Apr 12, 2024
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.
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Apr 12, 2024
HSA
The new article outlines the scope of information to be included in the device description and executive summary sections of the submission.
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Apr 12, 2024
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.
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Apr 12, 2024
EU
The article provides a general overview of the approach to be followed when creating a clinical investigation plan for medical devices.
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Apr 12, 2024
EU
The new article outlines the scope of general information to be covered by a clinical investigation plan a party responsible for the inquiry should prepare.
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Apr 12, 2024
EU
The new article describes the way study benefits and objectives should be reflected in a clinical investigation plan.
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