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.
IMDRF
The new article describes the key terms and concepts used in adverse event reporting for medical devices.
Australia
The article briefly overviews the processes and procedures associated with applying for conformity assessment certification.
HSA
The article provides a general overview of the approach to be followed when preparing a submission associated with a medical device intended to be placed on the market in Singapore.
HSA
The new article outlines the scope of information to be included in the device description and executive summary sections of the submission.
