Overview of the Medical Device Classification and Distribution in China
This article provides an overview of the medical device classification and distribution of medical device manufacturers in China. Hope that will help you to select your preferred medical device supplier. Let’s get started, enjoy it!
Classification of Medical Devices
In China, medical devices are regulated by the National Medical Products Administration, or NMPA(formerly the China Food and Drug Administration, or CFDA). The main responsibilities of NMPA is to supervise the safety of drugs, medical devices and cosmetics.
The NMPA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices generally pose the lowest risk to the patient and/or user and Class III devices pose the highest risk.
Class I medical devices are generally deemed low risk, product tests are sometimes required. Such as bandage, some scalpel, some hemostatic forceps, etc.
Class II medical devices are generally deemed moderate risk, product tests are always required and clinical trials are sometimes required. Such as medical surgical mask, medical gowns, vacutainer blood collection tube, medical gloves, infrared thermometer, medical electronic(digital) thermometer, etc.
Class III medical devices are seen as the highest risk, product tests and clinical trials are always required. Such as medical ventilators, anesthetic machines, COVID-19 test kits, etc.
Distribution of Medical Device Manufacturers
There are 22079 medical devices manufacturers by June 30th, 2020 in China. There are 10195 companies producing Class I medical device, 10290 companies producing Class II medical device, 1981 companies producing Class III medical device.
Guangdong province has the largest number of medical devices manufacturers, there are 3748 suppliers. Such as Mindray and BGI Genomics are located in Shenzhen. Wondfo Biotech and Daan Gene is located in Guangzhou. The second one is Jiangsu province(2823). Yuwell(Yuyue Medical) is located in Nanjing. The third one is Shandong province(2089). WEGO is located in Weihai, SHINVA is located in Zibo.
The distribution of medical device manufacturers in China as follow:
I hope you’ve found this article useful. If you have any questions or tips on locating medical device suppliers in China, be sure to comment.
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