Beijing Releases the 2021 Annual Report on Medical Device Statistics of the Drug Regulated Administration, with A Aotal of 943 Manufacturers

The Following content is selected from the medical device section of the statistical report：

III.Medical device supervision and management

i．Medical device approvals

A total of 323 records were filed for class I medical devices in the city in 2021; 661 domestic class II medical devices were accepted for the initial registration with 624 were approved;, while 1075 were acceptd for the continuation of the registration with 975 were approved, respectively; 1611 change of licensing matters  were accepted with 1400 were approved; 305 cases change of registry matters were accepted with note / revocation 11 cases. By the end of December 2021, there were 2095 records for type 1 medical devices in the city and 6081 records for type 2 medical devices in the city.

ii.Basic information of medical device manufacturers

As of the end of December 2021, there are 943 medical device manufacturers in the city. Among them, there are 398 manufacturers of Class I medical device products, 481 manufacturers of Class II medical device products, 291 manufacturers of Class III medical device products, 129 key state supervision enterprises, and 13 municipal key supervision enterprises.

iii. Basic situation of medical device management enterprises

As of the end of December 2021, there are 21,195 enterprises engaged in the operation of class II medical devices only, 1,173 enterprises engaged in the operation of Class III medical devices only, and 9,604 enterprises engaged in the operation of both class II and class III medical devices at the same time. There are 11,140 equipment wholesale enterprises, 8,505 medical equipment retail enterprises, 3,959 enterprises only engaged in the operation of sterile medical devices, 1,828 enterprises only engaged in the operation of implantable medical devices, and those engaged in the operation of both sterile and implantable medical devices. There are 3079 enterprises engaged in both sterile and implantable medical devices, 3379 enterprises engaged in in vitro diagnostic reagent (IVD) business, 486 medical equipment operation enterprises providing storage and distribution services for other medical equipment production and operation enterprises, and 3205 enterprises engage in online sales of medical equipment；There are 41 companies that provide third-party platform services for online transaction services.

iv.Daily supervision of medical device manufacturing enterprises　　

In 2021, the city’s regulatory agencies at all levels inspected a total of 1,841 medical device manufacturers/times , including 439 manufacturers/times  of Class I medical device products, and 1 /time failed inspection; 736 enterprises /times containing second-class medical device products were inspected and 201 /times failed the inspection. 702 manufacturing enterprises/times  containing class-II of medical devices were inspected, and 200 failed to pass the inspection. 416 national key supervision enterprises/times  and 48 municipal key supervision enterprises /times were inspected. There were 267 total inspections of high-risk sterile medical device manufacturing enterprises/times, of which 74/times failed the inspection; There were 226 inspections of manufacturers/times of implantable medical devices, and 53 /times failed inspections; 621 class -III medical device manufacturers /times were inspected, and 198/times failed the inspection. There were 226 inspections of manufacturers/times of implantable medical devices, and 53/times failed inspections; 621 class-III medical device manufacturers /times were inspected, and 198 /times failed the inspection. 230 unannounced inspections of medical device manufacturers/times, and 26/times of request to stop production for rectification. There were 22 production enterprises/times with violations of laws and regulations, 634 /times rectifications were completed, and 11 production enterprises/times were investigated and punishied.

v.Daily supervision of medical device operating enterprises and user units　

In 2021, the city’s regulatory agencies at all levels inspected a total of 23,018 medical device business enterprises, user units and third-party platforms /times serving the medical device online trading network; There are 485 business enterprises /times were carried out unannounced inspection. 201 enterprises or units /times existed violations of laws and regulations. 190 enterprises or units /times completed rectification, and 175 enterprises or units were investigated and punished. Among them: 13,072 medical device operating companies /times were inspected, 135 operating companies/times violated laws and regulations, 127/times completed rectifications, and 138/times were filed for investigation and punishment; Among them，13,072 medical device operating companies/times were inspected, 135 operating companies/times violated laws and regulations, 127 /times rectifications were completed, and 138 /times were filed for investigation and punishment; 9,697 medical device /times use units were inspected, 61 use units  /times were found to be in violation of the law, 60 /times were completed and rectified, and 37  /times were filed and investigated. 249 third-party platforms /times for medical device online trading network services were inspected, 5 third-party platforms /times were found to be in violation of laws and regulations, 3 /times were completed and rectified, and 0 were filed and investigated.

Vi. Medical device sampling and testing

In 2021, 123 medical device enterprises in the city were sampled and tested, all of which were production-related, with a total of 200 batches sampled and 16 batches failing. 121 batches of class II medical devices were sampled and tested by device category, with 10 batches failing. 79 batches of class III medical devices were sampled and tested, with 6 batches failing.

vii. Investigation and punishment of medical device cases

In 2021, 355 medical device cases were investigated and handled, with a value of RMB 3,186,100, fines of RMB 6,759,700, confiscation of illegal proceeds of RMB 321,700 and the banning of one unlicensed business. The main sources of medical device cases in 2021 were 221 routine supervision and special inspections (62.25%), 38 notifications from other departments (10.70%), 30 complaints and reports (8.45%), and 30 supervision and random inspections (8.45%). %), 21 law enforcement inspections (5.92%) and 15 others (4.23%).　 From the perspective of the illegal subjects, there are 230 cases in which the illegal subjects are operating enterprises, accounting for 64.79% of the total number of medical device cases; 89 cases in which the illegal subjects are medical institutions, accounting for 25.07% of the total number of cases; the cases in which the illegal subjects are production enterprises a total of 33 cases, accounting for 9.30% of the total number of cases.

viii.　 Investivation and punishment of  medical device infringement and counterfeiting cases　

In 2021, 3 cases of medical device production and sales that did not meet the standards were filed, 2 cases of administrative punishment cases were disclosed, and 2 cases of administrative punishment cases that met the requirements for disclosure.

ix．GMP inspector status of medical devices

The city has 161 GMP inspector qualifications for medical devices in 2021. From the located unit, 88 people are from administrative agencies, 40 people from inspection and detection institutes, 24 people from review centers, and 9 people from other units.As of the end of December 2021, a total of 601 people have been inspected in the city.

Sourc：Beijing Municipal Drug Administration

Edited and translated by： Bradyknows

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