Therapeutic Goods Administration
Medical device market regulators in Australia and New Zealand have implemented a series of projects involving adverse event notification, device recall information and quality system inspections as part of the countries' long-term effort to establish a single regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).
The Therapeutic Goods Administration (TGA), Australia’s medical device market regulator, has launched a new searchable database of adverse event information, the Database of Adverse Event Notifications (DAEN), available to the public.
Australia’s Therapeutic Goods Administration (TGA) has published proposed changes to upcoming in vitro diagnostic (IVD) regulations for comment ahead of a proposed final implementation date of July 2014.
High-level components of the new Australian IVD regulatory scheme include:
Health ministers of Australia and New Zealand report progress toward launching a joint regulatory body for oversight of medical devices in both countries. Once operational, the new system will replace both the Australian Medicines and Medical Devices Safety Authority.
The governments of Australia and New Zealand are setting up a single regulatory body to oversee therapeutic goods including medical devices and pharmaceuticals across both their countries.