TGA — Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) was established to safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods. The organisation works with industry, consumers and health professionals and its international counterparts in order to effectively regulate increasingly complex medicines and medical devices resulting from rapid scientific and medical developments. To support the international
As a division of the Department of Health and Ageing, the TGA enforces the Therapeutic Goods Act 1989 and subordinate regulations.
Most dental product supplied in Australia is categorised as a “medical device” for regulatory purposes and the manufacture, export and supply within Australia of dental product is regulated by the TGA.
The TGA ensures that the Australian community has access, within a reasonable time, to therapeutic advances. The regulatory framework is based on a risk management approach designed to ensure public health and safety. The TGA also regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. It has a team of inspectors that audit manufacturing facilities around the world to ensure that products supplied in Australia are of high quality.
As the peak representative body for the dental industry, the Australian Dental Industry Association (ADIA) affords members the opportunity to engage with the TGA on the development of regulatory standards for the approval of dental product. At the request of the Australian Government, ADIA represents the dental industry on the:
TGA Therapeutic industry consultative committee
TGA Regulatory and technical forum for the devices sector
Medical device reforms reference group
ADIA's objective in its positive engagement with the TGA is to ensure that Australian business can supply dental product free from an unnecessary regulatory burden. The dental industry's contribution to the work of the forum is coordinated by the ADIA-DRC Dental Regulation Committee.
At an international level, the TGA works towards the harmonisation of the regulatory standards for the approval of medial devices, the TGA is the Australian delegate to the International Medical Device Regulators Forum (IMDRF).
To keep up to date with the dental industry’s engagement with the TGA, follow ADIA on Twitter @AusDental or contact the ADIA national office via email at dental.regulation@adia.org.au or telephone 1300 943 094 (internationally on +61 2 9319 5631).