Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media | Therapeutic Goods Administration (TGA)

Closed 29 Apr 2019

Opened 6 Mar 2019

Contact

1800141144

devicereforms@tga.gov.au

Feedback updated 19 Dec 2024

We asked

We asked for feedback on proposed refinements to the classification of medical devices for human cells, tissues and organs storage solutions and IVF media.

The consultation was hosted on the TGA website and was open for feedback from 6 March 2019 - 29 April 2019.

You said

A total of eight (8) submissions were received. The summary of these responses can be found on the TGA website: Submissions received: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media | Therapeutic Goods Administration (TGA).

 

Some responses indicated a misinterpretation of the medical devices framework. In particular, it appeared that some respondents were not clear that the proposed reclassification will only impact products that are already regulated as medical devices and that it is not intended to apply to products that are not currently regulated as medical devices, such as biological products.

We completed further targeted consultation with respondents and relevant peak professional bodies to clarify the potential impact of the proposed changes. Following this consultation, it was identified that there are effectively equivalent rules under our biologicals regulatory framework, so there is no need to reclassify these devices in Australia.

 

We did

The Government agreed to retain the current regulatory framework for these devices. IVF media and storage solutions of human cells, tissues or organs will not be reclassified. We will inform all key stakeholders and peak bodies of this outcome.

Results updated 19 Dec 2024

The TGA thanks respondents who provided a submission in response to the public consultation paper, the submissions and summary were published on the TGA webiste - Submissions received: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media | Therapeutic Goods Administration (TGA)

This consultation invited respodents to provide feedback on a proposal to classify non-invasive medical devices consisting of a substance, or a mixture of substances, intended to be used in vitro in direct contact with human cells, tissues or organs taken from the human body; or with human embryos, before their implantation or administration into the body, as Class III (high-risk). It was also proposed to incorporate a number of clarifying amendments into existing classification rules 2.2 and 2.3 in Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (AU Regulations). The proposed changes would align the Australian classification of these devices with Rule 3 (Annex VIII, Chapter III) of the EU Regulation on medical devices 2017/745 (EU Regulation).

The responses to the proposal were mixed and indicate that further engagement with stakeholders about the medical devices regulatory framework is required.

The TGA undertook further targeted engagement with respondents to clarify the potential impact of the proposed changes and further develop the proposed regulatory amendments.

 

 

Overview

The Australian Government endorsed a significant program of reform to further strengthen the regulation of medicines and medical devices in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates these products, and is responsible for implementing the Government's reforms.

Medical devices are regulated in Australia having regard to the risks (to the individual or public health) considered in the context of the device’s intended use. The TGA periodically reviews classification rules for medical devices to ensure they continue to be appropriate. When undertaking such reviews, the TGA has regard among other things, to the international best regulatory practice and any emerging issues.

The EU Regulation on medical devices (2017/745)- external site (EU MD Regulation) introduced several amendments to the classification rules effectively reclassifying some categories of medical devices to higher risk classes.

 

Why your views matter

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. While the new classification rule in the EU more appropriately reflects the intended use and the risk of medical devices, this paper considers the extent to which a similar approach will be appropriate in the Australian regulatory context, to further our aim of enhancing the smooth functioning of the medical devices market while also achieving high standards of quality, safety and performance.

Audiences

  • Industry
  • Sponsors
  • Manufacturers
  • Medical Devices & IVDs

Interests

  • Hospitals
  • Health technology
  • Regulatory policy
  • Women's health
  • Organ and tissue donation