Advocacy — TGA Product regulation

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. As a division of the Department of Health, the TGA enforces the Therapeutic Goods Act (Cht) 1989 and subordinate regulations.

Most dental products supplied in Australia are 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 business organisation representing manufacturers and suppliers of quality dental products, 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 policy engagement in dealing with the TGA is ti secure a regulatory framework for dental products that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.

• TGA Regulatory system reforms
• TGA medical device regulation

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).

ADIA provides leadership, strategy, advocacy and support. Our members set our agenda, fund our activities and directly benefit from the results. To ensure that the advice and guidance ADIA provides the TGA on matters associated with medical device regulation members determine ADIA policy through the ADIA-DRC Dental Regulation Committee. On issues specific to the dental laboratory sector members participate in the ADIA-LIG Laboratory Interest Group.