Author：MeCan Medical–ultrasound machine manufacturers
The "Medical Devices Weiying 1 Identity System Rules" released in October 2019 shows that medical device only 1 logo refers to the code that is attached to the medical device product or packaging Perform 1 sexual identification. Medical Devices Model 1 Identity system consists of medical device only 1 identification, only 1 identification data carrier, and only 1 identification database.
Earlier, the phenomenon of non -code or one -object multi -code phenomenon in circulation and use in circulation was seriously affected, which seriously affected the refined zhun identification of medical device production, circulation, and use and other links, which was difficult to achieve effective supervision and management.
After implementing UDI, it is expected to achieve "one weapon, one yard, one identity", from the source production, business circulation, to clinical use of "one code Unicom". Medical Devices Modeling 1 Identity system is conducive to strengthening the traceability management of medical devices. With this encoding like an "ID card", it can identify problem products in time and achieve rapid recalls. At the same time, it also plays an important role in cracking down on counterfeit and inferiority.
Article 38 of Chapter 38 of the New "Regulations on the Management of Medical Device" stipulates that according to the category of medical device products, the medical device only 1 identification system is implemented step by step to realize the traceability of medical equipment. Essence
According to the official website of the GUO Family Pharmaceutical Bureau, the pilot work of medical device Wei only 1 identification system was carried out in July 2019, and it continued to December 31, 2020. After the pilot, starting on January 1, 2021, the first batch of medical device only launched the 1 logo work was fully launched, and the medical devices of 64 varieties of 9 categories were included in the first batch of implementation. The pacemaker, vascular brackets, joint prosthesis, and plastic filling materials such as high -risk third categories of medical devices are high -risk.