The latest! NMPA publishes annual medical device regulatory statistics
On April 19, 2023, the State Medical Products Administration (NMPA) released the Annual Statistical Data of Drug Supervision and Administration (2022), which disclosed the acceptance, approval and supervision of medical devices.
01
Registration information for medical device filing
As of the end of 2022, there were a total of 134515 Class I medical device filing in China; 9226 imported class I medical devices have been filied; 87978 domestic Class II medical device registrations have been approved.
In 2022, there were over 32000 registered Class I medical devices in this period, and over 140000 at the end of the period; There were 12624 first registration approvals for Class II medical devices in China, and 87978 at the end of the period; 1844 domestic Class III medical devices were first registered and approved.
02
Medical device production and management enterprises
As of the end of 2022, there were a total of 32632 medical device production enterprises in China; There were 1.2097 million Class II and III medical device operating enterprises, with the largest number being Class II medical device operating enterprises, with a total of 801200.
There were 20640 production record certificates for Class I medical device products, 14693 production licenses for category II medical device products and 2509 production licenses for category III medical device products.
03
Supervision of medical devices
In 2022, a total of 24851 batches of local medical devices were randomly inspected.
In 2022, 31,000 medical device manufacturers were inspected nationwide, 3,109 of which were found to have violated laws and regulations.
A total of 1,543,600 medical device trading enterprises and users were inspected, including 47,500 illegal enterprises or units. 4245 flight inspections were conducted on medical device manufacturing enterprises, of which 389 were discontinued for rectification.
In 2022, a total of 33594 medical device cases were investigated and dealt with nationwide, with a value of 606.2438 million yuan, an increase of 22.89% and 7.83% respectively compared to 2021. 271 cases were transferred to judicial authorities, 3.99 times higher than in 2021.
04
Formulation and revision of medical device standards
In addition, the Annual Data of Drug Regulatory Statistics (2022) also lists the situation of inspectors. By the end of 2022, there were 5,110 qualified GMP inspectors for medical devices, and the total number of inspections in 2022 was 5,606.
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Source：Device Market
Translated & edited by Bradyknows
