On October 23, with the establishment of the National Medical Products Administration Information Center in Beijing Medical Innovation Park BioPark, the six major centers of the National Medical Products Administration have been "assembled". The six centers are the Drug Review Center of the National Medical Products Administration's directly affiliated units, the Food and Drug Review and Inspection Center, the Drug Evaluation Center (National Drug Adverse Reaction Monitoring Center), the Medical Device Technical Review Center, the Administrative Affairs Acceptance Service and Complaint Reporting Center, and the Information Center (China Food and Drug Regulatory Data Center).

Beijing Yizhuang gathers regulatory resources to provide strong guarantees for the high-quality development of biotechnology and the big health industry in terms of enterprise industry administrative approval, qualification certification, etc. In the National Bureau's administrative affairs acceptance service hall, 10 windows are neatly arranged to handle the acceptance, consultation, charging, and certification of administrative licensing matters such as drugs, medical devices, and cosmetics. At the same time, it also provides services such as cosmetics technical review, over-the-counter drug conversion, and pre-acceptance technical consultation for medical devices. Enterprises can make appointments online to conduct face-to-face on-site consultations and exchange policies and regulations. Medical device regulatory resources have achieved "compression" in time and space, and enterprises will greatly save time, energy and costs in handling these links.

According to relevant persons in charge of Beijing Economic and Technological Development Zone, the six centers are the six core business departments of the State Drug Administration. The establishment of Beijing Yizhuang is of great significance to the innovative drug and medical device R&D companies in the zone. For example, the Drug Review Center is the drug registration technical review agency of the State Drug Administration. In accordance with the relevant regulations on drug registration management, it is responsible for organizing the technical review of drug registration applications; the Medical Device Technical Review Center is responsible for the acceptance and technical review of domestic third-class medical device products and imported medical device products that apply for registration. From the perspective of industry rules, review is a key node for industry entry. Beijing Yizhuang has increased its service guidance for the registration and listing of innovative drugs and devices by integrating the regulatory resources of the State Drug Administration.

Medical devices have become one of the most watched areas in my country's big health industry. With policy support and high-end technological innovation, my country's medical device innovation is ushering in an explosive moment. Cyber Blue Medical Devices learned at the "Beijing Forum on International Biopharmaceutical Industry Innovation" held recently that Du Huiqin, deputy director of the Medical Device Registration Department of the State Drug Administration, said: "In recent years, the overall operating income of Chinese medical device companies has steadily increased. In 2022, the operating income of China's medical device industry reached 1.3 trillion yuan, with a growth rate of about 12%, significantly higher than the overall growth rate of the pharmaceutical industry. China has become the world's second largest market for medical devices. The number of medical device manufacturers has reached more than 33,000." Du Huiqin said that recently, my country's medical device standards have exceeded 2,000, and the standardization of medical devices has reached a new level.

The State Drug Administration continues to make efforts to encourage medical device innovation. So far, it has approved 297 innovative medical devices and given priority approval to 144 medical devices. Domestic brain pacemakers, carbon ion therapy systems, proton therapy systems, 5.0T magnetic resonance imaging systems, panoramic dynamic PET/CT0, third-generation artificial hearts, artificial blood vessels and other high-end medical devices have been launched one after another, realizing the localization of high-end medical devices. In the next stage, the National Medical Products Administration will provide pre-review services for high-end medical devices, support "Made in China, New in the World", and support the innovative development of products such as artificial intelligence, medical imaging, medical biomaterials, medical robots, and brain-computer interfaces. After my country's low- and medium-end medical devices have basically achieved domestic substitution, high-end medical devices are in urgent need of filling the gap. At present, the total output of medical device patents in my country is on the rise, catching up with or even surpassing imported brands in some high-end device fields, but barriers still need to be overcome in most fields.

At the "Promoting High-quality Development" series of thematic press conferences held by the State Council Information Office in September this year, it was mentioned that four key support areas of artificial intelligence, new medical biomaterials, high-end medical imaging and medical robots should be established to break the "blocking points" and "difficulties" of industrial development. The National Medical Products Administration has selected 48 artificial intelligence and 40 biomaterial high-end medical device projects, and given key support when applying; and established three innovation cooperation platforms for artificial intelligence medical devices, biomaterials and high-end medical equipment. For innovative drugs and medical devices that are supported by the state, we will strengthen service guidance in review and approval, inspection and verification, etc.; speed up the review and approval of products urgently needed in clinical practice, include qualified products in the priority review and approval process, shorten the time limit for technical review, registration verification, registration inspection and other links, and speed up the approval process; actively support the introduction of innovative drugs and devices into hospitals and medical insurance; encourage multinational companies to transfer original research chemical drugs, biological products and high-end medical equipment to domestic production. With the comprehensive upgrade of all elements of "government, industry, academia, research, medicine, finance and service", my country's medical device innovation will enter a new era of change.

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