Australia and Oceania
Australia’s authority responsible for medical devices regulation, the Therapeutic Goods Administration (TGA), issued detailed guidelines on the regulatory approach to be applied to the test intended to identify the Coronavirus Disease 2019 (COVID-19). COVID-19 Test...
The Therapeutic Goods Administration (TGA), Australia’s authority responsible for medical devices regulation, issued guidance dedicated to thermometers and other temperature measuring devices in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19)....
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the improvement of the regulatory framework in the sphere of medical devices, issued guidance dedicated to the safety reporting in clinical investigations under the...
EU MDR/IVDR
The European Commission (EC), the EU body focused on the improvement and development of medical devices regulation, issued guidelines describing the way the EU-wide derogations for medical devices should be applied under the Medical Devices Regulation 2017/745 (MDR)....
FDA
The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance on supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions in the context of the outbreak of the...
The European Commission (EC), the EU body responsible for medical devices regulatory framework, announces amendments to the designation procedures related to the Notified Bodies (NBs), and also to the rules on the EU-wide derogations. EC New Regulations in Brief Both...
