Introduction
3. What is your organisation?
Organisation
MTAA
4. Are you a manufacturer/sponsor/consumer/health care professional?
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Manufacturer
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Sponsor
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Health Care professional
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Other
Proposed amendments
5. What are the regulatory implications of the proposed changes to the classification rule?
Can you think of any impacts or issues if Patient Information Leaflets and/or Patient Implant Cards were to be only provided electronically
Although it would seem appropriate to amend the classification rule since products systemically absorbed by the body meet the definition of a medicine under the Act in Australia, there will be a significant regulatory impact from this change.
This proposed change would result in the misalignment of classification with the EU and could result in a product classified as a medical device in the EU and medicine in Australia.
As such, new products and treatments being developed in the EU would not be able to be registered in Australia for the following reasons:
- The regulatory framework and requirements for a medicine compared to a medical device containing a medicinal component are significantly different
- Medical device manufacturers may not have the resources or capability to support a product that is regulated as a medical device in the EU and medicine in Australia
- Overseas manufacturers and suppliers may not find it beneficial to conduct the extra regulatory requirements solely for an Australian market which is quite small in comparison
This will significantly impact new innovations and treatments developed overseas being brought into Australia thereby medically disadvantaging the Australian population.
This proposed change would result in the misalignment of classification with the EU and could result in a product classified as a medical device in the EU and medicine in Australia.
As such, new products and treatments being developed in the EU would not be able to be registered in Australia for the following reasons:
- The regulatory framework and requirements for a medicine compared to a medical device containing a medicinal component are significantly different
- Medical device manufacturers may not have the resources or capability to support a product that is regulated as a medical device in the EU and medicine in Australia
- Overseas manufacturers and suppliers may not find it beneficial to conduct the extra regulatory requirements solely for an Australian market which is quite small in comparison
This will significantly impact new innovations and treatments developed overseas being brought into Australia thereby medically disadvantaging the Australian population.
6. Do you agree that the proposed amendment to the classification rule – to remove references to products that are systemically absorbed – will clarify the regulation of products that are systemically absorbed by the body?
Do you have any other comments/suggestions in relation to how Patient Information Leaflets and Patient Implant Cards are to be supplied?
MTAA does not agree with the proposed amendment.
7. Can you think of any other impacts or issues if the classification rule is amended?
Do you foresee any cost implications as a manufacturer/sponsor/consumer should the proposed change occur?
Just to reiterate, there will be a significant medical disadvantage to the Australian population if they are not able to access medical innovation due to the difference in regulatory pathway for medicines compared to medical devices.
Other questions
8. Do you have any other comments in relation to the above issues?
Do you have any other comments in relation to the above issues around patient information materials?
There is a further question on how TGA interprets the classification rule.
For example in EU - Ultrasound gels are not intended to be absorbed or locally dispersed within the body at the site of action in order to achieve their intended purpose, therefore Class I in EU.
However under TGA’s new classification rule even though the gel is not intended to be absorbed or dispersed, it may still have some very small amount that will get absorbed or dispersed, so may be classified as Class IIa under this new rule.
Can TGA provide further clarification on this example and whether this rule will apply or not depending on if the device is/is not intended to be absorbed?
For example in EU - Ultrasound gels are not intended to be absorbed or locally dispersed within the body at the site of action in order to achieve their intended purpose, therefore Class I in EU.
However under TGA’s new classification rule even though the gel is not intended to be absorbed or dispersed, it may still have some very small amount that will get absorbed or dispersed, so may be classified as Class IIa under this new rule.
Can TGA provide further clarification on this example and whether this rule will apply or not depending on if the device is/is not intended to be absorbed?
Required - Final step - Publishing my response
9. Do you consent to the Department collecting the information requested in Citizen Space about you, including any sensitive information, for the purposes of this consultation?
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12. May we contact you for further information or to seek feedback about how the consultation was undertaken?
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13. By making a submission, I acknowledge that:
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