Consultation - Review of regulatory requirements for medical devices containing materials of animal, microbial or recombinant origin

Closed 28 Jul 2023

Opened 16 Jun 2023

Contact

Devices Information Line

1800 141 144

devices@tga.gov.au

Feedback updated 9 Feb 2024

We asked

We asked for feedback on potential changes to the regulatory requirements for non-IVD medical devices that contain tissues, cells, or substances of animal, microbial or recombinant origin.

We sought feedback on:

  1. the risk of certain materials of animal, microbial or recombinant origin
  2. removing microbial or recombinant tissues, cells, or other substances from classification rule 5.5, Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)
  3. accepting evidence from a broader range of comparable overseas regulators for devices that contain substances of animal, microbial or recombinant origin.

You said

We received twenty responses.

Most respondents agreed with excluding certain low-risk animal origin materials from classification rule 5.5 and removing “microbial or recombinant origin substances” in general. They commented that these substances are low risk, and the change would align more closely with international regulatory frameworks. Some respondents pointed out that the Essential Principles of the Regulations already specify the safety requirements for the control of animal, microbial or recombinant origin substances.

There was strong support for accepting conformity assessment evidence from a broader range of comparable overseas regulators. Respondents reported that the current requirements are burdensome and have delayed supply of some devices to Australia despite having approvals from recognized comparable overseas regulators. All respondents stated these changes would reduce regulatory burden and enable Australians to have faster access to safe products.

Several respondents asked that the specific labelling requirement related to microbial or recombinant origin substances also be removed from the Regulations to reduce the burden of maintaining Australian-specific Instructions for Use.

The TGA appreciates all the feedback and thanks all respondents.

We did

We analysed the responses and have considered the feedback to shape regulatory reform and policy that is risk-based and that removes unnecessary regulatory burden.

In December 2023, the Government agreed to

a) remove “microbial or recombinant origin substances” from classification rule 5.5 (clause 5.5, Part 5, Schedule 2 of the Regulations)

b) remove associated labelling requirements under Essential Principle 13.4

c) exclude other certain low-risk animal origin materials from classification rule 5.5

d) provide a two-year transition for existing approved devices

e) accept a broader range of comparable overseas regulators for these devices.

We are preparing regulatory amendments for Government approval for possible commencement in mid-2024.

Published responses

View submitted responses where consent has been given to publish the response.

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.

The TGA periodically reviews requirements for medical devices to ensure they continue to be appropriate. When undertaking such reviews, we have regard to the risks and whether those risks have changed over time, international best regulatory practice, and any emerging issues.

The TGA has received requests to review the risk classification of medical devices that contain certain materials from animal, microbial or recombinant origin.

Currently, under the Australian medical device regulatory framework, the TGA regulates medical devices that contain tissues, cells, or substances of animal, microbial or recombinant origin as Class III (high risk) medical devices under rule 5.5, Schedule 2 – Classification rules for medical devices other than IVD medical devices of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).

In 2002, when the Medical Device Regulations were established, the risks associated with these ingredients were considered high. Taking into account new and existing feedback from previous consultations, this consultation now seeks to review the regulatory requirements for medical devices containing materials of animal, microbial or recombinant origin to determine whether any changes should be made.

Consultation Paper

Consultation on regulatory requirements for medical devices containingmaterials of animal, microbial or recombinant origin

download the PDF.

Why your views matter

We are seeking your views about whether the current classification rule and the corresponding conformity assessment procedures continue to be appropriate given the risk status of such products. We seek your feedback on:

  1. the risk of certain materials of animal, microbial or recombinant origin
  2. microbial and recombinant materials in general
  3. accepting evidence from a broader range of comparable overseas regulators for these medical devices.

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

 

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.

Audiences

  • Consumers
  • Health professionals
  • General public
  • Sponsors
  • Manufacturers
  • Medical Devices & IVDs

Interests

  • Health technology