The Symposium on Quality and safety of 2023 medical devices was held in Shanghai

In order to further promote the medical device quality and safety special rectification work in-depth, effectively enhance the level of medical device quality and safety assurance, May 16, the State Food and Drug Administration held a seminar on the quality and safety of 2023 medical devices in Shanghai. The provincial bureaus participating in the conference reported on the progress of the special rectification work on the quality and safety of 2023 medical devices, the Verification Center and Information Center of the State Administration of China introduced the flight inspection of medical devices and the construction of post-marketing supervision informatization. Each participating unit conducts exchanges on the two topics of collection and collection of selected medical devices and production supervision by the registrant.

The meeting positively evaluated the medical device quality and safety special rectification work achieved phased results, and put forward specific requirements for the next step: first, Integrated Development and safety. We should bear in mind that the country is the largest, conscientiously carry out regulatory duties, continuously strengthen the regulatory system and capacity building, and effectively implement the“Three responsibilities” of enterprises, regulatory authorities and local governments, promote high-quality industrial development through strong regulation. Second, we must carry out in-depth investigation and rectification of risks and hidden dangers. Adhere to the problem-oriented, keep a close eye on key products and key links, prevent and control risks. We will continue to strengthen quality control over key products and key links, such as epidemic prevention and control medical devices, aseptic and implantable medical devices, national collection and collection of selected medical devices, and third-party online sales service platforms, to ensure that the frequency of supervision is not reduced, the intensity is not reduced, in-depth carding and investigation of all types of potential risks and timely and effective treatment. Third, we must continue to deepen risk consultation. We should focus on risks, products, enterprises, and disposal, organize regular consultations on medical device quality and safety risks, and implement a“List system” and a“Sales number system” for potential risks, form a risk management“Closed loop.”

The Higher Supervisory Department shall supervise and inspect the risk consultation of the Lower Supervisory Department. Fourth, we should continue to strengthen spot checks and monitoring. In accordance with the national medical device quality sampling work program requirements to do a good job. We will promote the development of a medical device adverse event system and effectively improve the ability to monitor, evaluate and handle adverse events. Fifth, we must crack down on illegal acts. Must insist on the case must be investigated, the law must be investigated, the implementation of illegal acts to the person requirements, timely transfer of suspected criminal clues, strengthen department coordination, forming a rectification synergy. Sixth, we should continue to strengthen the promulgation and enforcement of laws and regulations. We will continue to publicize laws and regulations and intensify training. 

In combination with medical device safety publicity week, we should actively carry out legal publicity, open channels for social supervision, enhance public awareness of safety, and ensure the safety of people's use of equipment. The meeting stressed that the drug regulatory authorities at all levels should have a deep understanding of the importance of strengthening the regulation of the collection and collection of the selected medical devices and the regulation of the registration of the registration of the production of entrusted products, and adopt a comprehensive and multi-measure approach to effectively strengthen the regulation of the registration of persons, we will further strengthen the training of“Key minorities” such as legal representatives, management representatives and quality principals, and fully implement the life-cycle quality management responsibilities of registrants. Strengthen supervision and inspection, strengthen information exchange, risk-oriented strict quality control, risk prevention, and ensure the safety of People's equipment.

Shandong Zhushi Pharmaceutical Group Co., Ltd., founded in 2003, has more than 5000 registered employees. After years of development, it has developed into a diversified industrial cluster integrating medical devices, polymers, cosmetics, health food, daily necessities and biological reagent production, enterprise management consulting and training, real estate economy, pharmaceutical transportation, pharmaceutical printing, etc.

Adhering to the concept of life, health and happiness, the Group provides you with full chain health services.

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