CBRN
The article provides a brief overview of a special regulatory framework introduced for certain in vitro diagnostic medical devices.
CDC
The new article highlights certain specific aspects pertaining to the regulatory framework, emphasizing the key points to be taken into consideration.
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...
