The state official website news, the state held a medical device network transaction management risk meeting. The meeting pointed out that the medical device network transaction monitoring found that individual enterprises stationed on the platform have illegal and irregular problems, the relevant e-commerce platforms should attach great importance to seriously against the requirements of laws, rules and regulations, the e-commerce platform to fulfill their legal obligations to carry out a comprehensive self-examination and rectification.
The meeting pointed out that the State Drug Administration continues to improve the construction of regulations and systems for the supervision of medical device online transactions, deploying drug regulatory departments around the world to carry out in-depth medical device "net" action and medical device quality and safety risks and hidden dangers of the investigation, to increase the monitoring of the medical device online transactions and illegal behavior crackdown, and continue to solidify the medical device online transactions. The main responsibility of the third party platform of medical device network transaction service has been achieved.
The meeting requested that the third-party platform of medical device network transaction service should improve the political position and insist on the people's supremacy. Strict implementation of the main responsibility of the platform, to ensure the quality and safety of medical device network sales, as a political task, to strengthen internal management and personnel training, to ensure that the network trading services continue to comply with.
The second is to strictly qualify the qualification audit, strict admission. Seriously check the entry of the enterprise medical device license, registration certificate and filing certificate information, be sure to do comprehensive, accurate, complete and detailed, if necessary, to the licensing department to consult and verify the qualifications of medical equipment business will not have the conditions of the enterprise "outside the door".
Three to increase dynamic monitoring, timely disposal report violations. To continuously strengthen the monitoring force, innovative monitoring methods, to strengthen the platform of medical equipment network trading information monitoring frequency and intensity, found in violation of the "supervision and management of medical equipment regulations" "supervision and management of the sale of medical equipment network approach" and other provisions should be immediately taken to stop the network trading services and other measures, suspected of violating the law of the stationed enterprises, will be relevant clues to report to the drug regulatory authorities in a timely manner, and to help Provide relevant evidence and materials, and collaborate to do a good job in the investigation and disposal of violations of the law.
The participating third-party platform of medical device network trading service said it will continue to optimize the qualification audit system, increase the input of professional auditors, improve the frequency of manual inspection and audit efficiency, regulate the market order of medical device network trading on the platform, and resolutely crack down on the illegal behaviors of medical device network trading, and effectively protect the safety of consumers in purchasing and using medical devices.