BfArM
The article provides an overview of the authorization process for clinical trials involving medical devices to be conducted in Germany.
Canada
The article describes the approach to be applied to innovative medical devices utilizing machine-learning technology.
EU
The article provides a general overview of the regulatory approach to be applied with respect to certain CE-marked devices.
Great Britain
The new article outlines the list of questions raised by the regulating authority in the context of the initiated consultation and also provides definitions of the most important terms and concepts used.
Great Britain
The new article describes in detail the new regulatory policy for in vitro diagnostic medical devices as suggested by the UK authority.
Great Britain
The article highlights the key points associated with the concept of common specification requirements for certain products allowed to be marketed and used in the UK.
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