Therapeutic Goods Administration (TGA)
Esco medical products are registered in the medical devices category of the TGA (both Australia and New Zealand), which means you can be assured of the best quality, and that our products meet the appropriate standards for Australian and New Zealand use. Many government tenders list TGA registration as a requirement.
Essentially therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. The ARTG is a computer database of information about therapeutic goods for human use approved for supply in, or exported from, Australia.
The Therapeutic Goods Act 1989, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the ARTG, including advertising, labelling, product appearance and appeal guidelines. Some provisions such as the scheduling of substances and the safe storage of therapeutic goods, are covered by the relevant State or Territory legislation.
The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing and is responsible for administering the provisions of the legislation.
The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. At the same time the TGA aims to ensure that the Australian community has access, within a reasonable time, to therapeutic advances.
Regulating medical devices
The regulation of medical devices includes the following features:
- classifying the medical device based on different levels of risk;
- assessing compliance with a set of essential principles for their quality, safety and performance;
- implementing appropriate regulatory controls for the manufacturing processes of medical devices;
- including the medical device in the ARTG; and
- implementing a comprehensive post market vigilance and adverse incident reporting program.