NMPA releases its 2019 Annual Report for Medical Device Adverse Event Monitoring and Reporting

On 29.04.2020, the National Center for Adverse Drug Reaction (ADR) Monitoring of NMPA (National Medical Products Administration) released its 2019 Annual Report, providing an overview of China’s progress for medical device adverse event monitoring and reporting. Key highlights are:

The total number of adverse event reports reduced by 2.61%

In 2019, there were 396,345 adverse events reported in China, a decrease of 2.61% as compared to 2018.

Severe injury reporting cases decreased sharply by 10.17%

In 2019, 0.05% (213 reports) of the total adverse events reported death cases, an increase of 70.6% as compared to 2018.

In 2019, 6.74% (26,723 reports) of the total adverse events reported severe injury cases, a significant decrease of 10.17% as compared to 2018.

Mainly medical institutions and consumers

In 2019, 357,799 adverse events were reported by users (medical institutions and consumers), 8,600 adverse events were reported by NMPA Legal Agents and 29,833 adverse events were reported by manufacturers.

42.07% of the total adverse events reported related to infusion, care and protective equipment

Medical Devices
(According to the NMPA Classification Catalogue for Medical Devices [2017])Number of
Adverse Events Reports% of Total01 Active Surgical Instruments3,5980.91%02 Passive Surgical Instruments10,1542.56%03 Nerve and Cardiovascular Surgical Instruments2,3490.59%04 Orthopaedic Surgical Instruments7170.18%05 Radiation Therapy Equipment6060.15%06 Medical Imaging Equipment8,7872.22%07 Medical Examination and Monitoring Equipment35,1698.87%08 Respiratory, Anaesthesia and First Aid Equipment18,2264.60%09 Physical Therapy Equipment23,1815.85%10 Blood Transfusion, Dialysis and Extracorporeal Circulation Devices10,8892.75%11 Medical Device Disinfection and Sterilization Equipment1,9120.48%12 Active Implant Instruments5830.15%13 Passive Implant Instruments3,3130.84%14 Infusion, Care and Protective Equipment166,73442.07%15 Patient Carrying Devices1,4680.37%16 Ophthalmic Instruments5,7431.45%17 Stomatology Instruments4,3941.11%18 Obstetrics and Gynaecology, Assisted Reproductive and Contraceptive Devices12,9713.27%19 Medical Rehabilitation Equipment8160.21%20 TCM Equipment4,1791.05%21 Medical Software720.02%22 Clinical Testing Devices19,7254.98%IVDs2,9350.74%Pending for categorization57,82414.59%Total396,345100%

By Jacky Li. Contact Cisema to learn more.