On 03 April 2020, the NMPA of China has recently issued Guidelines for Medical Device Registrants to carry out adverse event monitoring on medical devices. The guidance was issued following requirements settled in “Decision on Medical Device Adverse Monitoring and Re-Evaluation”.
The guideline lays out a framework to improve the adverse event monitoring system of medical devices, promote adverse event monitoring of medical devices as well as control the post-marketing risk of medical devices in an efficient and timely manner.
The guideline is applicable and to be used as a reference for registrants who are responsible for registering adverse event monitoring system and inspection for medical devices in the People’s Republic of China.
The scope of the guidelines defines procedures to establish a management system that includes a leading group for adverse events reporting, designation of departments, management of medical devices adverse monitoring reports, investigation into the adverse events, and the emergency treatment for the said events.
Besides that, the flow of the working procedures is also defined for medical devices’ adverse events such as death, serious injury, and potential injury.
Most importantly the guideline requires that the registrant and filers who are the medical device marketing license holders report to the Drug Supervision and Administration Department and the Competent Health Department of the province about the adverse event within 12 hours by telephone or fax.
Further, the annexure of the guidance also includes a sample form along with steps to fill the adverse event reports.
The guideline will further promote registrants to comply with regulations and provide guidance for medical device supervisors to fulfill the goals of the NMPA in a fair, consistent, and effective manner.
More information pertaining to the Adverse Event Reporting Guidance for Medical Device can be referred here:-
http://www.cdr-adr.org.cn/ylqx_1/Medical_aqjs/Medical_aqjs_smsxggg/202004/t20200413_47302.html
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