FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the patient-reported outcome measures and the way they should be used in medical product development to support labeling claims. Together with the Patient Preference Information...
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 labeling rules for medical devices introduced by the...
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...
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