In 2022, NMPA conducted the review and approval of innovative medical devices and clinically urgent use medical devices in accordance with procedures, made new breakthroughs in the localization of high-end medical equipment, approved 55 (189 in total) innovative medical devices such as the first domestic proton therapy system, and gave priority approval to 77 medical devices (126 in total). The number of innovative medical devices approved increased by 57.1% compared with 2021. more…
According to the report of the Development Status and Trends of China’s Medical Device Industry released by Roland Berger, an international management consulting company, on the 22nd, the size of China’s medical device market is expected to reach 958.2 billion yuan (RMB, the same below) in 2022, with a compound growth rate of about 17.5% in the past seven years, and has jumped to the second largest market in the world outside the United States. more…
On February 21, 2023, the official website of the National Standards Commission published the 2023 National Standards Project Guidelines (hereinafter referred to as the Guidelines). The mandatory national standards recommended national standards and key project areas of national standard samples have been clarified, and specific requirements have been made for application requirements and materials, including related standards of medical devices, which deserve attention. more…
Just now, the NMPA released the Announcement of the NMPA, National Health Commission, National Healthcare Security Bureau on the Third Batch of Implementation of UDI (No. 22 of 2023)” (hereinafter referred to as the “Announcement”). more…
In recent years, the domestic medical device industry has been advancing against the trend. The competent department has issued a number of policies to encourage domestic medical devices to accelerate innovation. Now it is showing the strong resilience and innovative development advantages of the domestic medical device industry. more…
