Analysis of Medical Device Innovation and Priority Approval in China

Ⅰ.Products entering the device innovation approval pipeline, 2017-2023

i.Products entering the device innovation approval channel from 2017 to 2023
From a trend perspective, the number of devices entering the innovation approval channel in 2023 increased by 35% compared to 2022. Since 2019, the overall number of products entering the device innovation approval channel showed an upward trend every year.

ii、 Trends in approved innovative medical device products from 2017 to 2023
The number of innovative medical device products approved annually from 2017 to 2022 continued to increase, with a growth rate exceeding 20%. There was a slight decrease compared to 2022 in 2023.

iii. Distribution of products entering the innovation approval channel from 2017 to 2023 among various review agencies
From 2017 to 2023, the innovative devices that were reviewed by various audit institutions were concentrated in the National Medical Products Administration; Among the local drug regulatory bureaus, the number of products that were reviewed and entered the innovation approval channel by drug regulatory bureaus in Zhejiang, Guangdong, Beijing, and Shandong was relatively prominent compared to other provinces.

iv. Distribution of products entering the device innovation approval channel and approved for market from 2017 to 2023
From 2017 to 2023, the main product categories entering the device innovation approval channel were passive implantable devices (16%), active surgical devices (13%), in vitro diagnostic reagents (11%), and medical imaging devices (10%). The approved product categories were mainly passive implantable devices (13%), medical imaging devices (12%), active surgical instruments (10%), and in vitro diagnostic reagents (9%).

v. Regional distribution of domestic devices entering device innovation approval channel and approved enterprises, 2017-2023
From 2017 to 2023, the products that entered the innovation approval channel for medical devices were mainly distributed in Beijing (18%), Zhejiang (16%), Guangdong (15%), Jiangsu (12%), and Shanghai (12%) according to the provinces and cities where the enterprises were located. The cumulative approved innovative medical device products were mainly distributed in Beijing (21%), Zhejiang (19%), Guangdong (14%), Shanghai (12%), and Jiangsu (9%) according to the province and city where the enterprise was located.

Ⅱ..Analysis of China’s Innovation Approval Equipment Situation in 2023

i. The number of devices entering the innovation approval channel in 2023
The products subject to innovation approval were mainly domestically produced Class III devices reviewed by the National Medical Products Administration; In addition, some Class II devices also entered the innovation approval channel, mainly distributed in drug regulatory bureaus in Jiangsu, Beijing, Guangdong, Sichuan, Hunan and other places.

ii .Distribution of provinces and cities entering the approval channel for medical device innovation in 2023
From the distribution of enterprises entering the innovation approval channel in 2023, they were mainly located in provinces and cities such as Jiangsu, Beijing, Guangdong, Zhejiang, and Shanghai.

iii． Distribution of Product Categories Entering Innovative Device Approval in 2023
In 2023, a total of 178 medical devices entered the innovation approval channel. From the distribution of products entering the device innovation approval channel in 2023, there were more active surgical instruments, passive implantable instruments, in vitro diagnostic reagents, and medical imaging instruments, and the research and development activity in related fields is relatively high.

iv .Distribution of innovative device categories approved for listing in 2023
In 2023, a total of 100 innovative medical device products were approved for market, mainly active surgical instruments, medical imaging instruments, and passive implantable instruments.

Ⅲ.Analysis of China’s Priority Approval of Medical Devices in 2023

i. The amount of data entering the priority approval channel for medical devices from 2017 to 2023
The number of products entering the priority approval channel for medical devices in 2023 was 135, a year-on-year increase of 5%. There may be some differences in the priority approval policies for medical devices between the national and local drug regulatory bureaus. Currently, there are reasons for public disclosure, mainly for products that have technological innovation and are national or provincial projects.

ii .Distribution of various audit institutions in 2023
In 2023, from the perspective of review agencies, priority approval for medical devices was concentrated in the drug regulatory bureaus of provinces and cities such as Sichuan, Tianjin, Chongqing, and Fujian.

iii.Distribution of product categories that received priority approval and approval for medical devices in 2023

In 2023, a total of 135 medical devices entered the priority approval channel, among which there were more in vitro diagnostic reagents and clinical testing devices, indicating that these types of products were relatively easy to qualify for priority approval.

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

This article is excerpted from Chapter 3 of the China Medical Device R&D Blue Book (2024)

Source：Yaozhi Medical Device
Translated & edited：Bradyknown