Australia: Australia's medical devices regulatory framework is set for change, TGA consultations underway

Industry Focus: Life Sciences & Healthcare

What you need to know

  • Following the release of the Federal Government's response to the Expert Review of Medicines and Medical Devices Regulation, the Therapeutic Goods Administration (TGA) has begun its consultation on the reforms to Australia's framework for medical device registration.
  • The changes to the regulatory regime will see current pathways for medical device registration remain, and three new pathways will also be added.
  • Those who want to have a say in shaping the regulatory framework can participate in the TGA's consultation process, which will run between now and March 2017.

It has now been two months since the Federal Government released its response to the Expert Review of Medicines and Medical Devices Regulation, also known as the Sansom Review. The Sansom Review was tasked with reviewing Australia's medicines and medical devices regulatory framework and processes to identify opportunities for improvement.

With the Federal Government having supported most of the recommendations emerging from the Sansom Review, the Therapeutic Goods Administration's (TGA's) consultation process on the implementation of the Government's response is now getting underway.

Here is a quick recap of current regulations governing the registration of medical devices in Australia, the proposed reforms and issues for implementation.

What is the current regulatory framework for medical device registration?

At the moment, there are two pathways by which a medical device may be included in the Australian Register of Therapeutic Goods (ARTG). Medical devices are registered on the basis of conformity assessment certificates obtained by manufacturers in the following ways:

Pathway One Pathway Two
The TGA undertakes conformity assessment and issues the certificate.

An EU notified body undertakes the assessment and issues a device with a CE mark (which indicates that the device meets all EU requirements), and the TGA uses this assessment to determine whether the device should be included on the ARTG.

The TGA conducts application audits to mitigate the risk of poor quality conformity assessments conducted by some EU notified bodies.

What are the main changes?

The current pathways for registration will continue and there will be three new pathways (marked in bold below):

Pathway One Pathway Two Pathway Three

Pathway One will involve conformity assessment occurring within Australia by either:

  1. The TGA
  2. or

  3. A commercial body (such as an Australian affiliate of a European notified body, or an independent organisation) designated by the TGA to undertake conformity assessments of medical devices for the Australian market (and the TGA will not conduct application audits for devices certified by these bodies).

Pathway Two will involve utilising approvals in overseas markets in circumstances where:

  1. The TGA accepts conformity assessment undertaken by an EU notified body and determines whether a device should be included in the ARTG (and it is expected that with time, as confidence in EU notified bodies grows, fewer application audits by the TGA will be required)
  2. or

  3. The device has been approved by a comparable overseas regulator.

Pathway Three will involve expedited approval of 'novel' medical devices.

Pathway Three will be available to products which demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions, and a significant advance over those products already included in the ARTG.

What needs to happen for the changes to be implemented?

A number of measures will need to be taken to give effect to these reforms. These include:

  • Legal and administrative arrangements to support the designation by the TGA of bodies to undertake conformity assessments of medical devices
  • In consultation with healthcare consumers, health professionals and industry, criteria and standards will need to be developed:
    • to designate suitably qualified bodies within Australia to undertake conformity assessments, including standards in areas of technical and clinical competence and governance (including management of conflict of interest) (Pathway 1B)
    • for identifying comparable overseas regulators (Pathway 2B)
    • to determine which devices will be accepted into expedited review (Pathway 3).

When will the changes come into effect?

The TGA will roll out these reforms progressively over the next 18 – 24 months.

What recommended reforms were not accepted by Government?

The Expert Panel Review recommended that a registry should be established to capture information about patients and procedures involving all high-risk implantable devices. However, the Government deferred consideration of this recommendation and determined that further consultation was needed to assess how such registries could be managed and funded in the future, the risks and benefits of establishing registries, and appropriate mechanisms to enable access to data.

What's next?

These will be significant reforms which should align the Australian regulation of medical devices with international developments. More pathways to registration should reduce the burden and cost for industry and make new medical devices available to patients more quickly.

The TGA will now need to flesh out the detail of the new pathways. Between now and March 2017 the TGA will run consultations on:

  • the designation of Australian conformity assessment bodies for medical devices
  • accelerated assessment of medical devices
  • use of overseas regulatory approvals for medical devices and criteria for identifying comparable overseas designating authorities and regulators.

These consultations present an important opportunity for industry to become involved in shaping the regulatory framework for the future.

The first two consultation papers have now been released for comment by the TGA, and comments close on 11 January 2017. Further information about the TGA's consultation process is available at:

This article is intended to provide commentary and general information. It should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this article. Authors listed may not be admitted in all states and territories

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