EU
The article provides an overview of the regulatory approach to be applied with respect to clinical investigations involving medical devices in the context of exemptions.
United States
The article provides a brief overview of the existing legal framework associated with the third-party review.
SFDA
The article provides an overview of the regulatory framework for sample collection.
United States
The highlights the aspects to be taken into consideration in order to ensure the real-world data used to support regulatory submissions is relevant and reliable.
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.
