Australia Therapeutic Goods (Medical Devices) Regulations 2002 sch1-14: Essential principle 14: hold clinical evidence suited to the device's use and class that demonstrates compliance with the applicable essential principles

What does sch1-14 require?

Every medical device needs clinical evidence, proportionate to its use and classification, showing it meets the essential principles that apply to it. The evidence is produced through the clinical evaluation procedures in Schedule 3 Part 8, which regulation 3.11 applies to almost all devices, including custom-made devices, in addition to the class-based procedures. TGA's clinical evidence guidelines describe the expected depth by device type, from literature-based evaluations for well-established low-risk devices to clinical investigations for novel high-risk ones.