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Australia Therapeutic Goods Act 1989 Readiness Advisory

Score your readiness for free, then turn the results into a plan in a 30-minute strategy call with Ivanka, co-founder of The Art of Service, which has trained 54,000+ professionals across 160+ countries.

38
Controls
9
Domains
–
Mapped Frameworks
Australia (Commonwealth)
Jurisdiction

Why work with Ivanka on Australia Therapeutic Goods Act 1989

Australia's Therapeutic Goods Act 1989, built around medical devices, sponsor obligations and advertising: ARTG inclusion and certification, automatic and imposed conditions, conformity assessment, adverse event, tampering and medicine shortage reporting, recalls, manufacturing licences, advertising controls, counterfeit goods and the offences, civil penalties and executive officer liability that enforce them.

Compliance work stalls when it is treated as a checklist. Ivanka treats Australia Therapeutic Goods Act 1989 as a strategic decision: what matters most for your organisation, what to do first, and what your leadership team needs to understand. For 25 years she has built The Art of Service, whose compliance platform now covers 1,062 frameworks.

The free readiness assessment scores your organisation against the 38 controls across 9 domains of Australia Therapeutic Goods Act 1989. The strategy call turns those scores into priorities.

Relevant credentials

  • Co-founder of The Art of Service, which has trained 54,000+ professionals across 160+ countries
  • MIT Entrepreneurial Masters Program graduate
  • EXIN Expert Panel member

What you get in 30 minutes

Gap Assessment Review

Ivanka reviews your Australia Therapeutic Goods Act 1989 readiness scores with you and agrees which gaps matter most. Specific to your results, not generic advice.

Implementation Roadmap

A clear, prioritised plan for addressing gaps across 9 domains: what you can build on from existing work and what needs new investment.

Cross-Framework Strategy

How Australia Therapeutic Goods Act 1989 fits with the other obligations you already manage, so it strengthens your existing programme instead of running beside it.

Domains covered in Australia Therapeutic Goods Act 1989

01Chapter 4A and Chapter 5: vaping goods, advertising and generic information, counterfeit goods and product tampering
02Chapter 3: sponsor duties for medicines and other therapeutic goods (standards, registration and listing, conditions, adverse effects, recalls, shortages, manufacturing)
03Chapter 4 Part 4-11: offences and civil penalty provisions relating to medical devices
04Chapter 4 Parts 4-1 to 4-4A: medical device interpretation, essential principles, conformity assessment and certificates
05Chapter 4 Parts 4-5 and 4-6: including medical devices in the Register, conditions, suspension and cancellation
06Chapter 4 Parts 4-8 to 4-10: information, mandatory healthcare facility reporting, recall and fees

Plus 3 additional domains. See the full assessment →

This is for you if

  • You need to achieve Australia Therapeutic Goods Act 1989 compliance but don’t know where to start or how to prioritise
  • You’ve been told you’re “compliant” but suspect gaps exist that haven’t been properly assessed
  • You manage compliance for medical device sponsors and manufacturers, pharmaceutical and complementary medicine sponsors, therapeutic goods manufacturers holding tga licences, importers, wholesalers and distributors of therapeutic goods, hospitals and day hospitals, pharmacies and retailers that advertise therapeutic goods, advertising and digital marketing agencies, australian conformity assessment bodies organisations and need expert guidance, not generic templates
  • You want to leverage existing compliance efforts across multiple frameworks rather than starting from scratch
  • You need a strategic plan your leadership team and board will actually understand and support

Start with a free assessment. Then let's talk strategy.

Take the free Australia Therapeutic Goods Act 1989 readiness diagnostic. In 5 minutes you'll have a clear picture of where your gaps are. Then book the strategy call and Ivanka will help you decide how to close them.

Start your free Australia Therapeutic Goods Act 1989 assessment

Free · No login required · Results in 5 minutes

Or go directly to the $149 Report + Strategy Call