TGA MDIR SOP + Exemption Worksheet — Australia

Process Package — Vigilance Reporting Australia (TGA)

Complete framework for Australian medical device incident reporting. Covers Medical Device Incident Report (MDIR) under TG (MD) Regulations 2002, the Australia-specific exemption mechanism (events that meet specific criteria can be aggregated in Annual Reports rather than reported individually), and the PRAC (Procedure for Recalls, Product Alerts and Product Corrections) framework effective 5 March 2025.

What’s included:

• SOP-VIG-AU Vigilance Reporting Australia — full procedure: MDIR reportability assessment, exemption framework (5 standard exemption categories), MDIR submission via TGA TBS portal, timelines (10/30 days), PRAC market actions (Recall RC / Product Alert PA / Product Correction PC), Annual Reports for Sponsors.
• F-VIG-AU.1 Australian MDIR + Exemption Justification Worksheet (Word) — assessment of all reportability questions, evaluation against the 5 exemption categories, documented justification (if exemption is later challenged, this worksheet is the evidence), PRAC market action assessment, peer review.

Why this package: The Australian exemption mechanism is unique and powerful when applied correctly — it can dramatically reduce individual MDIR submissions for known foreseeable events. But TGA reviews exemption claims during inspections; an exemption that is later overturned leads to enforcement. This package documents exemption rationale defensibly.

Format: Microsoft Word
Updated: May 2026 — reflects PRAC effective 5 March 2025
Delivery: Instant download after purchase