TGA Updating Guidance for In Vitro Diagnostics

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.

More information is here: www.fdanews.com/11-19-15-TGA-IVDs.pdf. — Jonathon Shacat