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.
Who is MAH?
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.
What is AE?
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.
Who has the Major Responsibility?
The MAH shall bear the main responsibility for the monitoring of medical device AE, and shall establish an AE monitoring system:
- appoint certain number of personnel appropriate to its size to engage in adverse event monitoring
- collect, report, investigate, analyze, and evaluate medical device defects and adverse events
- take effective measures to control risks in a timely manner and publish risk information
- conduct continuous research on the safety of medical devices
- conduct risk assessment and key monitoring work as required and submit relevant reports
- cooperate with national and local supervision and management departments and medical institutions to conduct inspection
- establish an information sharing mechanism with the legal representative to exchange and re-evaluate information in a timely manner
- register as a user of the National Medical Device Adverse Events Monitoring Information System (http://maers.adrs.org.cn), report AE related information through the system, and maintain user and product registration information in a timely manner
Key Takeaways for Manufacturers
NMPA asks manufacturers to pay attention to the following:
- any AE that may cause serious injuries or death should be reported
- for individual medical device adverse events, registrants shall establish AE information collection channels based on product characteristics.
- for group medical device adverse events, the registrant shall immediately suspend production and sales after discovering, and notify the users to stop using related devices
- registrants shall establish key product monitoring plan in accordance with the requirements of local NMPA
- Innovative medical devices are included in key monitoring. Innovative device registrants shall submit key product monitoring plan, analysis and evaluation reports to the national monitoring agency every six months within the first registration cycle
- innovative medical devices shall report all AE within the first registration cycle
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.