Saudi Arabia
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the approach to be applied for bundling/grouping medical devices intended to be marketed and used in the...
FDA
The Food and Drug Administration (FDA) has published guidance dedicated to the medical device submissions under the Q-Submission program. The document describes the regulatory requirements introduced under the appropriate framework and also provides medical device...
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the regulatory requirements related to the cybersecurity aspects associated with medical devices. The document...
EU MDR/IVDR
The European Commission (EC), the EU body responsible for medical device regulations, has published a Q&A document dedicated to in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19. The guidance is intended to provide...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a consultation paper dedicated to the suggested regulatory approach with regard to the nanomaterials used in medical devices. The document...
