Medical Devices; Biological evaluation of medical devices (ICS 11.100.20)

Draft of Regulations on Good Clinical Practice for Medical Devices (15 page(s), in English; 19 page(s), in Chinese)

According to the design, conduct, recording, and reporting of clinical investigations, the regulation is intended to develop a complete management mechanism for clinical investigations on medical devices, to protect the rights, safety, and well-being of subjects and to ensure that the conduction of clinical investigations conforms to ethical and scientific principles.