Resources

Regulatory Insights & Guidance

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

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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