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Who’s Who? The TGA

28 April 2010

So you may be familiar with what a medical device is, but how much do you know about the processes involved in making a device available in Australia? Probably not a lot, because to describe it as ‘complex’ is a massive understatement.

There are numerous government departments and processes involved, each of them with a different acronym.

The Therapeutic Goods Administration

The first step to getting a device introduced in Australia is to have it registered with the Therapeutic Goods Administration (TGA).  The TGA explains its responsibilities as “a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances”  Their website is here: www.tga.gov.au

What does this mean for you?

In a nutshell, it means that if your doctor has recommended you receive a particular medical device, then you know it has been reviewed by the TGA, and deemed to meet acceptable standards in regards to safety and effectiveness.  Devices that meet the TGA’s requirements are entered on the Australian Register of Therapeutic Goods (ARTG).

It is important to understand that entry onto the ARTG does not mean that the treatment is automatically available in the public health system under Medicare, or that it is automatically or immediately funded by private health insurance.  Government or private health insurance funding for products requires separate applications to groups other than the TGA.  So it is possible for products to have been registered by the TGA, but not funded.  In these cases, if a patient wants the device they may have to pay some or all costs out-of-pocket.

The process to have something entered on the ARTG is again, complicated a one.  I’m going to work through it and try to make it simple for everyone to understand – but that is a challenge for a future post!

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