Medical network on April 13 - the review authority cannot be concentrated in the hands of a few people, and shall establish "grading, shunt, segmented" review of new pattern 

 

Surgical masks, mri, CT, stents, heart valves, patients on the title may not be unfamiliar. They have a common distinguished name, medical apparatus and instruments. In disease prevention, diagnosis and treatment, medical apparatus and instruments are playing an increasingly important role. In recent years, under the strong support of national policy, China's medical equipment industry to flourish, output value of the annual average growth rate of 20%, increased to 1.5 production enterprises, all kinds of application for registration of 12000 each year. 

 

If the medical equipment industry is regarded as "front desk", then, review of medical equipment can be thought of as "background". The strong support of the rapid development of the front desk without the background. In recent years, the medical device review causes also obtained the rapid development, in the review task quantity increasing cases, completed in 2016 more than 2016 technical evaluation, ensure the products review project in and out of the basic balance. Grades are very good, but the board should not be ignored, review of medical equipment is still faces many risks, needs to be resolved. Over the past two years, we reform the review system mechanism, and strive to defuse the risks. 

 

Optimization of the review process. Before the review mode is given priority to with single the referee, as well as a review of member from the beginning to the end. Along with the development of science and technology changes with each passing day, the professional division of labor is more and more fine, individual staff expertise, alone in the security risk of review of the quality of product is safe and effective on growing, is not to cater to the reality of the review. Therefore, process optimization and reengineering evaluation become a choice. Only focus on the introduction of the project team before review mechanism, the registration system verification, the technical committee collective decision-making mechanism and review mechanisms, such as quality supervisory PingZha mechanism to enhance the management review process, improve the quality of the review and efficiency. From the reform of the medical instrument technical review center for two years practice, the introduction of the new system, has scientific review level obviously improved. 

 

The prevention and control of the risk. Facts have proven that the larger discretion is often a greater risk of integrity. To power "life and death to prevent" part of the review is "hunting", not only involving personal integrity self-discipline, more related to the public with machinery is safe and effective. From the perspectives of checks and balances, the review authority can't focus on a few hands, and should establish "grading, shunt, segmented" review of the new model, will review the task according to how easily are divided into different levels, and its allocation to different paths in the review, the review resources with significant matters together, collective decision-making, so as to completely change the single presiding review mode. At the same time, supplemented by information system for the review staff information, review progress net can check the information such as query, the review report content, make the review run in the sun all the time, accept social supervision, reduce the risk of integrity. 

 

Improving the quality of the review. Is an urgent need to build up the books PingZha, internal audit and management review, supervision mechanism, support for technical evaluation and related process in a full range of quality control. 

 

Medical devices must be clearly aware that the review system reform is still on the road, still need to "nail" the spirit of a hammer hammer and knock. 

 

(the author for the administration of state food and drug supervision and administration of medical apparatus and instruments, director of the center for technical evaluation)