Response 692859321

Back to Response listing

Introduction

What is your organisation?

Organisation
Medical Technology Association of Australia (MTAA)

Are you responding on behalf of an organisation, or as an individual?

Please select one item
On behalf of an organisation
On behalf of a health professional
As a consumer/individual
Other

Do you give the TGA as part of the Department of Health and Aged Care permission for your submission to be published? Please note unless otherwise indicated, all submissions may be published on the TGA website or the Consultation Hub. If submissions are published, personal information identifying specific individuals will be removed prior to publication.

Please select one item
(Required)
Yes
No

Risk of certain materials

1. What is the level of risk (potential harm to a person) of medical devices containing Xanthan gum, Gellan gum, Cellulose, Fish oil, Chitosan, or Alginate? Does the level of risk (low/medium/high) depend on how and where the material is used?

Minimal risk and does not depend on how or where the material is used.

2. Should Xanthan gum, Gellan gum, Cellulose, Fish oil, Chitosan, and Alginate be excluded from classification rule 5.5 on account of their lower risk? If the exclusion from classification rule 5.5 resulted in a lower classification of the device, are there any safety concerns in relation to the material or the device? Provide your rationale.

Yes the above should be removed from classification rule 5.5.
No safety concerns identified should the exclusion result in a lower classification.

3. Are the below materials still considered low risk and should they continue to be excluded from classification rule 5.5?

Yes, these materials are still deemed as low risk
Yes, they should continue to be excluded from TGA classification rule 5.5

4. Are there other materials of animal, microbial or recombinant origin whereby exclusion from classification rule 5.5 should be considered on account of its low risk in medical devices and would a lower classification rule be suitable to ensure the safety of the material and medical device? Provide your rationale.

Animal charcoal - Animal charcoal is prepared by carbonization of animal tissues such as bones using a temperature ≥800°C. Irrespective of the geographical origin and the nature of the tissue, animal charcoal prepared under these conditions would be considered as an acceptable TSE risk.

Microbial and recombinant materials

5. Do you have any comments or concerns on the risks of devices containing microbial or recombinant tissues, cells, or other substances in general, and how the TGA regulates these products, considering how these products are regulated in other jurisdictions? If so, please provide further information.

MTAA welcomes TGA taking the initiative to consider the risk of these devices and how they are regulated in Australia compared to other jurisdictions.

Before the repeal of Regulation 4.1, these devices were subject to the highest level of scrutiny with a mandatory TGA Conformity Assessment required. With the repeal of Regulation 4.1, while devices containing microbial or recombinant tissue cells are no longer subject to the TGA Conformity Assessment, they are still Class III under Classification Rule 5.5. This is not aligned with the other jurisdictions such as EU. Some examples of devices with different classifications include a surgically invasive catheter for short term use that includes a coating that consists of substances of microbial origin and a Continuous Glucose Monitoring Sensor that contains substances of microbial content. These devices would be Class III in Australia and Class IIa/IIb in EU. Despite having EU certification, as a result of the difference in classification, these devices will be required to undergo a TGA Conformity Assessment which increases regulatory burden for sponsors and delays timely access of these devices for patients. MTAA recommends aligning with EU and removing devices incorporating substances of microbial/ recombinant origin from the Therapeutic Goods (Medical Devices) Regulations 1990, Schedule 2, Part 5, 5.5.

Furthermore, MTAA recommends that the Essential Principle 13.4 (25A), be amended to remove the requirement to have information about any substances of microbial or recombinant origin to be included in the device Instructions for Use (IFU).

These changes would also be in alignment with the regulatory scrutiny that these types of devices are subjected to in other jurisdictions.

6. Do you have any comments or concerns with the proposal to remove substances of microbial and recombinant origin from classification rule 5.5?

No further concerns and MTAA would welcome the removal of substances of microbial and recombinant origin from classification rule 5.5.

Accepting evidence from comparable overseas regulators

7. Do you have any comments or concerns on a proposal to consider alternative conformity assessment evidence for medical devices that contain substances of animal, microbial or recombinant origin, from other comparable regulators beyond the TGA and the EU? If so, please provide further information.

As above, no concerns and strongly support the proposal to leverage evidence from other comparable overseas regulators beyond the TGA and the EU for medical devices that contain substances of animal, microbial or recombinant origin. The benefit of accepting conformity assessment evidence from the broader list of comparable overseas regulators mentioned above is timely access of these devices for Australian patients.