China clinical application management is an important part of the modern hospital management system to standardize medical technologies and to ensure medical quality and safety. On April 20, 2022, the National Health Commission (NHC) announced (No.6-2022) the National Restrictive Technology Catalogue (2022 Edition) and Clinical Application Management Specifications (2022 Edition) with immediate effect.
Revision Background
In 2015, access management of medical technology of class III medical devices on clinical application were cancelled, in order to carry out the filing management of medical technology for restrictive clinical applications and to strengthen the post-market supervision.
In 2017, the NHC issued relevant documents to clarify the management specifications and quality control indicators for medical institutions to carry out restrictive medical technology clinical applications.
Ever since the NHC issued the Administrative Measures for the Clinical Application of Medical Technology in 2018, the management specifications and quality control indicators started to fall behind on the current standards, hence the National Restrictive Technology Catalogue (2022 Edition) and Clinical Application Management Specifications (2022 Edition) were issued.
China Clinical Application Management – Revision Details
Catalogue of National Restrictive Technologies
- Five technologies including allogeneic skin grafting, deep tumour hyperthermia and systemic hyperthermia, artificial intelligence-assisted diagnosis, craniofacial surgical correction of craniomaxillofacial deformity, as well as combined radical treatment of oral and maxillofacial tumours were removed from the catalogue.
- Two new national restricted technologies have been added:
- Extracorporeal membrane oxygenation (ECMO)
- Autologous organ transplantation
- After the adjustment, 15 items of restricted technologies listed in this catalogue were reduced to 12 items.
Clarification on Disease Diagnosis and Surgicial Operation Code in correspondance to the National Restrictive Technologies
- Each technology corresponds to the “National Clinical Edition 2.0 of Disease Classification and Code” or the “National Clinical Edition of Surgical Operation Classification Code 3.0”, which would be convenient for health administrative departments at all levels and medical institutions to carry out scientific and accurate management work, and further lays the foundation in order to realize the information management for restricted technologies on clinical application. At the same time, it is clearly stipulated that disease diagnosis and surgery/operation are not included in the code which are not managed as national restricted technologies
Further Improvements on the Clinical Application Management Specifications and Quality Control Indicators for National Restrictive Technologies
- Clinical application management specifications and medical quality control indicators were formulated for the newly added extracorporeal membrane oxygenation (ECMO) technology and autologous organ transplantation technology, and 10 national restricted technology clinical application management specifications and medical quality control indicators were revised. According to the actual situation, the requirements of medical institutions, personnel, technical management and training management have been optimized, and the definition, calculation formula and meaning of relevant quality control indicators have been improved to facilitate the implementation and application of medical institutions.
China Clinical Application Management – Working Requirements
Health administrative departments and medical institutions at all levels and all types should strictly follow the Administrative Measures for the Clinical Application of Medical Technology, adjust their own management policies and strategies in accordance with the newly revised national restricted technology catalogue and its clinical application management specifications and quality control indicators, and strengthen the management of relevant technologies on clinical application. Each provincial-level health administrative department shall organize forces to conduct research and demonstration on the 5 technologies adjusted out of the national restricted technology catalogue this time, and clarify whether they are included in the provincial restricted technology catalogue. All types of medical institutions at all levels should carry out the clinical application of national restricted technologies in accordance with the requirements and specifications, submit data and information on the development of restricted technologies to the national and provincial medical technology clinical application information management platforms on a case-by-case basis. Quality control organizations and industry associations at all levels should provide technical support and guidance for medical institutions to carry out the clinical application and management of relevant technologies according to their own work responsibilities.
By Julie Zhang and Jacky Li. If you would like to learn more about supervision of medical device business operations in China or our registration and CRO services for medical devices, IVDs, pharmaceuticals, cosmetics or other products, please contact Cisema.
