Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a detailed guidance document describing the rules to be applied when determining the class of an in vitro diagnostic medical device (IVDD). The document provides an...
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 medical device data systems, medical image storage devices, and medical image communications devices. The...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to incident reporting under the new regulatory framework, which becomes effective from June 23, 2021. 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 developed a guidance document dedicated to the device software functions and mobile medical applications. The latest version of the policy was...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a Q&A document dedicated to the regulatory requirements for registration in EUDAMED, the new EU-wide database, of actors other...
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...
