Li Yanan, chief of the Medical Device Supervision Office of the Tianjin Medical Products Administration, Zhu Bochen, director of the Tianjin Monitoring Center for Adverse Reaction of Drugs, Medical Devices and Cosmetics, and the relevant leaders and personnel of the Tianjin First and Fifth Medical Products Administration Offices, the Nankai District Administration for Market Regulation, and the key monitoring centers and monitoring sentinel point participated in the meeting. Minkang was invited to attend the meeting as an enterprise representative.
At the meeting, the related comrades introduced the background of the key monitoring work of blood glucose meter adverse events in Tianjin during the "14th Five-Year Plan", and explained the key monitoring work plan in detail, emphasized the work responsibilities, methods and requirements of all participating units.
Lan Chunbo, Director of Minkang Quality Department, as the representative of the key monitoring registrant, made a special report on the Key Monitoring Plan for Adverse Events of Blood Glucose meter during the “14th Five-Year Plan" at the meeting. Lan Chunbo introduced the enterprise profile of Minkang to the leaders at the meeting, explained in detail the functional characteristics of MK-SY 01Pro blood glucose meter, as well as the current development, application and sales of Minkang blood glucose meter products. Combined with the actual requirements of the key monitoring work in Tianjin, he focused on the key monitoring mechanism of Minkang blood glucose meter adverse events, the division of responsibilities of the monitoring team, internal monitoring methods, working procedures and requirements.
Speaking of how the enterprise cooperates to complete the key monitoring work, Lan Chunbo, director of Minkang, said that Minkang will actively and fully implement the requirements of the key monitoring work of adverse events of medical devices during the "14th Five-Year Plan" of the National Medical Products Administration and Tianjin Medical Products Administration, complete the key monitoring task of blood glucose meter adverse events of sentinel point registrants, analyze product risks, propose risk control measures, and provide technical support for the safe and reasonable use of medical devices in clinical practice.
The meeting stressed that all relevant units should, in accordance with the unified deployment requirements of the National Medical Products Administration, solidly promote the key monitoring work of the "14th Five-Year Plan". First, we should raise awareness and fully understand the importance of key monitoring work; second, we should refine our responsibilities and ensure that all tasks are carried out in detail; third, we should innovate methods and enrich the means of medical device risk management; fourth, we should promote the effective transformation of key monitoring results.
As a national high-tech enterprise committed to the research, development, production and sales of rapid detection products for chronic diseases using biosensor technology, Minkang has always been focusing on the development of all-round services for diabetes. This time, Minkang was invited to participate in the key monitoring work of adverse events of provincial blood glucose meter products is not only the recognition of Minkang blood glucose meter product research and development and quality management system, but also the incentive for enterprises to constantly explore the innovative forms of blood glucose meter products and constantly improve product quality.
Minkang will further strengthen the supervision of the whole life cycle of blood glucose meter products, improve the awareness of the company's relevant departments and personnel on the adverse event monitoring work and the awareness of active reporting, improve the ability of risk pre-warning and control, and make new and greater contributions to promoting the high-quality development of the blood glucose meter industry.