HPRA
The new article describes in detail the requirements in-house IVDs are subject to.
Australia
The new article describes the approach to be applied with respect to mandatory recalls initiated in order to avoid the customers’ exposure to healthcare products that could potentially be harmful when used for the intended purpose.
MHRA
The article provides a general overview of the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in the United Kingdom. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK...
Asia
Oman’s Directorate of the General Pharmaceutical affair and Drug Control (DGP&DC) has published draft guidance dedicated to medical devices bundling/grouping criteria. The document provides an overview of existing legislation and clarifications regarding the...
North America
The difference between CLIA and FDA standards
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