Development and evolution of medical technology management in China

[...]cases of patients failed to be diagnosed and treated in time which led to seriously medical problems or even caused serious medical accidents due to unreasonable application of medical technology happened frequently (such as the case of Ze-Xi Wei incident, resulted from the abuse of autoimmune cell therapy due to inadequate supervision). To simplify the administrative procedures of medical technology management, the 2015 revised edition of Regulation on the Clinical Application of Medical Technology abolished the former approval process of medical technology in administration, and adopted the dynamic recording mechanism instead. [...]the major responsibility of medical technology management application management was delegated to medical institutions. [...]the revised regulation clearly identified that medical institutions were in major charge of medical technology management, which endowed hospitals with greater responsibilities and stricter requirements. Since the new regulation mentioned the establishment of a post-operational supervision mechanism for the clinical application of medical technology and the change of subjects for second and third class medical technology management, the difficulty of management for medical institutions mainly lied in how to carry out specific supervision on these two classes of technology. [...]the newly revised version introduced the concept of negative list and restrictive list of medical technologies instead of the former three-classes-technology definition. [...]the new regulation made specific requirements on the quality management of medical technology application, the standardization in training and assessment of technical operators, as well as details for public supervision on medical technology, which made further improvement in the whole-rounded-process management system.