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Medical devices
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University student educational materials
18 December 2013
View this presentation for information on:
- what are medical devices, and how they compare to medicines in terms of regulation
- the process for a device to get to market and how they are classified according to risk
- the essential principles and conformity assessment
- safety and performance of devices.
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
- The regulation of medical devices in Australia (Microsoft PowerPoint,8.41Mb)*
- The regulation of medical devices in Australia (pdf,590kb)*
Disclaimer
* These educational materials are provided by the TGA (a part of the Department of Health) solely for the purpose of providing general education on the TGA regulatory scheme. The materials should not be taken to be a detailed description of the scheme, or advice on the application of the therapeutic goods legislation in particular cases. Nor should they be taken to be statements of policy.
People requiring information or advice on the application of the therapeutic goods legislation in particular cases should make their own enquiries.
Whilst due care has been taken in their preparation, the Department of Health cannot guarantee, and assumes no legal liability or responsibility for the accuracy, currency or completeness of the information contained in these materials.
These materials are based on the scheme as it is in December 2013.