Feb 21, 2024
EU
The article highlights the aspects related to studies involving combination products, the ones not initially intended to assess the safety and performance of a medical device, and other specific cases.
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Feb 21, 2024
United States
The new article highlights the aspects related to how the regulatory context should be considered when assessing real-world evidence and real-world data.
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Feb 21, 2024
ACTD
The article provides a brief overview of the approach to be applied concerning the classification of medical devices. It highlights the key points to be taken into consideration in this respect.
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Feb 21, 2024
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.
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Feb 19, 2024
FDA
The article provides a brief overview of the approach to be followed for the reports related to studies and reports associated with it.
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Feb 19, 2024
HSA
The new article highlights specific points related to medical device registration in Singapore under the existing legal framework.
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