How to Get TGA Australia Medical Device Registration in 2025? скачать в хорошем качестве

How to Get TGA Australia Medical Device Registration in 2025?

This video explains how to register a medical device in Australia with TGA, Australis's health regulatory authority. We outline the complete TGA medical device registration process – from device classification and appointing a local representative, to preparing documentation and submission. Entering the Australian Medical-Device Market? Australia’s A$10.56 billion (US $10.56 b) medical-device sector is growing at 6.3 % CAGR, with 80 % of products imported. Combined with an ageing population (16.8 % over 65) and a healthcare system hungry for innovations that shorten recovery times and cut costs, the opportunity is clear—but so are the regulatory hurdles. Why the TGA Matters? Before a device can be sold, it must be listed in the Australian Register of Therapeutic Goods (ARTG). The Therapeutic Goods Administration (TGA) requires: • Accurate risk-based classification • A complete technical dossier (Aligned to ARGMD) • An Australian Sponsor to submit and maintain the registration • Ongoing post-market surveillance and annual ARTG fees Why Pure Global? ✓ Local Sponsorship—We act as your Australian Sponsor, becoming your in-country regulatory representative. ✓ One-File, Multi-Market—Our single-process approach lets you reuse core documentation across other key markets, accelerating global roll-out. ✓ End-to-End Support—From classification and dossier preparation to post-market vigilance, our experts manage every step so you can stay focused on product and patients. ✓ AI-Powered Efficiency—Proprietary AI tools slash document prep time and keep you ahead of regulatory updates. 🧭Need help with TGA Registration? Contact Pure Global to guide you through your medical device registration in Australia: https://www.pureglobal.com/markets/au... 📧 Email: [email protected] 🌐 Web: https://pureglobal.com We’re here to guide you—wherever you are. 00:00 Australia’s Medical Device Market Overview 00:40 TGA Registration 01:00 How To Classify Your Device? 01:19 Compilation of Technical Dossier 01:29 Australian Sponsor 01:43 Submission Process In ARTG And TGA Assessment 02:09 Post- market Responsibilities 02:50 Approval Timelines, Costs, And Audits 03:18 How Pure Global Supports TGA Registration & Market Entry 03:30 Contact Pure Global This video was created by combining real-world experience with AI. #MedicalDevice #RegulatoryConsulting #Australia