Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published an updated guidance document dedicated to personalized medical devices (including 3D-printed devices). The document constitutes a...
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 dedicated to Brain-Computer Interface (BCI) devices. The present article address aspects related to the...
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...
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device recalls. The document provides guidelines to be followed by medical device manufacturers with regard to their products...
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 dedicated to medical device reporting. The document...
