KSA
The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to companion diagnostic IVDs
European Union
The article provides a general overview of the UK regulatory framework for medical devices.
EU
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices under the existing legal framework.
Swissmedic
The article highlights the key points related to the regulatory requirements for combination studies intended to be carried out in Switzerland.
EU
The new article describes in detail specific aspects related to the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
