Upcoming changes in Medical Devices Regulation in Australia

For a medical device to be legally supplied in Australia, it must be included in the Australian Register of Therapeutic Goods (ARTG), which is regulated by the Australian Therapeutic Goods Administration (TGA).

The Australian Therapeutic Goods Administration (TGA) currently recognises CE marking, which means that companies that have already acquired market access in Europe can also easily meet the TGA regulatory requirements.

Review of Medicines and Medical Devices Regulation

In 2014, the Australian government announced the creation of an independent Expert Panel to assess some legislative amendments meant to improve access to therapeutic goods for consumers and remove some of the unnecessary red tape for the industry whilst maintaining the safety of therapeutic goods in Australia. The Panel’s Recommendation Twenty, accepted by the government, states that:

  1. The regulation of medical devices by the Australian National Regulatory Authority (NRA) is, wherever possible, aligned with the European Union framework including in respect of the:
  • Classification of medical devices;
  • Essential Principles/Requirements
  • Adoption of a risk-based approach to variations to medical devices.
  1. Should the Australian NRA seek to apply specific requirements, there must be a clear rationale to do so.

Upcoming changes

The reforms will be progressively rolled out by the TGA over the next 12 to 18 months. Three new pathways by which sponsors can seek TGA approval for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG) will be available:

  1. Conformity assessment completed by a TGA-designated commercial body in Australia (Pathway 1).
  2. Using an overseas marketing approval for the device in circumstances where the device has been:
  • Assessed by a body that has been designated to perform conformity assessments by a comparable overseas designating authority (Pathway 2A);
  • Or approved by a comparable overseas regulator (Pathway 2B).
  1. Expedited approval for new medical devices in certain circumstances (Pathway 3).

For devices which already have a CE marking, companies will still have the possibility to opt for the current most-commonly used approach to access the Australian market (Pathway 2A).

If you wish to learn more about the CE marking process and the EU legislative framework, please do not hesitate to contact us. Obelis Expert Consultants, with nearly 30 years of experience with EU regulatory affairs, will gladly answer your questions.

Martina Quitadamo

in News