Full supervision of medical devices, how to do business?
Medical equipment products to achieve safe and effective, a major focus is "quality management" and the quality of medical devices should be managed throughout the product lifecycle. Should pay attention to is that in a complex environment faced by medical devices, and laboratory and production environments have a huge difference, to strengthen the use of medical devices quality management, for the protection of people with firearms safe and effective is critical.
October 21, China's food and drug regulatory authorities promulgated the "medical devices quality supervision and management measures", which for medical device quality management has important theoretical and practical significance, meaning that all the important aspects of the whole process of China's medical device regulation were We have a legal basis.
In order to investigate in detail a significant impact on China's new medical device regulations for medical device quality management system brings, associate professor invited Jiang Haihong resolved this issue, and look forward to the broad masses of medical device regulators, industry practitioners involved in published opinions.
General Secretary Xi Jinping has proposed the "four most stringent" requirements on food and drug supervision and management work, this is a matter under the new situation of the safety of human life and health products for several major starting point and goal of regulation. General Secretary of the instructions, point out the food and drug supervision theme is "strict supervision" category is "full supervision." In the field of medical devices, with the October 21 State Food and Drug Administration of Work (CFDA) issued the "medical devices quality supervision and management approach" (hereinafter referred to as the "Rules"), medical equipment throughout the strict supervision of the times is a big step forward.