Proposed regulatory options for medical devices containing nanomaterials

Overview

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 we are consulting

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
WODEN ACT 2606

devicereforms@tga.gov.au

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.