Center for Medical Device Evaluation Actively Prepares for the Registration Peak of AI Medical Devices

  • 2019-04-08
Recently, NMPA issued a public notice, notifying that three organizations in charge of technical standardization for medical devices including National AI Medical Devices are intended to be established. The establishment of organization in charge of technical standardization for AI medical devices shows that China will keep improving the standard system for the AI medical device industry and intensify supervision of the industry so as to contribute to more standard of the industry. It also indicates that China is paying much attention to the key field of AI medical devices and supporting the priority development of emerging technologies. Center for Medical Device Evaluation, NMPA ("CMDE-NMPA"), as an important evaluation department of AI medical devices in China, has been paying attention to the development trend of AI medical devices and actively promoting scientific research on the supervision of AI medical devices under the leadership of NMPA.
Solidifying the foundation internally
The AI working team of CMDE-NMPA was established formally to research the scientific supervision of AI medical devices in 2017. The members of the working team come from relevant evaluation departments and innovative device review departments of CMDE-NMPA and medical device registration and test organizations of national drug regulatory authorities, covering all links of post-marketing supervision of AI medical devices.
Industry surveys on various aspects were carried out after the establishment of the AI working team. The first, the team reviewed foreign supervision policies for AI medical devices and product evaluation and approval by searching literature; the second, the team made exchanges with related enterprises, research institutions and medical institutions to fully understand technical characteristics, product features, industry development status and clinical risks and other details concerning AI; the third, the team collected information on AI medical device manufacturers to deeply understand concentration and R&D stages of AI medical device products and types of manufacturers. These surveys laid a solid foundation on subsequent scientific research on AI medical device supervision.
The AI working team combined guidelines and evaluation experience related to medical device software with early surveys to form Evaluation Points of Medical Device Software for Deep Learning and Decision-making (hereinafter referred to as “Evaluation Points”) based on multiple modifications. Evaluation Points focuses on data quality control, generalization ability of algorithm and clinical risks of AI medical devices and specifies the evaluation points of the overall life-cycle of AI medical devices based on medical device software for deep learning and decision-making. It was changed into an exposure draft through discussion, modification and improvement by experts.
Considering that a large number of manufacturers will apply for special review of innovative medical devices of AI medical devices, the AI working team formulated special review points of AI medical device innovation based on Evaluation Points, so as to promote technological innovation.
By use of the international supervision experience and discussion and research, the AI working team thought that the management categories of AI medical devices should be determined based on the expected use, use scenarios and core functions on the condition that medical device data is the process object and AI products applicable to medicine belong to medical devices. At present, experts have formed corresponding suggestions on supervision policies through research and discussion and have formally submitted them to relevant departments of NMPA.
Cooperating with other institutions
CMDE-NMPA has reached an agreement with Medical Artificial Intelligence Branch of Chinese Society of Biomedical Engineering on the basis of early good cooperation with the Society. The two parties will conduct close cooperation on scientific research on AI medical device supervision. The two parties held an Expert Seminar on Evaluation Points in January this year. Nearly 20 technical and clinical experts attended the seminar and put forward valuable suggestions and opinions for the improvement of Evaluation Points.
In recent years, CMDE-NMPA has also cooperated with China Academy of Information and Communications Technology, and has successfully applied for a number of national scientific research projects. On this basis, the two parties will further strengthen the cooperation on scientific research on AI medical device supervision.
Servicing for the industry and developing with the industry
In April 2018, IDx-DR, a kind of software for diabetic retinopathy screening, was approved to hit the market by FDA, which attracted wide attention in the industry. The AI working team released Marketing Profile of American Diabetic Retinopathy Screening Software IDx-DR in the WeChat Official Account of CMDE-NMPA, analyzing the requirements of AI medical device evaluation by US FDA from the perspective of evaluation, guiding manufacturers to correctly understand the evaluation processes of US FDA.
In February this year, CMDE-NMPA published “AI Medical Devices with Deep Learning - Discovering shortcomings after Learning" in China Pharmaceutical News and forwarded it via the WeChat Official Account of CMDE-NMPA. In the article, the development bottlenecks in medical devices with the deep learning technology are analyzed, guiding manufacturers to pay attention to data quality control, generalization ability of algorithm, clinical risks and other aspects of products.
In addition, CMDE-NMPA attended a number of major domestic forums and events related to AI medical devices, where it actively conveyed the ideas of China's AI medical device supervision to the industry, so as to develop along with the industry.
On December 25, 2018, CMDE-NMPA successfully held a public training course for the registration and application of AI medical devices together with China Health-Media Group, Ltd., where the concerns of manufacturers were comprehensively analyzed. Nearly a thousand technicians and managers from enterprises engaging in medical devices, AI, Internet and others around China attended the training course.
CMDE-NMPA will further carry out scientific research on AI medical device supervision, formulate general guidelines for evaluation of AI medical devices and guidelines for evaluation of key products, protect public health and promote technological innovation and contribute to the healthy development of AI medical device industry. CMDE-NMPA has prepared for the coming peak of registration and application of AI medical devices.