Overview — All 15 Essential Principles
A complete overview of all 15 Essential Principles that medical devices must meet in Australia, their legislative basis, and how to demonstrate compliance.
EP 1–6 General Principles
Detailed explanation of Essential Principles 1 to 6 — the general safety and performance requirements that apply to all medical devices in Australia.
EP 7–15 Design & Construction
Essential Principles 7 to 15 — the design and construction requirements that apply to specific types of medical devices in Australia.
Checklist & Compliance
How to document Essential Principles compliance for an Australian medical device application, including the TGA checklist template and what the TGA expects to see.