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Australia Regulatory Update

(Published October 2010)

We are writing to let you know about modifications to TGA medical device applications, TGA's public regulatory consultation, and IVD guidance.

Changes to TGA Medical Device Applications

Three additional questions that have been added to the medical device application for inclusions.1 These questions are designed to give applicants the opportunity to notify relevant Health Technology Assessment (HTA) authorities of their intent to apply for HTA reimbursement.

The questions are as follows:

  • Will you be applying for listing of this product, or procedure in the Medicare Benefit Schedule (MBS)?
  • Will you be applying for listing of this product on the Prosthesis List?
  • Will you be applying for listing of this product on the Co-dependent or hybrid technology application list?

In the future when Emergo, acting as Australian Sponsor, submits an application for ARTG listing we will address these questions with our clients.

TGA Solicits Public Comment on Proposed Changes

On November 2, 2010, the TGA released a discussion paper, Reforms in the Medical Devices Regulatory Framework,2 for public comment on proposed reforms of the Australian regulatory system based on recommendations from the HTA Review.

The HTA Report was released (Feb 27) with recommendations for reforms to the current system designed to improve health care for Australian population, reduce regulatory burdens on industry, and allow timely access to emerging technologies.3,4 The TGA proposed changes are designed to comply with the HTA Review recommendations.

Among several important proposed changes that would affect the medical device industry are:

  • Proposal 2B proposes requiring a TGA conformity assessment for all of the highest risk (Class III/AIMD) implantable devices, and selecting lower risk (Class IIb) devices for auditing.
  • Proposal 3 proposes requiring that all devices and model variants be listed separately on the ARTG. Under this proposal, sponsors would be required to itemize devices and models that are included under a single ARTG entry, identify different models in application forms, and submit an application (with assessment for some devices) for newly introduced models. This will inevitably result in increased costs (to manufacturers) for pre-market assessment. Additionally, the TGA proposes to add sponsor contact information and ARTG numbers to labels and other consumer information associated with the device to allow better identification of the device.
  • Proposal 4 proposes that the TGA increase the amount of information published on the ARTG to improve transparency and accountability of the TGA decision-making process. The scope of the additional data that will be published has yet to be defined, but indications are that it may reflect, to some extent, the type of information published by the FDA (as they use the FDA as an example in their proposal).

Anyone wishing to participate in the future direction of the Australian Regulatory system is encouraged to submit their input. The public comment period will end December 17, 2010. Instructions for submitting comments by mail or email can be found on the TGA website at: http://www.tga.gov.au/newsroom/consult-devices-reforms-101130.htm

IVD Guidance Documents Now Available from TGA

Emergo Group previously reported that the TGA would regulate IVDs in July 2010. With IVD regulations now fully implemented, the TGA has rolled out their first guidance documents. These will be valuable resources for manufacturers to determine conformance requirements. The documents can be accessed through the TGA website at: http://www.tga.gov.au/industry/ivd-guidance.htm


Best regards,



Evangeline Loh, PhD RAC
EMERGO GROUP | Vice President of Regulatory Affairs

1 http://www.tga.gov.au/industry/devices-notice-ebs-changes-101102.htm
2 http://www.tga.gov.au/pdf/consult/consult-devices-reforms-101130.pdf
3 www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr10-nr-nr036.htm
4 www.health.gov.au/internet/main/publishing.nsf/Content/00E847C9D69395B9CA25768F007F589A/$File/hta-review-report.pdf