The Therapeutic Goods Administration (TGA) has launched a consultation seeking feedback from stakeholders on proposed changes to the classification and definitions of in vitro diagnostic (IVD) medical devices. This initiative aims to align Australian classification rules more closely with the European In Vitro Diagnostic Regulation (IVDR) (Regulation 2017/746) where appropriate.
Key Proposed Changes
- Risk-Based Classification: Ensuring IVDs are classified in proportion to their health risk, technology, and intended use.
- Terminology Updates: Adopting selected EU classification terms to improve clarity and account for new and emerging technologies.
- Definitional Clarity: Providing precise definitions for IVD-related terms that are currently undefined in Australian regulations.
This consultation does not include Rule 1.4 (self-tests), which will be addressed in a separate consultation.
How to Get Involved
The consultation is open for public comment from March 12, 2025, to May 8, 2025. Stakeholders can review the consultation paper and submit their feedback via an online survey during this period. For more details, access the consultation paper here or contact the TGA at IVDs@tga.gov.au.
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