A closer look at Swissdamed and its implementation timeline: actor registration in 2024
In February 2024, the Swiss Agency for Therapeutic Products (Swissmedic) announced that the actor registration…
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Swiss regulatory updates that marked the beginning of the year
Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for carrying out the control tasks…
When are disinfectants regulated as medical devices?
In December 2023, Swissmedic published an informative document on regulations of disinfectants in Switzerland. The…
MedDO on products without an intended medical purpose
In November 2023, the Swiss Medical Devices Ordinances (MedDO and IvDO) were revised to guarantee…
Registration of medical devices in Switzerland: Swissdamed to be functional in 2024
Without a mutual recognition agreement between the European Union and Switzerland, medical devices and IVD…
Swissmedic inspects Class I manufacturers in Switzerland: results of market surveillance activities
Since 26 May 2021, manufacturers of class I medical devices must comply with the Swiss…
Latest changes in the EU: how the new transitional provisions impact the Swiss Medical Devices Ordinance
The initial transition periods foreseen by the Medical Devices Regulation (MDR) for legacy devices were…
Swiss requirements for combination products
The lack of a renewed Mutual Recognition Agreement (MRA) on the medical device legislation between…
Switzerland to accept FDA approved medical devices
On November 28, 2022, the Swiss Parliament reached a key decision by instructing the Swiss…
Swiss Database on Medical Devices, what to know?
Swissdamed, which stands for “Swiss Database on Medical Devices”, is a new database implemented by…