In order to effectively strengthen the investigation and management of hidden risks in medical devices, on May 26, the State Food and Drug Administration issued a notice requiring comprehensive strengthening of medical device quality and safety risk consultations. The notice points out that comprehensively strengthening medical device quality and safety risk consultations is of great significance to improving the pertinence, targeting and effectiveness of medical device quality and safety supervision.
Drug regulatory authorities at all levels must comprehensively strengthen consultation on medical device quality and safety risks, promptly discover and effectively deal with hidden medical device quality and safety risks, further implement the main responsibilities of enterprises and regulatory responsibilities, accelerate the establishment of a risk management mechanism that combines risk identification, risk assessment and risk management and control, and effectively ensure the quality and safety of medical devices in my country.
Conduct regular risk consultations
The notice requires that drug regulatory authorities at all levels should organize and carry out regular consultations on medical device quality and safety risks based on local work conditions. In principle, consultations on quality and safety risks of medical devices should be conducted once every quarter, and should be carried out immediately when major or urgent medical device quality and safety risks are discovered. When carrying out risk consultations, we must focus on risks, enterprises, products, and disposal, and closely focus on the hidden quality and safety risks discovered during the supervision of medical devices and reported by relevant departments.
Comprehensive review of risk information
Before risk consultation, drug regulatory authorities at all levels should comprehensively sort out the risk information discovered during supervision and inspection, supervisory random inspection, adverse event monitoring, online sales monitoring, complaint reporting, case investigation, product recall, public opinion monitoring and other regulatory work and reported by relevant departments. It is necessary to make full use of big data and other information technology means to conduct systematic sorting.
Carry out scientific risk analysis and judgment
Drug regulatory authorities at all levels must evaluate and analyze the risk information sorted out from various aspects such as product quality, social impact, legal risks, etc. through collective discussions, scientific analysis, and comprehensive judgment, evaluate the risk level, and determine appropriate disposal measures according to the risk level. We must focus on situations where quality system inspections and rectifications are not in place, multiple sampling inspections fail, adverse event reports indicate that products have unconventional risks, complaints and public opinion are concentrated, and other situations where risk factors are more prominent and risk causes are more complex.
Ensure risk handling is in place
Drug regulatory authorities at all levels must strictly implement corporate entities and local regulatory responsibilities, and promptly control and eliminate various risks and hazards in accordance with the disposal measures determined through consultation. It is necessary to urge enterprises to implement their main responsibilities, take effective measures to eliminate potential risks, and actively cooperate with regulatory authorities to handle risks.