MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has published guidance dedicated to the medical device stand-alone software including applications. The scope of the guidance covers standalone software and applications intended to be marketed...
FDA
The Food and Drug Administration (FDA) has published guidance dedicated to non-clinical engineering tests and recommended labeling for intravascular stents and associated delivery systems. The document provides additional recommendations to be considered by the...
Kazakhstan
The National Center for Expertise of Medicines and Medical Devices (NDDA), Kazakhstan’s body responsible for the assessment of quality and safety of medical devices, has published an official notice on the rules for inspections with regard to medical devices. New...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the Breakthrough Devices Program, a special framework intended to facilitate the review of important submissions and accelerate the process of placing vitally important medical...
Kazakhstan
The National Center for Expertise of Medicines and Medical Devices (NDDA), a department of the Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan, a country’s regulating authority in the sphere of medical devices,...
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