Original from: yaoZH

1. Number of Medical Device Manufacturers in China

 

As of August 2023, the top three provinces in terms of the number of medical device manufacturers are Guangdong, Shandong and Hebei, with Guangdong ranking first with 8,493 medical device manufacturers. Chongqing has a total of 756 medical device manufacturing enterprises, ranking 19th in China.

 

 

2. Overview of Medical Device Manufacturer Licensing in China    

 

Companies engaged in the production of Class II and Class III medical devices within China should apply for a production license from the local drug administration department. As of November 2023, the top three provinces in terms of the number of registered medical device manufacturing permit companies are Jiangsu, Guangdong and Zhejiang.

 

 

3. Overview of Medical Device Manufacturer Filings in China    

 

Companies engaged in the production of Class I medical devices file with the local drug administration department. As of November 2023, the top three provinces in terms of the number of registered medical device production filing companies are Jiangsu, Shandong and Guangdong.

 

 

4. Overview of Medical Device Operating Companies Licensing in China    

 

The operation of Class I medical devices require no licensing and filing, the operation of Class II medical devices is managed by filing, and the operation of Class III medical devices is managed by licensing. As of November 2023, the top three provinces in terms of the number of registered medical device operating company licensing are Shandong, Henan and Guangdong.

 

5. Overview of Medical Device Operating Companies Filing in China    

 

As of November 2023, the top three provinces in terms of the number of registered medical device operating companies filing are Shandong, Henan and Guangdong.

 

 

Conclusion

 

The number of medical device manufacturers and operating companies in China has been growing fast in recent years. 

 

By the end of 2022, the number of companies with the production capacity of Class I medical devices in China reached 20,640, the number of Class II and Class III medical device manufacturers was 17,202, and the number of medical device operating companies exceeded 1.2 million, which is a rapid growth momentum. The expanding scale of enterprises has provided strong support for the overall development of the medical device industry.

 

In terms of product registration, the number of medical device product registrations filed in Chongqing from 2019 to 2023 shows an overall upward trend. 

 

Currently, China's medical device registrations are mainly concentrated in the more economically developed coastal provinces. Although the number of registered products in the Chongqing region ranks in the top ten nationwide, there is a large gap between it and leading provinces such as Jiangsu and Guangdong.