Australia TGA Medical Device Fee Changes: What to Know for 2026 Audits
Medical Device Global Market AccessShow Notes
Australia's Therapeutic Goods Administration (TGA) has updated its guidance on fee reductions for medical device conformity and ARTG application audits. Effective October 1, 2026, these changes introduce a new fee model for design examinations based on Unique Product Identifier (UPI) components, increase certain recertification fees, and raise the minimum fee for subsequent devices in mandatory audits. This episode details what these changes mean for manufacturers and how to prepare your regulatory strategy and budget.
Key Questions: - How is the TGA changing its fee reduction model for design examinations? - What is the new fee reduction percentage for certain recertifications? - By how much is the minimum fee increasing for related devices in a mandatory audit? - When do these new TGA fee structures take effect? - What are Unique Product Identifier (UPI) component assessments and how do they impact costs? - Who is most affected by these changes to TGA conformity assessment fees? - What practical steps should manufacturers take to prepare their regulatory budgets? - How can sponsors strategically plan submissions under the new fee rules?
Sources: - https://www.regconnect.medtech.org.au/september-28th-october-2nd-2026/
How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. For the Australian market, we offer local representation, develop efficient regulatory strategies for TGA submissions, and compile technical dossiers using advanced AI. Our team helps you navigate complex requirements like the TGA's updated fee structure to ensure compliant and cost-effective market entry and maintenance. We manage the entire lifecycle, from initial ARTG registration to post-market surveillance, ensuring your continued compliance. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.
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