NMPA: Medical Device Standards and Innovative Medical Devices in China

In recent years, China has focused on supporting the development of high-end and innovative standards for artificial intelligence medical devices, new biomedical materials, and other fields, striving to fill the gap in innovation standards. As of now, there are 1978 medical device standards, including 272 national standards and 1706 industry standards; There are 269 mandatory standards and 1709 recommended standards, which basically cover various professional technical fields of medical devices. Standardization organizations have been established for medical robots, artificial intelligence medical devices, medical equipment industry and applications, traditional Chinese medicine devices, and more. There are now 39 medical device standardization organizations.

The consistency between China’s medical device standards and international standards has reached 95%. Since 2023, two international standards led by China have been successfully released, and the revision of five international standards has been progressing in an orderly manner. The international standards such as Testing Methods for Algorithm Performance of Lung Imaging Assisted Analysis Software for Artificial Intelligence Medical Devices have been successfully approved. Two Chinese experts have been recommended to be elected as the Chairman of IEC SC 62B and Vice Chairman of TC62.。

As of now, 277 innovative medical devices have been approved for market launch, including 27 approved since 2024, involving multiple high-end medical devices such as bronchial navigation operation control systems, fundus imaging assisted diagnosis software for retinal lesions, extracorporeal ventricular assist devices, renal artery radiofrequency ablation devices, etc., covering multiple fields such as surgical robots, artificial intelligence medical devices, and cardiopulmonary support assistance systems.

From the perspective of product types, the innovative medical devices approved in 2024 include 5 passive medical devices, 2 in vitro diagnostic reagents, and 20 active medical devices, covering 10 categories of medical devices. Among them, there are more active surgical devices and active implantable devices. 17 domestically produced medical devices, mainly distributed in Beijing, Shanghai, Jiangsu, Zhejiang, and Guangdong; 10 imported medical devices.

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：NMPA

Translated & edited: Bradyknow