FDA
The article provides a brief overview of the applicable regulatory requirements related to using real-world data in the context of submissions associated with medical devices intended to be marketed and used in the US.
FDA
The article provides a brief overview of the approach to be followed for the reports related to studies and reports associated with it.
HSA
The new article highlights specific points related to medical device registration in Singapore under the existing legal framework.
FDA
The article highlights the aspects related to the definition of shortage and the steps the authority takes to mitigate the associated risks.
EU
The article briefly overviews the European regulatory framework for clinical investigations.
HSA
The new article describes in detail the approach to be followed when applying for registration and marketing approval for Class A and B medical devices.
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