Australia
The article highlights the key points related to the regulatory status of boundary products in Australia.
EU
The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant matters.
FDA
The article highlights the key points related to the specific aspects to be considered when using real-world data to support marketing applications related to medical devices.
FDA
The article provides a general overview of the guidance document issued by the US authority and highlights the key points related to the existing legal framework.
SAHPRA
The article highlights the key points related to the licensing regime for medical device establishments.
