Medical Devices Statistical Report Q1 2021

(i) Administrative acceptance of medical devices

During the reporting period, a total of 7,453 Class I medical devices were filed nationwide, of which 7,264 were domestic Class I medical devices and 189 were imported Class I medical devices. A total of 4,123 applications for initial registration were received nationwide, including 3,560 applications for initial registration of Class II medical devices in China, 377 applications for initial registration of Class III medical devices in China and 186 applications for initial registration of imported medical devices (including Hong Kong, Macao and Taiwan). A total of 3862 applications for renewal of registration were received nationwide, including 2460 applications for renewal of registration of Class II medical devices in China, 516 applications for renewal of registration of Class III medical devices in China, and 886 applications for renewal of registration of imported medical devices (including Hong Kong, Macao and Taiwan). For details, please refer to Exhibit 29.

(ii) Registration of medical device products

During the reporting period, a total of 3,358 initial registrations and 4,380 renewals of registrations for various types of medical devices were approved nationwide. Among them, 3,028 initial registrations for Class II medical devices, 228 initial registrations for Class III medical devices and 102 initial registrations for imported medical devices (including Hong Kong, Macao and Taiwan) were approved; 2,739 renewed registrations for Class II medical devices, 619 renewed registrations for Class III medical devices and 1,022 renewed registrations for imported medical devices (including Hong Kong, Macao and Taiwan) were approved.

(iii) Basic information of medical device manufacturing enterprises

As at the end of March 2021, there were 26,800 medical device manufacturing enterprises nationwide, of which: 15,500 enterprises could produce Class I products, 13,300 enterprises could produce Class II products and 2,097 enterprises could produce Class III products. For details, please refer to Schedule 30.

(iv) Basic information of medical device business enterprises

As at the end of March 2021, there were 939,900 enterprises dealing in Class II and Class III medical devices, of which 623,900 were dealing in Class II medical devices only, 76,600 were dealing in Class III medical devices only, and 239,400 were dealing in Class II and Class III medical devices at the same time. There were 776 enterprises providing third-party platform services for medical device online trading services. For details, please refer to Table 31.

(v) Daily supervision of medical device production

During the reporting period, the provincial and sub-provincial regulatory authorities inspected a total of 5,602 medical device manufacturers, 1,327 sterile medical device manufacturers for high-risk enterprises, 139 implantable medical device manufacturers for high-risk enterprises and 573 Class III medical device manufacturers for high-risk enterprises. For details, please refer to Schedule 32.

(vi) Daily supervision of the operation and use of medical devices

During this reporting period, the provincial and sub-provincial regulatory authorities inspected medical device business enterprises and user units 389,900 times, found 9,098 enterprises or units with violations and completed rectification of 10,200 times. For details, please refer to Schedule 33.

(vii) Local sampling and testing of medical devices

During the reporting period, 858 batches of medical devices were inspected in all provinces (regions and municipalities) and 51 batches failed, with a failure rate of 5.94%.

(viii) Investigation and handling of medical device cases

During the reporting period, a total of 3,606 medical device cases were investigated and handled nationwide, with a total value of RMB 10,065.13 million. During the reporting period, a total of 3,606 medical device cases were investigated and handled nationwide, with a total value of RMB 100,651,300, resulting in fines of RMB 81,279,800, confiscation of illegal income of RMB 4,427,200, banning of 12 unlicensed operations, destruction of 4 dens for manufacturing and selling counterfeits, ordering the suspension of production and business of 9 enterprises (including 2 manufacturing enterprises and 7 operating enterprises), and transfer of 11 cases to judicial authorities.


The top five provinces in terms of the number of medical device cases investigated were Sichuan, Henan, Hebei, Shandong and Anhui in that order. In terms of value, there were 3,514 cases with a value of less than RMB 50,000, accounting for 97.45% of the total number of medical device cases; 55 cases with a value of RMB 50,000 to RMB 200,000, accounting for 1.53%; 16 cases with a value of RMB 200,000 to RMB 500,000, accounting for 0.44%; 20 cases with a value of RMB 500,000 to RMB 10 million, accounting for 0.55%; and 20 cases with a value of RMB 10 million to RMB 100 million. There was one case with a value of RMB 10 million to RMB 100 million, which was investigated and dealt with by Sichuan; no medical device case with a value of over RMB 100 million was investigated and dealt with during the reporting period.


From the perspective of the main offenders, there were 249 cases of medical device manufacturers, accounting for 6.91% of all medical device cases; 1,615 cases of medical device business enterprises, accounting for 44.79%; 1,579 cases of medical institutions, accounting for 43.79%; and 163 cases of other subjects, accounting for 4.52%.


In terms of the types of violations, there were 1,102 cases involving the quality of medical devices, accounting for 30.56% of the total number of medical device cases; 345 cases violating the management of licenses, accounting for 9.57%; 321 cases violating the order of distribution, accounting for 8.90%; and 1,838 cases of other types of violations, accounting for 50.97%.