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What is the TGA approval process (Australia’s Therapeutic Goods Act)?
With a well-developed health system, growing population and steadily increasing spending in the health sector, Australia is a promising market for the manufacturers of medical devices.
In October 2002, the new Therapeutic Goods Act (TGA) came into effect in Australia. The act is founded on the harmonised model developed by the Global Harmonization Task Force (GHTF) with regulations largely corresponding to those in the EU.
The TGA applies an extensive procedure to verify whether applicants meet the conformity requirements of Australia. If TÜV SÜD experts complete the conformity assessment procedure and confirms a positive outcome, the TGA issues the relevant certificate of conformity. As regulations in Australia are similar to those included in the EU directives for medical devices, the registration of products already certified in the EU involves only minor costs and efforts.
The TGA considers MDSAP audit reports when deciding the outcome of a conformity assessment route and the necessity of an audit by TGA.
In October 2002, the new Therapeutic Goods Act (TGA) came into effect in Australia. The act is founded on the harmonised model developed by the Global Harmonization Task Force (GHTF) with regulations largely corresponding to those in the EU.
The TGA applies an extensive procedure to verify whether applicants meet the conformity requirements of Australia. If TÜV SÜD experts complete the conformity assessment procedure and confirms a positive outcome, the TGA issues the relevant certificate of conformity. As regulations in Australia are similar to those included in the EU directives for medical devices, the registration of products already certified in the EU involves only minor costs and efforts.
The TGA considers MDSAP audit reports when deciding the outcome of a conformity assessment route and the necessity of an audit by TGA.
How TÜV SÜD can help you with the TGA approval process (Australia’s Therapeutic Goods Act)
TÜV SÜD is one of the largest EU Notified Body in the world. Regulatory authorities throughout the world recognise our extensive experience. Within the scope of its registration procedure, the TGA recognises CE marking by an EU Notified Body, like TÜV SÜD. Given this, in most cases, low-risk medical devices can be registered for the Australian market within only three months.
Class-III medical devices with integrated pharmaceutical or biological components do not benefit from CE-marking. Their registrations frequently take up to one year or longer as they require a time-consuming Level 2 Application Audit. However, certified by TÜV SÜD, manufacturers often succeed in the registration process. TÜV SÜD is recognised as an auditing organisation under the MDSAP. Participation in the MDSAP generally results in efficient approval procedures. Manufacturers of medical devices who want to place their products on the Australian markets benefit from efficient registration thanks to TÜV SÜD.
Class-III medical devices with integrated pharmaceutical or biological components do not benefit from CE-marking. Their registrations frequently take up to one year or longer as they require a time-consuming Level 2 Application Audit. However, certified by TÜV SÜD, manufacturers often succeed in the registration process. TÜV SÜD is recognised as an auditing organisation under the MDSAP. Participation in the MDSAP generally results in efficient approval procedures. Manufacturers of medical devices who want to place their products on the Australian markets benefit from efficient registration thanks to TÜV SÜD.
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