We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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