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Demystifying TGA approval:

insights and best practices

About this webinar


As you work on launching your medical device into Australia, you can't afford to ignore the regulatory hurdles standing between your company and marketisation.

The Therapeutic Goods Administration (TGA) is the gatekeeper of Australian medical device quality and integrity.
To unlock market access Down Under, you'll need to embed lasting compliance with their 'essential principles' and build a robust, appropriate and audit-ready document stack.

Join this comprehensive roadmap webinar for an expert-led deep dive into everything you need to make the TGA happy - and to get your medical device through the doors of the $7bn Australian market.



What you'll learn:


  • The complete end-to-end process for getting your medical device approved in Australia, and how to succeed with flying colours

  • Top TGA tips, tactics and most common compliance mistakes

  • How to drive a confident, right-first-time TGA approval process with guidance from a former TGA investigator (now a seasoned medtech consultant!)

Your Presenters

Profile
Sumatha Kondabolu
Senior Quality Specialist II
Qualio
Profile
Lee Walsh
Founder & Principal Consultant
Platypus MedTech Consultants
  • Profile
    Sumatha Kondabolu
    Senior Quality Specialist II
    Qualio
  • Profile
    Lee Walsh
    Founder & Principal Consultant
    Platypus MedTech Consultants