Australia TGA Medical Device Fee Changes: What to Know for 2026 Audits

Podcast: Medical Device Global Market Access · Pure Global

Opublikowano: 2026-10-22

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...