2025 First Three Quarters Product Registration Report in China- Equipment Section
Data Description
This article focuses on reviewing and statistically analyzing the product registration data in key areas of China’s medical devices, aiming to gain insights into the product registration status and the development of innovative medical devices in the first three quarters of 2025.
Key areas include: [medical imaging, radiotherapy equipment, in vitro diagnostic equipment, surgical equipment, life support equipment]. Subdivided varieties include: under the five key areas, [computed tomography X-ray machines (CT), magnetic resonance imaging equipment, endoscopes, ultrasonic imaging diagnostic equipment, angiography X-ray machines (DSA), medical electron accelerators, blood/peritoneal dialysis equipment, digital X-ray diagnostic systems (DR), surgical robots, monitoring equipment, anesthesia machines, surgical microscopes, ventilators, high-frequency/radiofrequency surgical equipment, hematology analysis equipment, biochemical analyzers, laser surgical equipment, cardiopulmonary bypass equipment, etc.]
Ⅰ. Market share rate
Product scope: Product registration data in the five key areas of medical devices (see data description)
i. Overall Situation
In the first three quarters of 2025, the number of first-time registrations for Class II and Class III products in key areas of medical devices in China exceeded 700, a year-on-year decrease of 4.3%. Among them, Class II products accounted for 69%, a year-on-year decrease of 2.9%; Class III products accounted for 31%, a year-on-year increase of 4.4%.
（i）Field Distribution
From the perspective of various fields, among the first-time registrations of Class II and Class III products in key areas of China’s medical devices in the first three quarters of 2025, surgical equipment occupied an absolutely dominant position, accounting for 49% of the total, mainly Class II products; in vitro diagnostic equipment followed closely, with its product registrations highly concentrated in Class II products, accounting for as high as 96%.
From the perspective of specific fields, endoscopes in the category of surgical equipment led by an absolute advantage, with the number of product registrations accounting for nearly one-third of the total; high-frequency/rf surgical equipment and surgical robots also performed relatively well, with both exceeding 40 registrations; among medical imaging equipment, ultrasound had the leading number of registrations, while high-end imaging equipment such as CT and MR are mainly composed of Class III products; in in vitro diagnostic equipment, chemiluminescence immunoassays and hematology analysis equipment had relatively prominent registration numbers; life support equipment focused on monitoring equipment and ventilators, and the proportion of Class III products was relatively high.
Looking at the number of enterprise registrations in various fields, the top two are Shanghai Aohua Endoscopy Co., Ltd. and Suzhou Fuji Film Imaging Equipment Co., Ltd., both from the endoscope field, with 19 and 8 product registrations respectively.
（ii）Regional Distribution
From the perspective of provincial distribution, in the first three quarters of 2025, the first-time registrations of Class II and III medical device products in China were highly concentrated in the eastern coastal areas. The total number of product registrations in five provinces and cities, namely Guangdong, Jiangsu, Shanghai, Zhejiang and Beijing, accounted for nearly 70% of the national total. Among them, Guangdong and Jiangsu are far ahead in terms of total registrations, while Beijing shows significant high-end characteristics, with Class III products accounting for 48%.
(iii） Localization rate
In recent years, the localization rate of the first-time registrations of Class II and Class III products in key areas of medical devices in China has been continuously rising, steadily increasing from 90.6% in 2021 to 95.8% in the first three quarters of 2025. The dominant position of domestic devices in market competition has been increasingly consolidated.
ii. Import situation
In the first three quarters of 2025, the number of first-time registrations for imported medical devices in key fields in China was 32, a decrease of 36% compared with the same period last year.
(i)Field Distribution
Looking at various fields, in the first three quarters of 2025, the number of newly registered imported products in key areas of China’s medical equipment was mainly concentrated in surgical equipment, accounting for 66% of the total number of imported products, and nearly 60% of them were Class III products; in addition, all medical imaging equipment products were Class III.
From the perspective of segmented fields, the registration of imported medical devices is highly concentrated in the field of surgical operations. Among them, high-frequency/rf surgical equipment, endoscopes, and laser surgical equipment ranked among the top three. Except for endoscopes, most of them were Class III products with the highest technical thresholds.
Looking at the number of enterprise registrations in various fields, Fujifilm Corporation in the endoscope field had the highest number of registrations, with 4.
（ii） Regional distribution
From the perspective of the country/region of origin of the products, among the first-time registered imported products in China’s key medical device fields in the first three quarters of 2025, Japan, the United States, and Germany ranked the top three, and the total number of the three accounted for 75% of the total number of imported products.
Ⅱ .Localization Situation
Product scope: Product registration data in five key areas of medical devices
As of the end of September 2025, the localization rates of in vitro diagnostic and medical imaging equipment have both exceeded 87%, showing a steady growth trend. The field of surgical equipment has performed particularly well, with the current localization rate standing at 77.7% and an annual increase of as high as 7%, demonstrating a strong momentum of import substitution. However, the localization level of radiotherapy equipment remains relatively low, with a relatively limited improvement range.
Breakthrough in localization rate
From the perspective of secondary product categories, among the 60 valid and classified secondary categories in China’s key medical device fields, there are 28 secondary product categories with a localization rate of over 80%, accounting for 47%; there are also 28 categories with a localization rate between 50% and 80%, also accounting for 47%; while the number of categories with a localization rate still below 50% has been reduced to 4, among which 1 category is still completely dependent on imports.
Looking vertically, from 2021 to the end of September 2025, the number of secondary categories in China’s key medical device fields with a localization rate below 50% has shown a continuous downward trend. This change fully reflects the continuous improvement of China’s systemic breakthrough capability in key medical device fields.
Among the 4 categories with low localization rates (<50%) that still require intensive efforts, they involve three major fields: life support, cardiopulmonary bypass, and high-end imaging. Among them, the localization rate of household ventilators (life support) is 0%, which is currently a “bottleneck” product completely dependent on imports; the localization rates of high-frequency ventilators and cardiopulmonary bypass monitoring equipment are also at a relatively low level.
From 2021 to the end of September 2025, in the key fields of medical equipment in China, a total of 2 secondary categories have successfully achieved a zero breakthrough in localization rate, namely the surgical control system and the extracorporeal cardiopulmonary support and auxiliary system, which have extremely high technical barriers.
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
Source： Joinchain
Translated & edited：Bradyknown
