It is always an advantage to look beyond your own nose. And not only beyond the borders of Europe, but far away - as far as Australia. The continent prides itself on its excellent healthcare system and considers itself well equipped to deal with the consequences of a growing population. We want to know more about it. What do Australians do differently or better than we do in Europe?The regulatory body
The regulatory authority is the Therapeutic Goods Administration (TGA), it is part of the Australian Government Department for Health and Ageing. The TGA is also the conformity assessment body for Australian manufacturers and some foreign sites. In general, the Australian regulatory system is a combination of GHTF (Global Harmonisation Task Force) and European elements by leveraging Notified Body issued CE marking certificates and the enforced control by TGA. The system is therefore largely based on the GHTF principles. Before a medical device can be marketed in Australia, an Australian Register of Therapeutic Goods (ARTG) listing number needs to be assigned. The Global Medical Device Nomenclature (GMDN) Codes are required with the ARTG listings.
The Australian regulatory system is formally based on the European regulatory system. Medical devices including IVD devices are assessed against the Essential Principles and in line with their intended purpose and risk-based classification. The regulatory framework for medical devices spans the life of the device and includes:
Exhibitor Data Sheet
- Pre-market assessment: conformity assessment
- Market authorisation: inclusion in the ARTG
- Post-market monitoring: continuing compliance with all regulatory, safety and performance requirements and standards.