Australia
The article provides an overview of the regulatory requirements various sterility products are subject to in order to be allowed for marketing and use in Australia.
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.
FDA
The article provides a brief overview of the regulatory approach to be applied with respect to certain tests intended to be used in the context of an emergency.
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