Feb 26, 2024
United States
The article provides additional recommendations related to the description of devices to be included in premarket submissions to ensure the authority has the comprehensive information it needs to complete the review.
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Feb 26, 2024
United States
The present article outlines the key points related to the existing legal framework and explains the basics of the approach to be followed.
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Feb 26, 2024
EU
The article provides a general overview of the regulatory concepts associated with demonstrating substantial equivalence for specific products intended to be marketed and used in the EU.
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Feb 23, 2024
EU
The new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it.
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Feb 23, 2024
Serbia
The article describes in detail the approach to be applied when requesting changes to the existing medical device registration.
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Feb 23, 2024
FDA
The new article highlights the aspects related to the applicability scope, and also provides definitions of the key terms and concepts.
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