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Notice Of The Comprehensive Department Of The State Food And Drug Administration On The Implementation Of The Measures For The Administration Of Monitoring And Re Evaluation Of Adverse Events Of Medical Devices

2022-03-28 Author: Comprehensive Department of the State Food and Drug Administration Views: 0

The food and Drug Administration of all provinces, autonomous regions and municipalities directly under the central government and the food and Drug Administration of Xinjiang production and Construction Corps:

The administrative measures for the monitoring and re evaluation of adverse events of medical devices (Order No. 1 of the State Administration of market supervision, hereinafter referred to as the measures) has been issued and will come into force as of January 1, 2019. In order to implement the measures and strengthen the monitoring and evaluation of adverse events of medical devices, the relevant matters are hereby notified as follows:

1、 Fully understand the significance of adverse event monitoring of medical devices

Adverse event monitoring of medical devices is an important part of post marketing supervision of medical devices. It is an important measure to strengthen the 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 and encouraging the innovation of drugs and medical devices (hereinafter referred to as the opinions), which proposed to further establish the system of direct reporting of adverse events by listing permit holders and improve the re evaluation system of medical devices. The release of the measures is an important measure to implement the opinions, which is of great significance to strictly prevent and control the risks of medical devices and products and protect the safety of public equipment. Drug regulatory departments at all levels should fully understand the significance of the implementation of the measures, carefully study, deeply understand and master them, and earnestly grasp all the work of implementation in combination with the actual work of their own regions.

2、 Earnestly carry out the publicity, implementation and training of the measures

All provincial drug regulatory departments should attach great importance to, earnestly publicize and implement the measures, formulate special publicity and implementation training plans, and earnestly do a good job in publicity and implementation training. The State Administration will organize training for key personnel of provincial drug regulatory departments and monitoring institutions. The provincial drug regulatory department shall organize the training of the staff of the municipal and county-level drug regulatory departments and monitoring institutions, strengthen the training and guidance of the listing license holders, the principals of trading enterprises and monitoring staff, cooperate with or work with the administrative department of health at the same level to carry out training and guidance for the staff responsible for monitoring in the user units, so as to be responsible at all levels and promote overall progress. The training work should be accompanied by high-quality teachers, so as to achieve the unity of speeches and promote learning through examination, so as to ensure the quality of training.

3、 Earnestly implement the systems stipulated in the measures

All provincial drug regulatory departments shall urge the holders of medical device marketing licenses to earnestly perform the responsibility of adverse event monitoring, including improving the quality management system, allocating institutions and personnel, establishing corresponding working systems, timely analyzing, evaluating and reporting, and conducting continuous research on the safety of listed products.

The monitoring and evaluation institutions of the State Administration of medical devices should speed up the improvement of the national adverse event monitoring information system of medical devices. All provincial drug regulatory departments shall urge the holders of the marketing license of medical devices to register as system users in accordance with the provisions of the measures, actively maintain their user information, report adverse events of medical devices, and continuously track and deal with the monitoring information.

In order to ensure the implementation of the measures, the National Bureau will successively issue guiding principles such as adverse event monitoring, re evaluation, adverse event monitoring inspection and regular risk assessment report of medical devices to guide the listing license holders, business users and regulatory authorities at all levels to carry out relevant work as required.

4、 Comprehensively strengthen the supervision and inspection of adverse event monitoring of medical devices

All provincial drug regulatory departments shall incorporate the supervision and inspection of adverse event monitoring and re evaluation into the inspection of the quality management system of the holders of the marketing license of medical devices, carry out key inspections according to the circumstances specified in Article 67 of the measures, and take control measures in time and seriously investigate and deal with violations found. Promote construction and management through investigation, strengthen the responsibility consciousness of listing permit holders in carrying out adverse event monitoring and re evaluation, guide enterprises to improve the work level of adverse event monitoring and re evaluation, and ensure that medical device listing permit holders implement the main responsibility.

The National Bureau will timely organize supervision and inspection on the monitoring of adverse events of medical devices in some provincial bureaus to promote the implementation of the measures.

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