Foreign Trade

Analysis of China's Medical Device Product Volume and Segmented Fields in 2021

日期 : 2021-04-28

China Business Intelligence Network News: At present, my country's medical device industry implements classified supervision and management. Supervision and management includes supervision of medical device products, production and operation enterprises. Supervision of products is aimed at verifying the safety and effectiveness of products, and classified management of medical device products. , Implementation of registration and filing system; supervision of production and operation enterprises aims to ensure stable product quality, safety and effectiveness, and implementation of filing and licensing systems for medical device production and operation enterprises. The details are shown in the figure below:


  Note: The validity period of the medical device registration certificate, medical device production license and medical device business license are all 5 years.


   Source: Compiled by China Commercial Industry Research Institute


   One, the number of products


   After more than ten years of rapid development, China's medical device industry has shifted from focusing on low-value consumables to investing in high-end and high value-added fields. In terms of medical device products, in 2020, the number of valid product registrations nationwide reached 18,7062, a year-on-year increase of 24.7%; among them, the first registration number of category II products was 15,156, and the first registration volume of category III products was 865.


  Data source: Home of Equipment, China Commercial Industry Research Institute


  Data source: Home of Equipment, China Commercial Industry Research Institute


   At the same time, the innovation capability of medical device products has been significantly improved. In 2020, the number of patent authorizations for enterprises reached 65,403, an increase of 10.79%; 86 products entered the innovation approval channel, an increase of 34.3%.


   2. Proportion of products


  According to the statistics of the Zhongcheng medical device big data platform, as of the end of December 2020, the number of effective medical device products nationwide reached 187062, an increase of 29.69% over the end of 2019. Among them, 107,284 were first-class products, 68,715 were second-class products, and 11,063 were third-class products.


  Data source: Zhongcheng Medical Equipment Research Institute, China Commercial Industry Research Institute


   Three, product segmentation areas


In terms of breakdown, the number one product registration is in vitro diagnostic reagents, with a total of 52,160 pieces; the second one is injection, nursing, and protective products, with a total of 44,631 pieces; followed by physiotherapy equipment, passive surgical equipment, dental equipment, orthopedics Surgical equipment, clinical examination equipment, medical imaging equipment, patient carrying equipment, medical rehabilitation equipment.


  Data source: Zhongcheng Medical Equipment Research Institute, China Commercial Industry Research Institute


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