Review of Recent Regulatory Amendments in Australia: International Harmonization and Reliance

By Megan Gottlieb and Lori White

Background

In recent years, the TGA has enacted several reforms to advance regulatory harmonization or reliance. Manufacturers are able to leverage existing conformity assessment evidence issued by a comparable overseas regulator or assessment body as the Manufacturer Evidence to support an application to add a medical device or IVD to the Australian Register of Therapeutic Goods (ARTG).

Further amendments related to this initiative have been made this year, and the TGA also targets additional amendments to align with the EU regulatory system under the MDR 2017/745 and IVDR 2017/746.

Recognition of comparable overseas regulators and assessment bodies

Historically, the TGA has allowed manufacturers to leverage an EU CE Marking Certificate as the required Manufacturer Evidence for an ARTG application. In 2018, the TGA expanded the accepted forms of evidence to include additional comparable overseas regulators and assessment bodies, e.g., a MDSAP Certificate along with market authorization evidence from the U.S. FDA, Health Canada, or Japan MHLW/PMDA. More recently, in 2022, the TGA added registration with the Singapore Health Sciences Authority (HSA) to the list. The full list of accepted evidence is provided in Schedules 1 and 2 of the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018. In many cases, manufacturers must have Manufacturer Evidence (e.g., MDSAP Certificate) together with evidence of product assessment (e.g., U.S. FDA 510(k) or Health Canada MDL).

Review of changes for specified medical devices and class 4 IVDs

Despite the TGA’s general acceptance of Manufacturer Evidence from comparable overseas regulators and assessment bodies, this was not initially the case for certain class III medical devices (known as “specified medical devices”) and all class 4 IVDs according to regulation 4.1 of the Therapeutic Goods (Medical Devices) Regulations 2002. Until July 2021, the TGA required these high-risk devices to undergo a full conformity assessment review and only accepted a TGA-issued Conformity Assessment Certificate (CAC) as the Manufacturer Evidence.

An amendment passed in July 2021 repealed regulation 4.1, and the TGA began accepting EU CE Marking Certificates as Manufacturer Evidence for these devices. This year, an amendment to the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018, with effect from July 1^st, allows manufacturers to leverage additional forms of Manufacturer Evidence from comparable overseas regulators and assessment bodies for these devices.

Reduction of mandatory application audits

Regulation 5.3(1) of the Therapeutic Goods (Medical Devices) Regulations 2002 establishes the list of devices whose ARTG application will be subject to a mandatory audit by the TGA. The TGA has made various revisions to this list, the latest as part of the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024, which removed certain class IIb devices that were previously included in the list, amongst other changes. Effective July 1^st, the list includes only class III medical devices leveraging a legacy CE Marking Certificate under the former EU MDD or AIMDD that remains valid by virtue of the transitional arrangements of the EU MDR, along with the following IVDs leveraging certain types of Manufacturer Evidence: class 3 and 4 IVDs, class 4 in-house IVDs, and IVDs for self-testing or point of care testing.

Up to July 2021, the IVDs listed in regulation 5.3(1) could only be exempted from the mandatory audit if they were certified under a TGA-issued CAC. The July 2021 amendment also extended the exemption to devices with a CE Marking Certificate issued under the EU IVDR. Under the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024, the exemption was extended to devices with a Canada MDL, U.S. PMA, Japan PMC or PMA, registration in Singapore, or Australia-UK MRA/EC MRA/EFTA MRA certificates. Thus, the IVDs listed in regulation 5.3(1) are only subject to an audit if they leverage one of the remaining non-exempt types of Manufacturer Evidence: a legacy CE Marking Certificate under the former EU IVDD, MDSAP accompanied by a U.S. 510(k) or an ISO 13485 certificate.

Although many devices may be exempted from a mandatory audit as a result of these changes, the TGA may still select any ARTG application for a non-mandatory audit, though no audit fee is incurred.

Additional proposed reforms

This year, the TGA has also made strides towards the following proposed amendments for greater alignment of the Australian regulations with the EU MDR and IVDR:

• The TGA intends to approve UDI regulations by the end of 2024, with voluntary compliance activities to follow in 2025.  
   
• The TGA has proposed changes to align the Australian Essential Principles with the European General Safety and Performance Requirements (GSPR) from the MDR and IVDR.

Concluding remarks

The TGA has been on a significant journey of regulatory reform and improvement. Its goal is to reduce unnecessary burdens on manufacturers while remaining dedicated to ensuring device safety and compliance.

The TGA has increased its recognition of market authorization evidence from comparable overseas regulators and assessment bodies. It also continues to pursue alignment with EU regulations.