TGA Australia Regulations for Medical Devices

Navigate Australia’s TGA regulations, ARTG pathways, and compliance essentials for successful medical device market access.

Functions

Legal/ RegulatoryOperationsQualityR&DSupply Chain
0 Enrolled
1 day

Program Overview

This expert-led program provides a comprehensive understanding of the Therapeutic Goods Administration (TGA) regulatory framework for medical devices in Australia. It covers device classification, conformity assessment, ARTG inclusion, and post-market obligations while highlighting common challenges and compliance pitfalls. With real-world case studies and interactive simulations, participants will gain practical insights into managing submissions, leveraging overseas approvals, and building risk-based strategies for compliance. The course is designed to equip corporate teams with actionable tools to streamline regulatory processes and avoid costly delays in market entry.

Features

  • Understand the TGA regulatory framework and ARTG inclusion requirements.
  • Identify and address common compliance risks and pitfalls in submissions.
  • Learn from real-world case studies of approvals, delays, and recalls.
  • Build a practical roadmap for streamlined Australian market access.

Target audiences

  • Regulatory and Quality Teams
  • R&D Professionals
  • Operations and Compliance Teams
  • Project managers
  • Product specialists

Curriculum

  • 4 Sections
  • 19 Lessons
  • 1 Day
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Instructor

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Huksa

Deep-domain, High Precision L&D - delivered directly by Renowned Industry Practitioners
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8 Students
267 Courses

Offered by Huksa, this L&D program is led by elite industry veterans—CXOs and Functional Heads with 25+ years of deep-domain expertise. You have the flexibility to customize the curriculum, select your preferred expert, and align the program to your organization’s specific objectives. Connect with the Huksa team to explore our array of top-tier trainers available for this course!

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