Proposed regulatory options for medical devices containing nanomaterials

Closed 9 Apr 2021

Opened 19 Feb 2021

Feedback updated 7 Nov 2022

We asked

The Therapeutic Goods Administration (TGA) published the Consultation: Proposed regulatory options for medical devices containing nanomaterials in February 2021. This paper called for interested stakeholders to present their views on possible options for aligning the Australian medical device regulatory framework with the European Union (ED) framework for medical devices containing nanomaterials. The consultation closed in April 2021.

You said

The TGA received seven submissions from the four medical device industry stakeholders, one medical professional association, one university, and one private individual.

Individual submissions will not be published for this consultation, due to the small number of responses and lack of publication permission from the respondents.

Submissions from the medical devices industry generally agreed that, for practical purposes, Australian medical device regulations should be aligned with European medical device regulations. Submissions received from the medical devices industry noted that this alignment would assist in reducing the regulatory burden and effort required from industry and would speed up patient access to medical devices and nanotechnologies. The medical professional association submission noted that it is presently unclear which definition is best suited for an Australian regulatory framework and sought further explanation as to why the EU definition would be selected for use in Australia.

There was general support from the medical device industry, the medical professional association, and the university for the adoption of Option 2 in the consultation discussion paper - making requirements explicit - which would add definitions and amend the Essential Principles. Submissions from industry and the university suggested that, as well as aligning the Australian medical device regulations with the European medical device regulations, Australia should add definitions to provide clarification of responsibilities for sponsors and manufacturers, greater legal certainty and to ensure a high level of health protection. The submissions also recommended that the Essential Principles in Australian medical device regulations be amended to include nanotechnologies.

It was noted in submissions from the medical device industry, the medical professional association, and the university that there are difficulties with defining and measuring nanomaterials, issues related to particle size, and limited manufacturing data on nanomaterials. Expert opinions were provided in these submissions for risk classifications, safety assessments and the regulation of medical devices with nanomaterials.

Submissions varied on whether new classification rules are needed (as outlined in Option 3 of the consultation paper). Two submissions recommended new classification rules to evaluate nanomaterials and reflect nano-specific issues.

Submissions from the medical device industry did not recommend consideration of the potential to generate nanoparticles through wear or degradation when classifying medical devices or developing new rules for nanomaterials, noting the position of the MedTech Europe special interest group on nanomaterials. The submission from the university noted that abrasive wear of devices may generate nanoparticles and that the related chemical activity of these nanoparticles should be a focus for industry. One submission considered that an additional clause related to the risk of generating nanoparticles from new devices should be included due to the potential of inducing harm to users. Another submission considered it would be helpful to distinguish between nanoparticles not known to be absorbed versus those with absorption potential, and that systemic exposure should be evaluated for each individual case.

Submissions from the medical device industry generally agreed that a staggered approach would be needed for transitional arrangements to align with the European medical device regulations transition times. Recommended transition times varied from a 12-month post European medical device regulations transitional period,(one submission) to a three-year transition period (two submissions).

Submissions from the medical device industry, the medical professional association and the university also noted the need for guidance and training material for clinicians, manufacturers, and sponsors to set standards and to assist in obtaining TGA approval for these medical devices. It was also noted in submissions from the medical professional association and university that continued consultation with stakeholders and updated guidance would be needed for new developments and as understanding of nanomaterials increases over time.

We did

The submissions to the public consultation indicated that Option 2 would provide both clarity and flexibility to a broader range of relevant stakeholders.

To this end, as outlined in the consultation paper, the TGA will:

  • seek amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 to:
    • include proposed definitions of nanomaterials
    • make changes to the Essential Principles to provide further clarity in relation to nanomaterials, in line with European requirements.
  • prepare guidance material to provide clarification about the regulation of medical devices containing nanomaterials


The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms.  We have issued this consultation paper as part of the reform program.

In 2015, the Report of the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR) made 58 recommendations for reform of the regulatory framework for medicines and medical devices in Australia. The Australian Government Response to the Review of Medicines and Medical Devices Regulation was released in September 2016. The Government accepted 56 MMDR recommendations including Recommendation Twenty which provided that the regulation of medical devices, wherever possible and appropriate, align with the European Union (EU) framework including the classification of medical devices.

The EU introduced a new medical device regulatory framework from 2017, which included new requirements around nanomaterials. This paper examines whether the Australian medical device regulatory framework should be aligned to the EU framework for medical devices containing nanomaterials, and how this could occur.

Why your views matter

European regulatory changes on nanomaterials in medical devices has prompted consideration of nanomaterials in the context of the Australian regulatory framework.  The EU Regulation on medical devices (2017/745) (EU MD Regulation) included several changes to:

  • definitions: introduce a ‘nanomaterial’ definition: “particles with one or more external dimensions in the size range 1-100 nm”; and some related definitions (particles, agglomerates, aggregates)
  • essential principles: specify consideration of risks linked to the size of particles, with special attention given to nanomaterials in the essential principles (or equivalent)
  • classification rules: reclassify some categories of medical devices to higher risk classes for “all devices incorporating or consisting of nanomaterials”, based on the degree of potential invasiveness within the body.

In this consultation we are seeking your views on:

  1. Should specific requirements for medical devices containing nanomaterials, be introduced in the Australian MD Regulations?
  2. If so, what option/s should be adopted?:
    1. Option 1 – no change
    2. Option 2 – add definitions and amend essential principles
    3. Options 3 – add new classification rules
  3. What impacts—including any that we may not have anticipated and are therefore unintended—do you anticipate the new definitions, essential principles and/or classification rules may have for yourself and other stakeholders (such as consumers, healthcare professionals, health organisations, industry etc.)?
  4. Are there any further issues and questions we should consider when implementing these changes (including areas that can/should be clarified in our guidance)?
  5. If Option 3 – add new classification rules proceeds, what criteria should be used to decide whether a device has a negligible, low, medium and high potential for internal exposure?  Should the term ‘potential for internal exposure’ be clarified in our guidance or defined in the Australian MD Regulations? If yes, what definition do you propose for the meaning of this term?
  6. Are there any groups of medical devices containing nanomaterial that should be given particular consideration or treatment?
  7. Nanoparticles may be generated as a consequence of the degradation of medical devices not containing nanomaterials or abrasive wear or grinding of a material. Should we clarify whether such devices will be affected by the proposed new rules?
  8. Do you have any comments regarding the transitional arrangements proposed in this paper?

For further background and information, please refer to the consultation paper Proposed regulatory options for medical devices containing nanomaterials, downloadable via a link at the bottom of this page.

We invite you to complete our online survey (click on the link below).

If you prefer, you can make a submission directly to the Department via post or email at the following addresses:

Medical Devices Reform Unit
Medical Devices Branch
Therapeutic Goods Administration
PO Box 100

If you choose to do this, you may download the MSWord version of the consultation paper to use as a template for your response. Please also download and complete a copy of the Cover Sheet. Both are available via links at the bottom of this page.

What happens next

Submissions will be reviewed by the TGA. A summary of responses will be published and all submissions will be placed on this website (unless marked confidential or indicated otherwise in the survey or submission form).

Outcomes from the consultation will be provided to the Government for consideration.


  • Academics
  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Health professionals
  • Health workforce
  • Businesses
  • Health staff
  • HPRG (TGA) Staff
  • Medical Devices & IVDs


  • Health technology