United States
The new article highlights the aspects related to how the regulatory context should be considered when assessing real-world evidence and real-world data.
ACTD
The article provides a brief overview of the approach to be applied concerning the classification of medical devices. It highlights the key points to be taken into consideration in this respect.
FDA
The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
HSA
The new article describes in detail the approach to be followed when applying for registration and marketing approval for Class A and B medical devices.
EU
The article describes in detail the regulatory approach to be applied in the context of the importation and distribution of medical devices in the EU, focusing on the obligations of the parties involved.
