On March 6, 2025, the Therapeutic Goods Administration (TGA) released updated guidance detailing significant regulatory changes for medical devices incorporating medicinal, microbial, recombinant, or animal-origin substances. These changes, effective from July 1, 2024, aim to streamline regulatory processes, align with international standards, and ensure the continued safety and efficacy of medical devices in Australia.
Purpose of the Guidance
The updated guidance serves to clarify the new regulatory requirements, assisting sponsors and manufacturers in understanding:
- Revisions to classification rules
- Updated conformity assessment procedures
- Transition arrangements for existing devices
Background
In June 2023, the TGA conducted a public consultation to gather feedback on proposed regulatory changes for non-IVD medical devices containing substances of animal, microbial, or recombinant origin. The consultation revealed broad support for the proposals, leading to amendments on June 14, 2024. These amendments, effective July 1, 2024, include:
- Exclusion of certain substances from classification rule 5.5
- Modification of labelling requirements
- Recognition of a broader range of overseas regulatory approvals
Changes to Classification Rule 5.5
Effective July 1, 2024, classification rule 5.5 has been revised to apply specifically to devices containing non-viable animal tissues or cells, excluding:
- Tissues, cells, or substances of microbial or recombinant origin.
- Tissues or cells from hair or wool, or sintered hydroxyapatite, or tallow derivatives.
- Materials produced by animals that are not animal tissues or cells or their derivatives (such as milk, honey, beeswax, or silk).
- A combination of the above.
Devices intended solely for contact with intact skin are also excluded. As a result, some devices previously classified as Class III may be reclassified.
Changes to Labelling Requirements
Manufacturers must update Instructions for Use (IFU) to include information on non-viable animal tissues or cells, as per the revised rule 5.5. For substances no longer covered by rule 5.5, information is required only if relevant to the device's safe use. Additionally, devices containing substances scheduled in the Poisons Standard must comply with associated labelling requirements.
Compliance with Essential Principle 8.2
Manufacturers must implement risk management and control measures for devices containing animal, microbial, or recombinant substances. Compliance can be demonstrated through adherence to standards such as ISO 22442 or the European Pharmacopoeia.
Critical Supplier Changes
The TGA will no longer list suppliers of microbial or recombinant origin materials on conformity assessment certificates. Manufacturers are responsible for managing risks associated with supplier changes and maintaining updated documentation.
Changes for 'Specified Medical Devices'
The term "specified medical devices" has been removed from the 2018 Determination. Devices containing medicinal, microbial, recombinant, or animal-origin substances can now be supported by approvals from a broader range of overseas regulators, including the FDA, Health Canada, PMDA, and HSA. Application audits may be non-mandatory and fee-free, depending on the supporting evidence.
What You Need to Do
- For devices in the ARTG before July 1, 2024:
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Submit a reclassification application by July 1, 2026.
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Continue supply under existing ARTG entry until reclassification is processed.
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- For applications lodged before July 1, 2024:
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Applications will be assessed under previous requirements.
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- For applications lodged after July 1, 2024:
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Must comply with new classification rules and requirements.
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Conclusion
The TGA's updated guidance reflects a commitment to maintaining a risk-based regulatory framework that aligns with international standards. Sponsors and manufacturers should review these changes carefully to ensure compliance and facilitate the continued supply of safe and effective medical devices in Australia.
Navigating the TGA's updated requirements can be complex—but you don't have to do it alone.
Qualtech Consulting Corporation has over 25 years of experience guiding medical device manufacturers through evolving global regulations, including Australia's latest changes for devices with medicinal, microbial, recombinant, or animal-origin substances.
Connect with us today to ensure your devices meet TGA standards—seamlessly and on time.