Understanding Requirements for Medical Devices Containing Medicinal, Microbial, Recombinant, or Animal Origin Substances
Recombinant, or Animal Origin Substances
Recent regulatory updates for medical devices containing medicinal, microbial, recombinant, or animal origin substances took effect on 1 July 2024. These changes align Australia’s classification framework with international standards while ensuring a risk-based approach to classification and oversight.
This blog provides an overview of the key updates, their impact on medical device sponsors and manufacturers, and steps for ongoing compliance.
Legislation Governing These Changes
These updates impact the following regulatory frameworks:
- Therapeutic Goods (Medical Devices) Regulations 2002
- Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018
- Poisons Standard
- Therapeutic Goods Act 1989
Key Regulatory Changes
1. Amendments to Classification Rule 5.5
From 1 July 2024, classification rule 5.5 has been refined:
- Substances of microbial or recombinant origin are no longer classified under rule 5.5 and may now fall under different classification rules.
- Materials such as milk, honey, beeswax, silk, and tallow derivatives are no longer classified under rule 5.5.
- Devices intended only for intact skin contact are exempt and must follow other applicable classification rules.
Classification Changes:
| Device | Previous Class | New Class |
| Contact lens solution with microbial-derived hyaluronic acid | Class III | Class IIb |
| Intraocular lens containing microbial-derived hyaluronic acid | Class III | Class IIb |
| Wound dressings containing microbial-derived hyaluronic acid | Class III | Class IIa or IIb |
| Devices containing hyaluronic acid of animal origin | Class III | Class III (unchanged) |
2. Labelling Requirements
- Devices containing non-viable animal tissues, cells, or derivatives must include relevant details in the Instructions for Use (IFU) unless they are no longer covered by rule 5.5.
- Devices containing scheduled substances (e.g., collagen, hyaluronic acid, lactic acid) must comply with additional labelling requirements under the Poisons Standard.
3. Compliance with Essential Principle 8.2
Manufacturers must continue to comply with Essential Principle 8.2, ensuring risk management and control for:
- Non-viable tissues, cells, or derivatives of animal origin.
- Tissues, cells, or substances of microbial or recombinant origin.
Compliance can be demonstrated by adhering to ISO 22442: Medical Devices Utilizing Animal Tissues and similar standards.
4. Critical Supplier Oversight
- The TGA no longer considers microbial or recombinant origin substance suppliers as critical suppliers.
- These suppliers are no longer listed on TGA conformity assessment certificates.
- Manufacturers must still evaluate risks associated with supplier changes and update their Quality Management System (QMS) accordingly.
5. Broader Recognition for ‘Specified Medical Devices’
Previously, applications for devices containing medicinal, microbial, recombinant, or animal origin substances were restricted to:
- TGA conformity assessment certification, or
- EU MDR certification.
From 1 July 2024, additional international approvals are accepted, including:
- United States FDA approval
- Health Canada medical device licence
- Japan PMDA approval
- Singapore HSA registration
This change streamlines regulatory approvals and facilitates market entry.
Steps for Compliance
Reclassification of Existing Devices
- Devices that have been reclassified to a lower class must have a reclassification application submitted by 1 July 2026.
- Transition arrangements allow continued supply while reclassification applications are processed.
New Applications Moving Forward
- All new applications must comply with the updated classification framework.
- Sponsors should submit a new application for inclusion in the Australian Register of Therapeutic Goods (ARTG). KD&A is able to assist with this.
Submitting a Reclassification Application
For changes involving new manufacturers or consolidating ARTG entries, a new inclusion application may be required instead.
| Requirement | Deadline |
| Reclassification application for existing ARTG devices | 1 July 2026 |
| Cease supply If no reclassification submitted | 1 July 2026 |
| Last date to supply if application rejected | Upon notification |
KD&A can assist you with submitting a Reclassification Application.
Conclusions
This new guidance published by the TGA supports manufacturers and sponsors navigate the 01 July 2024 changes to the classification of Medical Devices Containing Medicinal, Microbial, Recombinant, or Animal Origin Substances. These changes to the Regulations were implemented to align more closely with international requirements and support smoother market entry for devices supported by overseas evidence of conformity assessment.
Key Takeaways:
- Assess whether your device requires reclassification and apply before 1 July 2026.
- Ensure your labelling and compliance documentation reflect the new requirements.
- Follow updated conformity assessment processes to maintain regulatory compliance.
For more details, visit the official TGA guidance page.
Need expert assistance? Contact KD&A for professional guidance on navigating these regulatory changes.
