Resources

Regulatory Insights & Guidance

Stay informed with expert insights on Australian medical device regulation, TGA updates, and quality system best practices.

Industry Updates

7 August 2026

Regulatory & Market Intelligence Update: Prescribed List Group Definition Review

The Australian Government's formal Prescribed List Reform Program concluded in June 2025, but significant post-reform review activity continues. This update covers the ongoing group definition reviews, industry concerns around reimbursement impacts, and what medical device sponsors and manufacturers should be monitoring.

Regulatory Guidance

6 August 2026

Selling Products in Australia Without TGA Medical Device Approval

If you want to sell a product in Australia but do not yet have TGA medical device approval, what can you lawfully do — and what must you avoid? This guide explains the rules around ARTG inclusion, advertising, therapeutic claims, and the difference between excluded, exempt, and unapproved goods.

Regulatory Guidance

23 June 2026

IVD Regulatory Requirements in Australia: A Comprehensive Overview

In Vitro Diagnostic devices face unique regulatory requirements in Australia. This overview covers classification, conformity assessment, and essential considerations for IVD manufacturers.

Quality Systems

23 June 2026

Post-Market Surveillance: Building an Effective PMS System

Post-market surveillance is not just a regulatory requirement — it is essential for patient safety and product improvement. Learn how to build an effective PMS system.

Industry Updates

23 June 2026

TGA Reforms 2024: What Medical Device Companies Need to Know

Recent TGA regulatory reforms are reshaping the landscape for medical device companies operating in Australia. Here is what you need to prepare for.

Regulatory Guidance

23 June 2026

Understanding the ARTG: A Guide for Medical Device Manufacturers

The Australian Register of Therapeutic Goods (ARTG) is the foundation of medical device regulation in Australia. Learn what manufacturers need to know about ARTG registration.

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