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The International Medical Device Regulators Forum (IMDRF) made some progress toward global harmonization of device standards at its most recent meeting — held for the first time as a virtual conference due to the COVID-19 pandemic. Read More
Health Canada is fast-tracking the review of submissions related to rapid antigen detection tests (RADTs) and nucleic acid tests and has released new guidance on antigen testing. Read More
Australia’s Therapeutic Goods Administration (TGA) said that, in light of delays due to the COVID-19 pandemic and limitations on the number of notified bodies designated under the European Medical Devices Regulation, devicemakers could see their conformance assessment documents lapse for their listed devices on Australia’s Register of Therapeutic Goods. Read More
The agency said that sensitivity below 80 percent will not be considered acceptable for authorization because the tests could produce too many false negative results. Read More
Sponsors that import or supply devices in Australia would need to verify that device manufacturers have assigned a UDI to their device and have placed it on the device, on labeling and on packaging. Read More
Effective Oct. 1, Australia’s Therapeutic Goods Administration is requiring devicemakers of Class I non-measuring, non-sterile devices to provide a declaration of conformity with their applications to list on the Australian Register of Therapeutic Goods (ARTG). Read More