Asia
The new article highlights the key points related to reporting adverse events associated with in vitro diagnostic medical devices and also describes the applicable reporting timelines. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory...
EU MDR/IVDR
The new article highlights the aspects related to non-conformity which does not impose unacceptable risks to health and safety. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for medical...
FDA
The new article addresses the aspects related to the principles to be followed with respect to voluntary reporting, and also describes the approach the authority applies when determining the eligibility criteria to be considered. Table of Contents The Food and Drug...
Canada
The new article highlights the aspects related to situations when clinical data is not needed, as well as to the changes to medical devices and amendments to the respective applications. Table of Contents Health Canada, a country’s regulating authority in the sphere...
FDA
The new article outlines the key points of the newly issued guidance document addressing the matters related to malfunction reporting. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
Brazil
The new article addresses the aspects related to the regulatory requirements to be applied with respect to the software products intended to be used for various purposes, including diagnosing and interaction with laboratory equipment. Table of Contents The Brazilian...
