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.
HSA
The new article clarifies the scope of information to be included in the submission to ensure all the essential matters are adequately addressed, the submission is complete, and the authority has all the necessary information to make the regulatory decision.
