EDA Guidance on Preclinical Testing and Clinical Investigations: Overview
The article outlines the key points associated with the testing medical devices should undergo in order to be allowed for marketing and use in Egypt.
The article outlines the key points associated with the testing medical devices should undergo in order to be allowed for marketing and use in Egypt.
The new article provides further clarifications on the applicable classification system, as well as testing requirements to be considered.
The new article explains the approach to be applied with respect to clinical investigations.
The new article provides further clarifications regarding the design of a clinical study, as well as the risk management approach to be followed.
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.
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