(Xinhua News Agency) (Reporter Xu Jianhua) On July 3rd, the National Drug Administration released an announcement regarding measures to optimize the supervision throughout the product life cycle and support the innovation of high-end medical devices. The announcement proposed a series of measures in 10 aspects, including optimizing the special approval procedures and improving the classification and naming principles.

The announcement states that medical robots, high-end medical imaging equipment, artificial intelligence medical devices, and new biological material medical devices (collectively referred to as "high-end medical devices") are key areas that shape the new quality productivity of medical devices. In order to implement the requirements of the "Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote High-Quality Development of the Pharmaceutical Industry", improve the review and approval mechanism, strengthen full life-cycle supervision, fully support major innovations in high-end medical devices, promote the application of more new technologies, new materials, new processes and new methods in the medical and health field, better meet the health needs of the people, and enhance China's international competitiveness in high-end medical devices, the National Medical Products Administration has proposed 10 support measures, including optimizing special approval procedures, improving classification and naming principles, continuously improving the standard system, further clarifying registration review requirements, establishing communication and guidance mechanisms and expert consultation mechanisms, detailing post-market supervision requirements, strengthening post-market quality safety monitoring, closely following industry development, promoting regulatory scientific research, and promoting global regulatory coordination. 

In terms of optimizing special approval procedures, support the accelerated market launch of high-end medical devices covered in the high-quality development action plans and other industrial policies at the national level. Strengthen the registration guidance for "challenge-based" products in artificial intelligence and biomaterials, and cooperate with relevant departments to introduce support policies for medical device products based on brain-computer interface technology. To continuously improve the standard system, relevant standards such as those for medical exoskeleton robots and radioactive nuclide imaging equipment will be released more quickly. At the same time, accelerate the revision and formulation of basic, general standards and method standards in areas such as medical robots, artificial intelligence medical devices, and high-end medical imaging equipment, and actively establish a medical robot and artificial intelligence medical device standardization technical organization. Strengthen the standardization research on new types of biomaterials such as medical materials for additive manufacturing, flexible electrodes for brain-computer interfaces, and genetically engineered synthetic biological materials. Conduct research on standard data sets for artificial intelligence medical devices. According to the development and regulatory needs of the industry, promote the establishment of urgently needed standards for high-end medical devices through a fast-track procedure. 

In terms of strengthening post-market quality and safety monitoring, we have refined the types of adverse events for high-end medical imaging equipment and artificial intelligence medical devices, and drafted corresponding reporting scope norms to enhance the quality of adverse event reports. We have continuously promoted the proactive monitoring projects of the Global Harmonization of Post-Market Surveillance (GHWP), starting with high-risk cardiovascular implantable medical devices, to explore the basic framework and database construction methods for post-market proactive monitoring of medical devices, and guide registrants to utilize new tools and methods for medical device alerts to conduct signal mining and utilization of adverse event monitoring data. 

At the same time, in terms of improving classification and naming principles, formulate classification guidelines for medical robots such as surgical robots and rehabilitation robots, and establish an expert consensus on the naming of medical robots. In terms of further clarifying registration review requirements, study and formulate technical guidance principles or review points for related technologies in the field of multi-disease types and large-scale models of artificial intelligence; simplify the requirements for changing registration of artificial intelligence medical device products where the core algorithm remains unchanged but the algorithm performance is optimized; explore and improve the requirements for conducting performance evaluations of artificial intelligence medical devices using assessment databases; for the same artificial intelligence software functions registered on different platforms, if it can be proved that the platforms are equivalent, the review requirements will be simplified. 

In terms of establishing a sound communication and guidance mechanism as well as an expert consultation mechanism, the announcement states that it will further improve the expert database for the review of high-end medical devices, increase the number of experts in relevant active equipment, medical materials, clinical aspects, etc. of high-end medical devices, and enrich the professional directions and research directions of the expert database. In terms of detailing the post-market supervision requirements, it will accelerate the formulation of quality management system inspection points for innovative products such as carbon ion/proton therapy systems, animal-derived artificial heart valves, metal additive manufacturing bone implants, polyetheretherketone suture anchors, etc., as well as high-end products such as medical surgical robots, artificial intelligence medical devices, and recombinant collagen. 

Furthermore, in terms of closely monitoring the development of the industry, a research working group for the development of high-end medical devices has been established. Every year, a report on scientific regulation and industry development of high-end medical devices is organized and compiled. Information on the current state and trends of the industry is studied and released, and suggestions for promoting high-quality industrial development are proposed. In terms of promoting regulatory scientific research, the roles of the artificial intelligence medical device innovation cooperation platform, the biomaterials innovation cooperation platform, and the high-end medical equipment innovation cooperation platform have been fully utilized. The latest research progress in advanced high-end medical devices and the latest developments in science and technology are actively tracked, and new tools, new standards, and new methods are developed at a faster pace. In terms of promoting global regulatory coordination, active participation in the formulation of international standards has been carried out, the conversion and application of international standards have been accelerated, support has been provided for high-end medical device enterprises to go global, policies related to the export and sales certificates of medical devices have been improved, and the scope of issuing export and sales certificates has been expanded.