EU MDR/IVDR
The article provides an overview of the guidance document explaining how Article 97 MDR should be applied to legacy devices. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices,...
FDA
The new article describes how clinical data should be handled and highlights the key points to be considered in this respect. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
FDA
The new article highlights the key points related to potential failure of a responsible party to comply with a requirement to conduct a post-approval study, and also to the situations when information about post-approval studies is being disclosed. Table of Contents...
Asia
The article provides an overview of the regulatory requirements in the sphere of adverse event reporting. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document...
FDA
The new article highlights the aspects related to the measures intended to improve the accuracy of the study results and address potential bias. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Canada
The new article describes in detail the aspects related to the submission of clinical evidence in the context of applications for marketing approval. Table of Contents Health Canada, a country’s regulatory agency in the sphere of healthcare products, has published a...
