Definition: A medical device product that is the first in China, whose technology is at the international leading level, and has significant clinical application value
Innovative medical devices refer to technological innovation activities led by the applicant , owns product core technology invention patent rights in China according to law, or has obtained invention patent rights or the right to use them in China through transfer in accordance with the law; or the application for core technology invention patents has been disclosed by the patent administration department of the State Council. Secondly, the main working principle/mechanism of the product is the first in China. The product performance or safety has been fundamentally improved compared with similar products. It is technically at the leading international level and has significant clinical application value. Furthermore, the main working principle/mechanism of the product is the first in China, the product performance or safety has been fundamentally improved compared with similar products, the technology is at the international leading level, and it has significant clinical application value.
Development background: Policy support promotes industry development
As early as 2015, my country issued the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices", opening the door to the development of medical devices in my country. The road to reform. In 2017, the Central Committee of the Communist Party of my country and the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" and further launched a series of reform measures to integrate some relatively mature and effective regulatory measures and systems. ization; implement the medical device marketing authorization holder system, optimize and integrate industrial resource allocation; implement a unique identification system for medical devices step by step to further improve product traceability; add regulations that allow expanded clinical use to demonstrate regulatory wisdom.
Development status: Enterprises are highly motivated to innovate and promote rapid industrial development
Since the 18th National Congress of the Communist Party of China, my country has attached great importance to technological innovation and implemented an innovation-driven development strategy. Since 2014, the State Food and Drug Administration has helped many innovative medical devices and urgently needed clinical medical devices to be quickly approved for marketing by establishing priority review and approval, green channels and other measures for innovative medical devices. Enterprises are highly motivated to innovate and the industry is developing rapidly.
As of May 26, 2022, there are 160 innovative medical devices approved for marketing by the my country Food and Drug Administration. Judging from the approval situation by year, the number of innovative medical devices approved for marketing by the my country Food and Drug Administration has shown a fluctuating upward trend in recent years; from 1 in 2014 to 35 in 2021. From January to May 2022, there were 26 innovative medical devices approved for marketing by the my country Food and Drug Administration, which was the same as in 2020.
Note: The deadline is May 26, 2022.
From a regional perspective, 95% of the innovative medical devices approved for marketing in my country belong to local regions. There are 8 products affiliated to foreign companies; they come from 6 companies including Medtronic, NovoCure Ltd., Edwards Lifesciences LLC, Abbott Vascular, Sequent Medical Inc., W.L. Gore & Associates, Inc.
Note: The deadline is May 26, 2022.
Note: The deadline is May 26, 2022.
From a provincial and municipal perspective, most of the innovative medical device products approved for marketing come from Beijing, Shanghai, Guangdong, Jiangsu and Zhejiang; 46, 28, 25, 23, respectively. 11.
——The above data refers to the "China Medical Device Industry Market Foresight and Investment Strategic Planning Analysis Report" by the Qianzhan Industry Research Institute