Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the classification of active medical devices (including software-based ones). The document issued in...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document on design control for medical devices. The document provides additional clarifications and recommendations to be...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document on reprocessing medical devices in healthcare settings. The document highlights the most important aspects...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to design control. The scope of the document covers such aspects as design input and design output. The...
EU MDR/IVDR
The Health Products Regulatory Authority (HPRA), the Irish regulating authority in the sphere of medicines and medical devices, has published a draft guidance document dedicated to new applications for wholesale distribution authorizations (WDAs), as well as...
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