How to Register a Medical Device with TGA in Australia

This video provides a comprehensive walkthrough of the medical device registration process in Australia, including how to classify your product, prepare technical documentation, appoint an Australian Sponsor, and navigate submission with the Therapeutic Goods Administration (TGA). If you're looking to enter one of Asia-Pacific’s most stable and innovation-driven healthcare markets, this guide offers the regulatory clarity you need to get started.

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Australia’s medical device market is valued at A$10.56 billion (US $10.56 billion) and growing at a steady 6.3% CAGR. With more than 80% of devices imported and nearly 17% of the population over age 65, the country presents strong demand for advanced diagnostic and therapeutic technologies, particularly those that can lower costs or improve care outcomes. But tapping into that opportunity requires a thorough understanding of TGA’s regulatory expectations and submission processes.

Key topics covered in this video include:

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• Australia’s Medical Device Market Overview
  A look at market size, demand drivers, and why Australia is a strategic target for medical device manufacturers.

• TGA Registration
  What it means to be listed on the ARTG and why it’s a prerequisite for legal sale.

• How to Classify Your Device?
  Guidance on using TGA’s risk classification rules to determine your device’s regulatory path.

• Compilation of Technical Dossier
  What documentation you need to prepare for assessment, including QMS and clinical data.

• Australian Sponsor
  The Sponsor’s role in submitting, maintaining, and communicating with the TGA on your behalf.

• Submission Process in ARTG and TGA Assessment
  Step-by-step guidance on how the process works and what to expect.

• Postmarket Responsibilities
  What you need to do after approval to stay compliant.

• Approval Timelines, Costs, and Audits
  Realistic expectations for review timelines, application fees, and audit readiness.

• How Pure Global Supports TGA Registration & Market Entry
  Overview of how Pure Global acts as your Australian Sponsor, manages your submission, and ensures full regulatory alignment.

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Need help with TGA registration?
Pure Global offers end-to-end support for TGA compliance, from classification and technical dossier preparation to sponsor services and post-market surveillance. Our AI-powered tools and expert consultants help you move faster and smarter in one of the world’s most promising medical device markets. Contact us today to learn more Australia TGA registration for medical devices.

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