HSA
The new article outlines specific aspects associated with the registration of medical devices intended to be marketed and used in Singapore, emphasizing the most essential matters to be considered to ensure compliance with the requirements set forth under the existing legal framework.
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.
Serbia
The article describes in detail the approach to be applied when requesting changes to the existing medical device registration.
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