The Therapeutic Goods Administration (TGA) of Australia has officially released its latest Fees and Charges: Summary, effective 1 July 2026. The update covers annual registration fees, application fees, assessment fees and manufacturing-related fees for all categories of therapeutic goods, including prescription medicines, over-the-counter medicines, medical devices, in vitro diagnostic (IVD) products and biological products.
https://www.tga.gov.au/sites/default/files/2026-06/fees-charges-summary-1-july-2026.pdf
Application fees: Initial applications for inclusion of medical devices in the ARTG are charged a basic application fee by product classification.
Annual fees: With the exception of 4 categories of self-use IVD medical devices, all IVD categories follow a unified annual fee standard.
Application fees: A unified application fee applies to all IVD categories applying for inclusion in the ARTG.
Budget update: Registration holders are advised to adjust their annual compliance budgets against the new standards to cover full-lifecycle costs for both marketed products and pending registration projects.
Filing schedule: Projects planned for registration submission or variation applications in the near term can be arranged in alignment with the financial year milestone to control expenditures rationally.
Cost reference: Annual fees for general Class I medical devices remain at a relatively low level. Unified fees across all IVD categories facilitate batch planning for enterprises with multiple product lines.
As the largest medical device market in Latin America with the most sophisticated regulatory system, Brazil is a core target for Chinese medical device enterprises expanding into South America. To celebrate Wiselink’s 6th anniversary, we are launching a limited-time offer: from 18 June to 18 July, a 20% discount applies to consulting service fees for medical device products of all risk classes in the Brazilian market. We welcome inquiries from new and existing clients.
