October 15, 2018
At the end of August, the China Market Supervision Administration (the leader institute of NMPA) has officially published the “Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices” (hereinafter referred to as the “Measures”), with an aim of reinforcing the post-market surveillance of medical devices, and efficiently handling the risks associated with post marketing of medical devices in a timely and effective manner. The estimated timeline for the official implementation thereof will be on January 1, 2019.
The “Measures” defines the responsibilities and obligations of the manufacturer and the license holder for taking part in post-market activities, including (a) medical device adverse event monitoring, (b) re-evaluation report and (c) supervisory management. Moreover, China government lays emphasis on the responsibility of manufacturers to initiate adverse event reporting to NMPA soon as they find out that their device has an adverse event either domestic or abroad. As part of the reporting process, manufacturers are also required to submit a medical device re-evaluation report to NMPA, in order for the latter to closely evaluate the medical device suspected to cause a certain adverse event.
The special points to note are the following
1. Obligations of the license holder:
(1) Establishing a medical device quality management system that includes the monitoring and re-evaluation system for medical device adverse events;
(2) Having the relevant institutions and personnel to be involved in the monitoring of adverse events of medical devices;
(3) Proactively collecting and reporting the medical device adverse events to the official monitoring organization in a timely manner in accordance with the time limit specified in the present Measures;
(4) Conducting investigations, analysis and evaluation on the occurrence of adverse medical device incidents in a timely manner, taking measures to control risks, and releasing risk information in a timely manner;
(5) Conducting continuous research on the safety of listed medical devices, and writing periodic risk assessment reports as required;
(6) Proactively carry out re-evaluation of medical devices;
(7) Cooperating with the NMPA and the official monitoring organization to conduct the investigation of adverse events.
2. If an imported medical device has a medical device adverse event outside the country, or if the domestic medical device has a medical device adverse event outside the country, and the control measures are taken, the agent designated by the overseas holder or the holder of the domestic medical device shall be informed. Within 24 hours, report the adverse medical conditions of imported medical devices, the control measures shall be taken within the territory to the NMPA and the national monitoring agency, and forward to the NMPA branch of the provinces for timely reporting.
3. If the adverse event is the individual case, the adverse event leading to death shall be reported within 7 days; the serious injury or death shall be reported within 20 days. In the event of a group adverse event, the NMPA branch of the province shall be reported by telephone or fax within 12 hours when the adverse event occurred.
4. If the adverse event monitoring indicate that the medical device may exist the defects, the holder shall take the initiative to carry out re-evaluation on the medical device, which shall be based on the product safety and effective information, clinical data and experience gained from the market. The holder shall re-evaluate the original submission documentation during the original registration application. The latest submission date of the re-evaluation report is determined based on the degree of influence and severity of the adverse event.
5. The holder shall conduct the continuous safety research for the listing medical devices, such as summarizing and analyzing the adverse event reports, monitoring risk information in domestic and abroad, evaluating the risks and benefits of the products, and recording the risk control measures taken. The holder shall complete the periodic risk evaluation report of the product every year from the date of the first approval of the product.
In order to ensure that the adverse reaction monitoring system can be successfully promoted nationwide, the National Center for ADR Monitoring issued five draft guidelines on adverse event notification on September 20 and seek for public comment until October 20. The following is a summary of every guidelines:
1. Guideline for Monitoring Medical Device Adverse Events: The content covers the scope of responsibility and related work procedures for the following units in the adverse event monitoring system.
a. Manufacturer/ License holder
b. Operation enterprise
c. The end user of medical device
d. City-level and county-level medical device adverse event monitoring agencies
e. Provincial medical device adverse event monitoring agency
f. National Medical Device Adverse Event Monitoring Agency
g. City-level and county-level NMPA branch
h. Provincial NMPA branch
2. Guidelines for the Scope of Medical Device Adverse Event Reporting: This Guideline clearly indicates the definition and scope of medical device adverse event reports. In addition, innovative medical devices is required to report all medical device adverse events during the first registration period.
3. Guideline for Key Monitoring of Medical Device Adverse Events: Define and regulate the key monitoring of medical device adverse events, and explain the responsibilities and related work procedure of monitoring agencies and license holder.
4. Guidelines for How License Holder to Collect and Report the Adverse Events of Medical Devices: This Guideline is to regulate the license holder on the collection and reporting of medical device adverse events. The holders shall establish a collection of adverse event information from the medical device enterprise, users (medical institutions) and patients. In addition, the holder shall actively collect the academic literature, the post-marketing adverse events, and expand the information channel from the network, digital media and the social platforms.
5. Guidelines for the Inspection Work of the Medical Device Adverse Event: in order to improve the quality of the medical device adverse event monitoring system, NMPA would refer to this guideline to conduct the inspection work on license holder. The guidelines outlines the checkpoints for the monitoring of adverse events in medical devices and would be as the reference for official auditors.
License holder: Refers to the holder of the medical device registration certificate. The foreign manufacturer shall assign a local agency as the license holder in China.
Adverse events: Refers to all kinds of harmful events that have occurred in the listed medical device under normal use and cause or may cause harm to the human body.
Adverse Event Monitoring: Refers to the process of collecting, reporting, investigating, analyzing, evaluating, and controlling adverse events of medical devices.
Re-evaluation: The process of re-evaluating the safety and effectiveness of listed medical devices and taking corresponding measures.