EDA
The new article provides further clarifications regarding the design of a clinical study, as well as the risk management approach to be followed.
EDA
The new article pays special attention to combination products as a separate category of medical devices, and also highlights the key points related to ethical considerations.
EDA
The new article explains in detail the approach to be followed with respect to safety reporting in the context of clinical investigations conducted in order to assess the safety and effectiveness of medical devices intended to be marketed and used in Egypt.
HPRA
The article provides a general overview of the regulatory requirements applicable to medical devices created and manufactured by healthcare institutions to meet their own internal needs.
ANVISA
The new article describes in detail different types of personalised medical devices and highlights the key points.
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