Summary
The Therapeutic Goods (Medical Devices) Regulations 2002 establish a national scheme requiring pre-market inclusion in the Australian Register of Therapeutic Goods (ARTG), classification-based conformity assessment, compliance with essential principles, labeling rules, and post-market surveillance. The goal is to ensure safety, quality, and performance while aligning with international standards.
Reason
The regulation imposes massive compliance costs, delays market entry, stifles innovation, and reduces competition, especially harming small businesses and rural healthcare providers. Unseen costs include forgone medical advancements, higher device prices, and delayed patient access to life-saving technologies. Safety can be achieved more efficiently through private certification, tort liability, and market signals without the heavy regulatory burden.