Recently, the unique identification (UDI) of medical devices in Hainan, Jilin, Guangdong, and other places has been actively promoted. All localities require and assist enterprises to complete UDI database submission and product code assignment according to relevant time nodes.

The unique identification of medical devices is a set of codes that uniquely identify medical devices, which is equivalent to the “ID number” of medical devices. UDI is essentially a kind of data information, which is not only big data for products but also big data for supervision – from manufacturers to product suppliers to patients, the flow direction of medical devices in the whole life cycle can be displayed, which is conducive to accurate supervision and ensure patient safety. Through the bar code or QR code, the information related to the registration and production of medical devices can be viewed, which is an important means to innovate the supervision mode and implement the main responsibility. From the perspective of promotion scope, it is the general trend to implement the whole life process supervision of medical devices in developed countries all over the world.

With the gradual integration of domestic UDI implementation standards and policy requirements with international standards, the international development of domestic medical device enterprises is expected to enter the “fast lane”. The data show that since the pilot implementation of the first batch of unique identification of medical device products on January 1, 2021, more than 600000 medical device products have been implemented and have a unique identification, most of which are consumable products, especially passive implant devices, neural and cardiovascular surgical devices and passive surgical devices, and most of them are class III products, It is basically consistent with the implementation varieties required by the policy.

The announcement on the second batch of implementation of the unique identification of medical devices issued in September this year requires that class III medical devices (including class III in vitro diagnostic reagents) produced from June 1, 2022, should have the unique identification of medical devices. The medical device registrant shall submit the product identification of the smallest sales unit in the registration management system, and upload the relevant data to the unique identification database of medical devices before the products are put on the market, so as to ensure the authenticity, accuracy, integrity, and traceability of the data. Business enterprises should do a good job in warehousing and outbound with codes to realize the traceability of products in the circulation link.

In October, the National Medical Insurance Bureau issued the notice prohibiting code breaking down and repeated code taking in the maintenance of medical consumables code information of medical insurance. The content points out that medical consumables maintenance enterprises need to sort out the maintained consumables product information with codes before October 31, 2021, and merge, modify and resubmit the data with broken down and repeated codes. If the correction is not completed within the time limit, the relevant product code will be deactivated.

Post time: Dec-06-2021