Australia Regulatory Environment for Medical Devices

There are immense opportunities in Australia for marketing and sales of Therapeutic Products (namely medical devices and their accessories).  Since the sign off of the Mutual Recognition Agreement (MRA) with Europe and the acceptance of the CE Marking for a large proportion of Medical Devices, the importation of products into Australia has being much easier. It derives from the fact that the Therapeutic Goods Administration (TGA) reaching a higher level of confidence with a larger majority of Notified Bodies from the European Market servicing manufacturers around the globe.

Furthermore, the fact that the TGA is now accepting the MRA certificate from a selected number of Notified Bodies and for a defined number of products as the mean to fast track applications through the assessment and approval process makes the process easier and more transparent.

Australia’s involvement in various global and Asia Pacific initiatives such as the Global Harmonization Task Force has truly placed the country on the Global regulatory map. The most recent changes occurred in 2010 by Catherine King - Parliamentary Secretary for Health and Ageing- , on the need to have a greater transparency to improve public confidence on the administration, which will further enhance Australia’s position on the global map.

Such major initiative is crucial to a government lead Health Technology Assessment review. Along with the recommended improvements to the way new health technologies, procedures and services are assessed for public and private funding in Australia. The response from TGA for the associated recommendations can be summarized with the following highlights:

• The reclassification of joint replacement implants to Class III (see EU MDD Classification rules)
• The consideration of approving third party assessment bodies to certify manufacturers in Australia to local requirements;
• Amending the manner a kind of Medical Device is included on the Australian Register of Therapeutic Goods (for reference, see device registration in Italy, Portugal, France, Greece & Latvia);
• Improving the manner products are identified by the TGA and
• Improving the manner information on products is publically made available

The Medical Industry is also facing an increased strictness of regulatory assessment on higher risk Medical Devices, such as:

• An increased assessment of post market information (such as for products that are already approved)
• Associated complaints
• Re-substantiation of product claims that were originally submitted during the original product assessment process.

As a consequence of these implementation measures, undoubtedly more pressure will be put on the Industry to ensure not only manufacturing consistency and clinical review of information but as importantly, customer feedback assessment and the use of associated information to update internal documentation.

Although, there will be a perceived expectation of an increase in short term costs,  the end of the tunnel certainly looks like a win -  win result for both the consumers and the Industry.

Resource problems - like in all businesses - remain a major issue but the opportunities in commissioning the right services with long term experience in regulatory submissions, the exposure for some of the more experienced consultants to various industry cultures and practices will definitely provide the certainty of product approvals.

RQSolutions, Obelis’ international office for Australia, can help you with the entire process of registration of your Medical Devices and support you in placing your products on the market.
Its up-to-date Regulatory Information System will show you who’s who in Medical Devices and Medicines in Australia. The use of ISO 13485 forms the back bone of its operation in particular areas of continuous improvement at a most competitive price.

For more information on Australian regulation or to contact Obelis International Office in Australia, please visit our Obelis International Offices (O.I.O.) page.

Last updated Mar 12, 2012

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