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.
ANVISA
The new article covers the matters related to classification of personalised devices and provides additional clarifications in this respect.
ARTG
The new article describes in detail the applicable classification rules in-house in vitro diagnostic medical devices are subject to, as well as the relevant regulatory requirements to be applied depending on the classification.
FDA
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
FDA
The article provides an overview of the official guidelines dedicated to classification rules and requirements for medical devices intended to be marketed and used in the US. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating...
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