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.
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.
EU
The new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it.
Serbia
The article describes in detail the approach to be applied when requesting changes to the existing medical device registration.
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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