About the Therapeutic Goods Administration (TGA)

TGAThe Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.

The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.

The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.

The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices.  TGA investigates reports received by it to determine any necessary regulatory action.

How medical devices are regulated in Australia

The Office of Devices Authorisation (ODA) is the area within the TGA responsible for the pre-market regulation of medical devices, while the Office of Product Review (OPR) is responsible for post-market regulation of all therapeutic goods.

Australian regulatory guidelines for medical devices (ARGMD)

Version 1.1, May 2011

Download “TGA Guidelines” devices-argmd-01.pdf – Downloaded 168 times – 2 MB

Essential principles checklist (medical devices)

For the manufacturer to demonstrate compliance to the TGA regulatory scheme, refer to the Essential Principles Checklist for their medical devices.

The product requirements (the Essential Principles) for the quality, safety, and performance of the medical device must be complied with:

  • before the device is supplied to the market in Australia, and
  • on an ongoing basis while the device is supplied to the market in Australia

The majority of medical devices must be included in the ARTG before being made available for supply in Australia. The ARTG can be accessed via the TGA website .

Last Updated: 2016-02-17

TGA Regulatory Guidelines for Medical Devices
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