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Stakeholders recognized the need for the TGA “to take action to improve the current arrangements for custom-made medical device regulation, which are too broad,” the agency said. Read More
Draft legislation from the European Parliament calls for joint assessments of new health technologies including medical devices rather than the current system of individual assessments by EU member states. Read More
The agency advised that complete test reports are not necessary for special 510(k)s or for tests which have been provided a declaration of conformity to an appropriate agency-recognized consensus standard. Read More
Health Canada will issue manufacturers a list of medical devices associated with active medical device licenses and give them the opportunity to determine the 5-digit GMDN code for their devices. Read More
The European Commission provided further guidance for devicemakers on how to distinguish borderline devices and in vitro diagnostics in a new Version 1.19 of its manual on… Read More
The rejection “reflects the agency’s belief that the current processes in place at servicing facilities support continued quality, safety, and effectiveness of medical devices that undergo servicing,” the agency said. Read More