Medical Device Market Approval & Certification

Australia’s Therapeutic Goods Regulations

Be confident of medical device market approval

Be confident of medical device market approval

Regulations similar to EU requirements

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.

Regulatory process

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. However, for expansion onto the fifth continent, medical devices need to complete conformity assessment with a positive result.

The authority responsible for the registration of medical devices in Australia is the Therapeutic Goods Administration in short TGA. The TGA applies an extensive procedure to verify whether applicants meet the conformity requirements of Australia. If the conformity assessment procedure is completed with 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.

As Australia was one of the key players in the development of the Medical Device Single Audit Program (MDSAP) and is one of the partners participating in the program, the TGA also recognises MDSAP audits. In other words, manufacturers participating in the MDSAP who intend to place their devices on the Australian market do not have to undergo a TGA audit. The TGA considers the MDSAP audit reports in its conformity assessment.

Why choose TÜV SÜD

TÜV SÜD is the largest EU Notified Body in the world. We have extensive experience and are therefore recognised by regulatory authorities throughout the world.

Within the scope of its registration procedure, the TGA recognises CE marking by an EU Notified Body, including 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, supported by TÜV SÜD, manufacturers often succeed in speeding up the registration process. TÜV SÜD is recognised as an auditing organisation under the MDSAP. Participation in the MDSAP generally results in more efficient approval procedures. Manufacturers of medical devices who want to place their products on the Australian markets benefit from shorter procedures, faster registration and earlier market launch.


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