On April 10, the NMPA issued the “Guideline for Medical Device Market Authorization Holders (MAHs) to Conduct Adverse Event Monitoring”. Based on Decree 1 Medical Device Adverse Event Reporting and Reevaluation, it is to guide medical device registrants and filers to carry out adverse event monitoring. The guideline contains the scope of application, general requirements, management system, working procedures and related instructions.
Legal representative will play a far more significant role with Decree 1 and the Guideline than ever before. China Med Device, LLC is NMPA certified legal representative. We can help you fulfill the pre and post market legal agent requirements without your need to setup office in China. For more details on legal representative related regulations, email us at info@ChinaMedDevice.com.
MAH is the holder of the medical device marketing license. Companies that register devices do not have to be the manufacturers. They may commission one or multiple qualified contract manufacturing organization(s) to manufacture the approved medical devices. Therefore, the MAH system has major implications for the developers who have limited manufacturing capabilities.
According to in the “Extension of Pilot Program for Market Authorization Holder (MAH) system” published on August 1, 2019, the system has implemented in 21 provinces and municipalities in China.
A medical device adverse event (AE) refers to various harmful events that have occurred on the market and have occurred or may cause human injury under normal use.
The MAH shall bear the main responsibility for the monitoring of medical device AE, and shall establish an AE monitoring system:
NMPA asks manufacturers to pay attention to the following:
Yearly Adverse Event Report became mandatory since the Jan 1, 2019 when Decree 1 Medical Device Adverse Event Reporting and Reevaluation took effect. To comply with NMPA reporting requirements, please contact us at info@ChinaMedDevice.com.
For 2019 Adverse Events Report published on April 26, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.