Adverse Event Monitoring Guideline For Medical Device Registrant

Introduction

In order to guide the medical device registrant and filer (hereinafter referred to as registrant) to establish a sound medical device adverse events monitoring system, promote the monitoring of adverse events of medical devices, and timely and effectively control the post market risks of medical devices, the guideline is formulated according to Management Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices(Order No. 1 of the State Administration for Market Regulations National Health Commission of the People’s Republic of China) (hereinafter referred to as Measures). The medical device registrant mentioned in this guideline has the same meaning as the medical device marketing license holder mentioned in the Measures. The purpose of the guideline is to provide registrant with help on how to comply with regulations and rules, and to provide reference for medical device supervision personnel, explaining how to achieve the requirements and goals of the drug regulatory agency in a fair, consistent and effective manner. The guideline does not have legal effect so alternatives to the principles and practices described in this article can be accepted as long as there are sufficient reasons. However, these alternatives shall be discussed with relevant parties (persons) in advance to avoid the situation that they do not meet the requirements of applicable laws or regulations.

As an inevitable result of the above requirements, the drug regulatory agency reserves the right to request information or materials, or stipulate the conditions not specified in this article. So that the drug regulatory agency can adequately evaluate the safety, effectiveness and quality control of products. The drug regulatory agency undertakes to ensure the rationality of these requirements and make clear records of decisions.