating to the risk management of human medicinal products
The registration of devices according to Art. 90 IvDO will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026.
The registration of MD-DEVIT products according to Art. 108 MedDO will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026
The registration of devices, systems, and procedure packs according to Art. 108 MedDO will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026
With the new «Schweizerische Gute Praxis der Materiovigilance im Spital» (GPMV-Spital), Swissmedic is publishing a guideline designed to support hospitals, professionals working there and vigilance contact persons for medical devices in the correct implementation of materiovigilance
To clarify the distinction under therapeutic products legislation between manufacture and preparation for administration, Swissmedic decided, with effect from 1 June 2025, to make an urgent amendment to the Good Manufacturing Practice rules for medicinal products in small quantities as stated in the Swiss Pharmacopoeia (Ph. Helv.)
