澳大利亚ARTG：赞助人与TGA费用

What is the ARTG, and who needs it? It is Australia's public register of therapeutic goods. Most medical devices must be included before supply. And on July 1, fees went up. It starts with a sponsor. An overseas manufacturer needs an Australian sponsor, who applies through TGA Business Services. Unless the device is self-certified, TGA must accept the manufacturer evidence first. Then TGA makes a preliminary assessment decision within 20 business days. For 2026–27, a Class III application fee is $1,603. A Class III entry's annual charge is $1,662, and even a basic Class I entry pays $121 a year. Applications selected for audit pay more. One word to get right. Medicines are listed or registered, but in TGA's own words, medical devices are included in the ARTG, not listed or registered. Start with three things. One: appoint an Australian sponsor. Two: get the manufacturer evidence accepted before you apply. Three: budget for the annual charge, applied every July. Get included before you supply. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.