FDA in Australia

Understanding the FDA in Australia

While Australia does not have a body called the "FDA" like the United States, its equivalent is the Therapeutic Goods Administration (TGA). The TGA functions as Australia's regulatory authority for therapeutic goods, ensuring public health and safety.

🧪 Therapeutic Goods Oversight
The TGA regulates a wide range of products including medicines, medical devices, blood products, and biologicals. All therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied. This registration process involves evaluating the safety, quality, and performance of products through scientific and clinical evidence.

📦 Medical Device Classification
The TGA classifies medical devices based on risk—ranging from Class I (low risk) to Class III and Active Implantable Medical Devices (high risk). Each classification requires a different level of conformity assessment. This system ensures that higher-risk products undergo stricter review before being approved for market access.

🛡️ Post-Market Surveillance
Regulation doesn’t end with product approval. The fda australia actively monitors products after they are on the market through adverse event reporting, recalls, and compliance reviews. This helps identify issues early and protect public health through swift intervention if needed.

📝 Sponsor Responsibilities

Any business intending to supply therapeutic goods in Australia must be registered as a sponsor. Sponsors are responsible for ensuring ongoing compliance, including updating labeling, reporting adverse effects, and maintaining documentation. They also act as the primary point of contact with the TGA.