The Therapeutic Goods Administration (TGA) has announced proposed changes to the classification system for in-vitro diagnostic (IVD) medical devices in Australia, aiming to better align with the European Union’s Regulation 2017/746. These updates focus on a risk-based classification framework, prioritizing health risks and intended use for device categorization.
Key Changes to IVD Classification
- Cancer Tests: Screening devices for cancer will be reclassified from Class 2 to Class 3 due to the high level of personal health risk involved.
- Preliminary Tests and Monitoring Devices: Exemptions for these devices will be removed, moving them into the Class 3 IVD category.
- Life-Threatening Conditions: The definition will be expanded to include all life-threatening conditions, reclassifying related devices to Class 3.
- Newborn Screening: Devices for newborn screenings will be specifically classified as Class 3 to account for the critical nature of their intended use.
- Control Materials: Adjustments will be made to classify non-assay-specific control materials with assigned values according to their associated IVD device class.
- Software and Instruments: Instruments with independent measuring functions will be reassessed based on purpose and risk. Independent IVD software will be categorized according to its intended use and risk level.
Aims and Benefits
The proposed updates aim to enhance safety, increase transparency, and ensure Australia’s alignment with international standards. By adopting these measures, the TGA seeks to facilitate faster market entry for new products, reduce regulatory burdens for manufacturers, and boost consumer confidence in the safety and reliability of IVD devices in Australia.
Implementation Strategy
Following government approval, these changes will result in legislative amendments and transitional arrangements for manufacturers and sponsors to ensure seamless adaptation to the updated regulations.
This regulatory shift underscores a significant step forward for the Australian medical device landscape, as it adopts a globally-informed approach to safeguarding public health while supporting innovation.
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