Regulatory
Life sciences companies looking to make therapies and medical devices available in Australia are urged to learn about the Therapeutic Goods Administration (TGA) regulations. This page gives an overview of the TGA, details its approach to regulation and provides tips for achieving compliance.
The TGA is a division of the Australian Government Department of Health. The agency is responsible for regulating the supply, import, export, manufacture and advertising of therapeutic goods available for supply in Australia. Australia TGA regulations are in place to ensure that therapeutic goods are high quality, safe and fit for their intended purpose.
Therapeutic goods comprise a wide range of items. These include bandages, vitamin tablets and sunscreens as well as goods for treating serious conditions such as prescription medicines, vaccines, blood products and surgical implants. The lawful supply of any therapeutic goods in Australia requires that the product is included on the Australian Register of Therapeutic Goods (ARTG).
There are numerous medical device types. Some have short life cycles while others are continually improving. The TGA medical device regulations are based on criteria such as the device’s purpose and degree of risk to users of the device and patients. Manufacturers are required to apply, and document, a conformity assessment to demonstrate the quality, safety and performance of a device.
Documentation is a critical element in medical device and in vitro device (IVD) regulation. The TGA has guidelines for which documents are needed and when while seeking approval for devices. Achieving TGA compliance is highly dependent on your ability to provide comprehensive, complete and accurate documentation throughout the life cycle of your medical device.
Part of the TGA’s medical device regulations includes a comprehensive adverse event reporting program. This involves assessing the evidence of the risks compared to the benefits. For instance, how likely is the device to fail either accidently or deliberately? Given the variety of device types and purposes, all risks must be identified and managed according to the nature of the device.
According to Australian regulatory guidelines, health care-related products are expected to consistently maintain a high standard of quality throughout their life cycle. Once a product is approved, the agency continues to monitor it through various vigilance activities. This means manufacturers should pursue postmarket quality management and continuous improvement.
Guide your company to successful compliance with TGA regulations.
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