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.
MDCG
The new article provides an overview of the regulatory status of accessories and related products as set forth under the existing legal framework.
EU
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices under the existing legal framework.
Tanzania
The final article of the cycle provides clarifications regarding the remaining specific aspects addressed in the document, finalizing the overview of the existing legal framework and highlighting the key points to be taken into consideration by the parties involved.
