TGA ARTG SOP + Pathway Selection Template — Australia

Process Package — Marketing Authorization Australia (TGA)

Complete framework for Australian TGA ARTG inclusion. Covers Sponsor designation, classification under TG (MD) Regulations 2002, the five conformity assessment pathways, Essential Principles (Schedule 2), AusUDID (effective 2025), and Annual Reports for ARTG-included devices.

What’s included:

• SOP-REG-AU Marketing Authorization Australia — full procedure: Sponsor designation, classification rules, 5 conformity assessment pathways (TGA-CA, EU CE Mark, MDSAP, Comparable Overseas Regulator, Self-declaration), ARTG inclusion application via TBS, Essential Principles compliance, AusUDID, Annual Reports for sponsors, lifecycle variations, cross-reference to PRAC market actions.
• F-REG-AU.1 Conformity Assessment Pathway Selection (Word) — structured worksheet comparing all 5 pathways with selection rationale, classification rationale, Essential Principles mapping, and approval block.

Why this package: Australia accepts 5 different conformity assessment routes — choosing the right one is a major cost and time decision. This package gives you the framework to compare them objectively (particularly leveraging your existing CE Mark or MDSAP certificate to fast-track ARTG inclusion).

Format: Microsoft Word
Updated: May 2026 — includes AusUDID Regulations 2025
Delivery: Instant download after purchase