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 reprocessing medical devices in healthcare settings. In particular, the document provides additional...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a Questions-and-Answers document dedicated to the Electronic Medical Device Reporting (eMDR). The document is intended to provide...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has developed a guidance document dedicated to the device software functions and mobile medical applications. The latest version of the policy was...
Saudi Arabia
The Saudi Food & Drug Authority (SFDA), the country’s agency responsible for regulations in the sphere of medical devices, has published a second version of its guidance on approval requirements for medical device advertising. The current version of the document...
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 software validation. The document describes the general principles to be applied and also provides...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices intended to be marketed and used in the EU, has published a joint implementation and preparedness plan for the In Vitro Diagnostic medical devices...
