Food and drug administration of all provinces, autonomous regions and municipalities directly under the central government, and food and drug administration of xinjiang production and construction corps: Administrative measures for monitoring and reevaluation of adverse events on
medical devices (order no. 1 of the state administration of market supervision and administration, hereinafter referred to as the measures) have been promulgated and will take effect on January 1, 2019. In order to implement the measures and strengthen the monitoring and evaluation of adverse events on medical devices, the relevant matters are hereby notified as follows:
1. Fully understand the significance of adverse events monitoring of medical devices Adverse events monitoring of medical devices is an important part of post-marketing supervision of medical devices and an important measure to strengthen scientific supervision of the whole life cycle of medical devices and improve the effectiveness of supervision. In October 2017, the general office of the CPC central committee and the general office of the state council issued the opinions on deepening the reform of the review and approval system to encourage the innovation of drugs and medical devices (hereinafter referred to as the opinions), proposing to further establish a system for the direct reporting of adverse events by listing license holders and improve the reevaluation system of medical devices. The promulgation of the measures is an important measure to implement the opinions, which is of great significance to strictly prevent and control risks of medical devices and protect the safety of public devices.
2. Drug regulatory departments at all levels should fully understand the significance of the implementation of the measures, earnestly study, deeply understand and master the measures, and combine with the actual work in the region to earnestly pay attention to the implementation of all the work.Ii. Conscientiously carry out publicity and training of the measures. Drug regulatory departments at the provincial level should attach great importance to the implementation of the measures, formulate special plans for publicity and implementation of training, and do a good job in publicity and implementation of training. The national bureau will organize training for key personnel of provincial drug regulatory departments and monitoring institutions. Drug regulatory department at the provincial level to the organization responsible for the city and county drug regulatory departments and monitor the staff training, and strengthen the marketing authorisation holder, business director and monitoring staff training and guidance, coordination or jointly with the administrative department of public health at the same level to use the unit is responsible for monitoring work personnel to conduct training and guidance, layer upon layer is responsible for, as a whole. The training work should be matched with high-quality teachers, so as to unify the lecture notes, promote learning through examination and ensure the quality of training.
3. Implement the systems stipulated in the measures. All provincial-level drug regulatory authorities shall urge the holders of the marketing licenses of medical devices to earnestly fulfill the responsibilities of adverse event monitoring, including improving the quality management system, staffing institutions and personnel, establishing corresponding working systems, timely analysis, evaluation and report, and continuing research on the safety of listed products.The monitoring and evaluation institutions of the state bureau should accelerate the improvement of the national medical device adverse event monitoring information system. All provincial drug regulatory authorities shall urge the holders of medical device marketing licenses to register as system users in accordance with the provisions of the measures, proactively maintain their user information, report adverse events of medical devices, and continuously track and process monitoring information.In order to ensure the implementation of the measures, the national bureau will release the guiding principles of adverse events monitoring, reevaluation, adverse events monitoring and inspection, and regular risk evaluation report, etc. to guide the listing license holders, operating and using units and regulatory departments at all levels to carry out relevant work as required.Iv. Comprehensively strengthen the supervision and inspection of adverse events monitoring of medical devices. Drug regulatory authorities at the provincial level shall incorporate the monitoring and reevaluation of adverse events into the inspection of the quality management system for the holders of the marketing licenses of medical devices, carry out key inspections in accordance with the conditions stipulated in article 67 of the measures, and take timely control measures and seriously investigate and deal with any illegal behaviors. To promote construction and management, strengthen the responsibility consciousness of listing license holders in carrying out adverse event monitoring and reevaluation, guide enterprises to improve the level of carrying out adverse event monitoring and reevaluation, and ensure that the listing license holders of medical devices implement the main responsibility.The national bureau will timely organize supervision and inspection of the monitoring of adverse events of medical devices in some provincial bureaus, and promote the implementation of the measures.
