Using Overseas Approvals for Medical Devices to Enter the Australian Market

In May 2017, the TGA issued a public consultation to seek feedback on the proposed use of marketing approval by comparable overseas regulators for devices manufactured overseas, to support inclusion in the Australian Register of Therapeutic Goods (ARTG). As a result, from October 2018 industry has seen a huge shift in how TGA review our medical device applications.

Why the change?

In 2014, an Expert Panel (Expert Panel Review of Medicines and Medical Devices Regulation) released 2 reports, consisting of 58 recommendations, that assessed the regulatory framework for medicines and medical devices in Australia. Recommendation 15 called for an additional pathway to allow this utilisation of overseas marketing approvals, whereby the Conformity Assessment on the product had been undertaken by a body that has been appropriately designated by a comparable overseas Designating Authority and has been approved by a comparable overseas National Regulatory Authority (NRA).

What does this mean?

In a nutshell, the TGA is allowing evidence from product approvals by comparable overseas regulators, to be used to support applications for inclusion in our ARTG. These comparable overseas regulators have been assessed by TGA using set criteria, including a similar regulatory framework, IMDRF (International Medical Device Regulators Forum) membership, expertise of the overseas regulator and communication and cooperation seen in the past. As a result, the following overseas regulatory bodies have been accepted (for some types of medical devices):

European Notified Bodies, under the MDD/IVDD and new EU MDR/IVDR
Japan, Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA)
Health Canada
United States Food and Drug Administration (FDA)
Medical Device Single Audit Program (MDSAP) auditing organisations
Health Sciences Authority of Singapore (added September 2022!)

Why is this so important for industry?

The TGA has long accepted certification from European notified bodies as evidence of compliance with the conformity assessment procedures, as stipulated in our legislation (Therapeutic Goods Act 1989, Part 4-3, and Therapeutic Goods (Medical Devices) Regulations 2002, Part 3). However, with the introduction of these additional bodies, industry now has additional options when selecting supporting evidence. If, for example, a medical device is being launched in the US before being launched in Europe, an Australian Sponsor may now be able to submit their application for inclusion once the US FDA evidence is available.

With the ever-increasing delays with European MDR certification by Notified Bodies, Australian Sponsors can now choose an alternate overseas regulatory body approval and effectively by-pass the need to wait or even rely on European MDR certification. Ultimately, this will help bring new technology to the Australian market, faster.