Saudi Arabia
The article provides a general overview of the regulatory requirements for medical devices developed by healthcare institutions to meet their internal needs.
Saudi Arabia
The new article highlights the critical points associated with the concept of intended use and clarifies the approach to be applied concerning risks associated with in-house medical devices.
Canada
The new article describes in detail the authority’s review process when assessing applications related to medical devices.
Saudi Arabia
The new article describes in detail the regulatory approach to be followed concerning the manufacturing process, post-market surveillance, and other aspects.
IMDRF
The article provides a general overview of the key terms and concepts used in adverse event reporting related to medical devices.
