The State Food and Drug Administration requires comprehensively strengthening medical device quality and safety risk consultations

People's Daily Online, Beijing, May 28 (Reporter Sun Hongli) In recent years, my country's medical device industry has developed vigorously, and innovative products have continued to emerge. At the same time, the problem of unbalanced and insufficient development still exists, and violations of laws and regulations occur from time to time, which seriously damages the rights and interests of public health.

According to the official website of the State Food and Drug Administration, in order to effectively strengthen the investigation and management of potential risks of medical devices, the State Food and Drug Administration issued a notice recently, requesting to comprehensively strengthen the consultation on the quality and safety risks of medical devices. The notice pointed out that comprehensively strengthening medical device quality and safety risk consultation is of great significance to improving the pertinence, targeting and effectiveness of medical device quality and safety supervision.

Drug regulatory authorities at all levels should comprehensively strengthen consultations on the quality and safety risks of medical devices, timely discover and effectively deal with potential risks of medical device quality and safety, further implement the main responsibility of enterprises and the regulatory responsibilities of regulatory authorities, and accelerate the establishment of risk identification, risk assessment and risk management and control systems. The integrated risk management mechanism effectively guarantees the quality and safety of medical devices in my country.

Regular risk consultations

The notice requires that drug regulatory authorities at all levels should regularly organize and carry out medical device quality and safety risk consultations based on local work conditions. To carry out risk consultations, it is necessary to focus on risks, enterprises, products, and disposal, and closely focus on the hidden quality and safety risks discovered in the supervision of medical devices and notified by relevant departments.

Comprehensively sort out risk information

The drug regulatory authorities at all levels should comprehensively sort out the information found in the supervision and inspection, supervision and sampling inspection, adverse event monitoring, online sales monitoring, complaint reporting, case investigation, product recall, public opinion monitoring and other regulatory work before risk consultation and relevant departments. Risk Information. It is necessary to make full use of big data and other information technology means to systematically sort out.

Scientifically carry out risk research and judgment

The drug regulatory authorities at all levels should evaluate and analyze the risk information sorted out through collective discussions, scientific analysis, and comprehensive research and judgment, from the aspects of product quality, social impact, legal risk, etc. treatment measures. It is necessary to focus on the situation where the quality system inspection and rectification are not in place, the repeated random inspections are unqualified, the adverse event report indicates that the product has unconventional risks, the complaints and reports and public opinion are more concentrated and other risk factors are more prominent and the risk causes are more complicated.

Ensure risk management is in place

Drug regulatory departments at all levels must strictly implement the corporate and territorial regulatory responsibilities, and timely control and eliminate various hidden risks in accordance with the disposal measures determined by the consultation. It is necessary to urge enterprises to implement their main responsibilities, take effective measures to eliminate hidden risks, and actively cooperate with regulatory authorities to do a good job in risk disposal.