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 Total |
| 01 Active Surgical Instruments | 3,598 | 0.91% |
| 02 Passive Surgical Instruments | 10,154 | 2.56% |
| 03 Nerve and Cardiovascular Surgical Instruments | 2,349 | 0.59% |
| 04 Orthopaedic Surgical Instruments | 717 | 0.18% |
| 05 Radiation Therapy Equipment | 606 | 0.15% |
| 06 Medical Imaging Equipment | 8,787 | 2.22% |
| 07 Medical Examination and Monitoring Equipment | 35,169 | 8.87% |
| 08 Respiratory, Anaesthesia and First Aid Equipment | 18,226 | 4.60% |
| 09 Physical Therapy Equipment | 23,181 | 5.85% |
| 10 Blood Transfusion, Dialysis and Extracorporeal Circulation Devices | 10,889 | 2.75% |
| 11 Medical Device Disinfection and Sterilization Equipment | 1,912 | 0.48% |
| 12 Active Implant Instruments | 583 | 0.15% |
| 13 Passive Implant Instruments | 3,313 | 0.84% |
| 14 Infusion, Care and Protective Equipment | 166,734 | 42.07% |
| 15 Patient Carrying Devices | 1,468 | 0.37% |
| 16 Ophthalmic Instruments | 5,743 | 1.45% |
| 17 Stomatology Instruments | 4,394 | 1.11% |
| 18 Obstetrics and Gynaecology, Assisted Reproductive and Contraceptive Devices | 12,971 | 3.27% |
| 19 Medical Rehabilitation Equipment | 816 | 0.21% |
| 20 TCM Equipment | 4,179 | 1.05% |
| 21 Medical Software | 72 | 0.02% |
| 22 Clinical Testing Devices | 19,725 | 4.98% |
| IVDs | 2,935 | 0.74% |
| Pending for categorization | 57,824 | 14.59% |
| Total | 396,345 | 100% |
By Jacky Li. Contact Cisema to learn more.
