The document discusses regulations for in vitro diagnostic (IVD) medical devices in Australia. It provides an overview of the current regulatory framework, which implemented a new four-tier classification system in 2010 based on risk. All commercial IVDs and high-risk in-house IVDs must be included in the Australian Register of Therapeutic Goods. The document announces reforms planned for 2015 to simplify requirements for certain in-house IVDs and provides guidance for laboratories on identifying devices and complying with regulations by 2017 deadlines.