Australia’s Therapeutic Goods Administration is updating guidance materials on in vitro diagnostic medical devices, following new amendments to the regulatory framework.
The TGA also is updating forms as a result of changes to the electronic application process for Class 4 in-house IVDs and the notification process for Class 1 to 3 in-house IVDs.
Laboratories with Class 4 in-house IVDs before July 1, 2016, will have until July 1, 2017, to apply for inclusion in the Australian Register of Therapeutic Goods.
New Class 4 in-house IVDs introduced after June 30, 2016, must be included in the ARTG before they can be used by the laboratory to issue patient results.
Notifications for Class 1 to 3 in-house IVDs must be submitted by July 1, 2017.