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In the medical field, every device carries the weight of life. How to ensure their safety and effectiveness? Globally, the promotion of the UDI (Unique Device Identification) system is becoming the key to this mission.
Imagine if there is a way to accurately track the entire process of each medical device from production to use, then the safety of patients will be unprecedentedly guaranteed. This is the charm of the UDI system. By giving medical devices a globally unique identity code, we can achieve accurate management of the entire life cycle of the device. In my country, with the formal implementation of the "Medical Device Unique Identification System Rules", the UDI system has moved from pilot to full promotion. This is not only a positive response to international standards, but also an important step in the modernization of my country's medical device management.
In terms of policy background, the implementation of the unique medical device identification (UDI) has far-reaching historical and practical significance. Since 2012, the International Medical Device Regulators Forum (IMDRF) has begun to promote the global unification of the UDI system, aiming to enhance the traceability and safety of global medical devices. As a member of IMDRF, my country has actively responded to this international trend.
In 2016, the former State Food and Drug Administration issued the "Medical Device Unique Identification System Rules (Draft for Comments)", marking the official launch of my country's UDI system construction. After years of research and preparation, in July 2019, the State Food and Drug Administration and the National Health Commission jointly issued the "Medical Device Unique Identification System Pilot Work Plan", which officially kicked off my country's UDI system pilot. In 2020, with the revision of the "Medical Device Supervision and Administration Regulations", the UDI system was officially included in the regulatory requirements, which marked that the UDI policy has entered the full implementation stage in my country. The implementation of UDI not only helps to improve the traceability of medical devices, ensure product quality and patient safety, but is also an important measure for my country's medical device regulatory system to be in line with international standards.
As a member of the industry, UpnMed Medical Equipment Co., Ltd. officially used UDI on August 1, 2021 to start the layout of the UDI system. From every product on the production line to every patient's feedback, we are weaving a safe net with UDI. This is not only a technological innovation, but also a manifestation of respect for life. The promotion of the UDI system will make the management of medical devices more transparent and efficient. We look forward to the fact that in the near future, every device can be accurately tracked and every treatment can be optimally guaranteed. This is a revolution about the quality of life, and we are the participants in this revolution. Medical device UDI is not just a code, it is the lifeline connecting manufacturers, medical institutions and patients. In this process, every firm step forward is the deepest respect for life. Let us work together to promote this great change for the safety and dignity of every life.
