Authorised Representative
What makes Switzerland significant for Medical Device Manufacturers?
Switzerland is a premier destination for medical device manufacturers relying on sophisticated micromanufacturing or advanced precision techniques. This appeal is evident in Switzerland's choice of...
Nomenclature of Medical Devices
‘Medical devices’ is an umbrella term that includes products for the prevention, diagnosis, and treatment of numerous diseases. Medical devices require an internationally accepted naming to identify the various types and categories. Nomenclature of medical devices helps understand the medical device’s risk class, definition, and use.
Labelling Requirements – Swiss Authorized Representative
Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple...
Swiss Manufacturer Obligations
1. Manufacturers outside Switzerland will need to appoint Swiss AR. 2. The Manufacturer will use commercially reasonable efforts to update its technical documentation for the devices, to comply with...
Switzerland AR Responsibilities
Obligations of the Switzerland AR Responsibilities 1. Verify the DoC and technical documentation have been drawn up and where necessary conformity assessment procedure has been carried out. 2. Keep...
Swiss Regulation QA WHITE PAPER
MEDICAL DEVICE REGULATION UPDATE IN SWITZERLAND 1. Who is responsible for medical device regulation in Switzerland? The Swiss Agency regulates medical devices for Therapeutic Products (Swiss medic)...
Switzerland Medical Device Regulations
Switzerland Market Situation As the Institutional Agreement is missing (InstA) is missing, the EU has not updated the Mutual Recognition Agreement (MRA) No barrier-free access to the EU internal...
Switzerland Authorised Representative
Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturer Responsibility Ensuring medical devices are placed on the market is in accordance with the requirement of the...