Recently, the State Drug Administration issued public information, plans to establish the national artificial intelligence (AI) medical devices and other three medical device standardization technology focal point. The establishment of artificial intelligence medical device standardization technology focal point, on the one hand, indicates that the state will continue to improve the construction of artificial intelligence medical device industry standard system, increase industry supervision, and promote the entire industry to be more standardized; On the other hand, it can be seen that the state pays attention to and attaches importance to the key field of artificial intelligence medical devices, and supports the priority development of emerging technologies. As an important review department of artificial intelligence medical devices in China, the medical device Technical Review Center of the State Food and Drug Administration (hereinafter referred to as the "device Review center") has been concerned about the development trend of artificial intelligence medical devices, and actively promote scientific research on artificial intelligence medical device supervision under the leadership of the State Food and Drug Administration.

Practice internal skills and consolidate the foundation

Artificial intelligence medical devices refer to medical devices using artificial intelligence technology. In 2017, the Center officially established an artificial intelligence working group to study the regulatory science of artificial intelligence medical devices. The members of the working group are from the relevant review departments of the organ Review Center, the innovative device review department, and the medical device registration and testing institutions of the national drug regulatory department, covering all aspects of the pre-market supervision of artificial intelligence medical devices.

After the establishment of the artificial intelligence working group, a variety of industry research has been carried out. First, through literature review to understand foreign artificial intelligence medical device regulatory policies and product review and approval, including the United States, the European Union and Japan and other countries and regions of the regulatory situation; The second is to carry out multiple exchanges with relevant enterprises, research institutions, and medical institutions to comprehensively understand the characteristics of artificial intelligence technology, product characteristics, industry development status, and clinical use risks; The third is to collect information about artificial intelligence medical device manufacturers, and deeply understand the product concentration of artificial intelligence medical devices, product development stage and production enterprise types. These investigations have laid a solid foundation for the subsequent scientific research work on the supervision of artificial intelligence medical devices.

On the basis of the previous research, the artificial intelligence working group combined with the relevant guiding principles and review experience of medical device software, and formed the "Deep Learning-Assisted Decision-making Medical device Software Review Points" (hereinafter referred to as the "Review Points") after several revisions. The "Review Points" takes deep learning-assisted decision-making medical device software as the starting point, focuses on the data quality control, algorithm generalization ability and clinical use risk of artificial intelligence medical devices, defines the review points of the full life cycle of artificial intelligence medical devices, and forms a consultation draft after expert discussion and modification.

Considering that there will be a considerable number of manufacturing enterprises applying for special review of artificial intelligence medical device innovation, the Artificial Intelligence working group has formulated special review points for artificial intelligence medical device innovation on the basis of the "Review Points" to promote technological innovation.

Artificial intelligence is widely used in the medical field, and which artificial intelligence products belong to medical devices has always been a concern of the industry. Drawing on international regulatory experience, the artificial intelligence working group believes that artificial intelligence products with medical device data as the object of processing and medical use belong to medical devices, and should be combined with the intended use of artificial intelligence medical devices, use scenarios and core functions to determine its management category. At present, experts have formed the corresponding regulatory policy proposals, and formally submitted to the relevant units of the State Food and Drug Administration.

Cooperate with external forces

On the basis of good cooperation with the Chinese Society of Biomedical Engineering in the early stage, the Center reached an agreement with the Medical Artificial Intelligence branch of the society, and the two sides will carry out close cooperation on scientific research on the supervision of artificial intelligence medical devices. In January this year, the two sides jointly held an expert seminar on "Review Points", with nearly 20 technical and clinical experts attending, providing valuable suggestions and opinions for the improvement of "Review Points".

In recent years, the Center has also cooperated with the China Academy of Information and Communications Technology to successfully apply for a number of national scientific research projects. On this basis, the two sides will further strengthen cooperation in scientific research on the regulation of artificial intelligence medical devices.

Service industries develop together

In April 2018, the US Food and Drug Administration (FDA) approved the IDx-DR diabetic retinopathy screening software for the market, causing widespread concern in the industry. The artificial intelligence working group published the "Introduction to the Market of IDx-DR Artificial Intelligence Sugar Network Screening Software in the United States" through the wechat public account of the Organ Review Center, analyzing the U.S. FDA's review requirements for artificial intelligence medical devices from the perspective of review, and guiding manufacturers to correctly understand the U.S. FDA's review ideas.

In February this year, the Center published "Deep learning, AI medical devices" in China Medical News, and forwarded it on the wechat public account of the Center, analyzing the development bottleneck of medical devices using deep learning technology, and guiding production enterprises to pay attention to the data quality control of products, algorithm generalization ability and clinical use risks.

In addition, the center has also participated in many AI medical device forum activities, such as the International Medical Device Regulators Forum (IMDRF) Shanghai Conference, the Chinese Biomedical Engineering Society Medical Device Innovation and Entrepreneurship Conference, the China Medical Device Supervision and Management International Conference (CIMDR), the China Digital Medicine Summit Forum Boao Conference, etc. Actively convey China's artificial intelligence medical device supervision ideas to the industry, and develop together with the industry.

On December 25, 2018, the Center jointly with China Health Media Group successfully held a public welfare training course on the registration and application of artificial intelligence medical devices, and conducted a comprehensive interpretation of the issues of concern to production enterprises. Nearly a thousand technicians and managers from medical equipment, artificial intelligence, Internet and other enterprises across the country participated in the training.

In the future, the center will further carry out scientific research on the supervision of artificial intelligence medical devices, formulate general review guidelines for artificial intelligence medical devices and key product review guidelines, take into account public health protection and promote technological innovation, and promote the healthy development of China's artificial intelligence medical device industry. In the face of the coming peak of artificial intelligence medical device registration, the examination center is ready.