Approximately 70,000 medical devices have been coded in Guangdong Province, a summary of the UDI implementation process in many places

Recently, the Guangdong Provincial Drug Administration held an on-site meeting to promote the pilot work of the unique identification system for medical devices in Shenzhen.
At this stage, the progress and effectiveness of the pilot work for the unique identification system for medical devices are summarized
.
As of December 3, 276 enterprises in Guangdong Province had reported 69,669 pieces of data to the medical device unique identification database, and 236 enterprises had released 67,444 pieces of data.
Among them, 130 of the three types of enterprises had filled in data and 110 had released data
.
Medical Device Identification (Unique Device Identification, UDI) is the electronic ID card of medical device products, which can realize the general inspection of medical devices throughout the life cycle.
It is currently the best method for the traceability management of medical devices and is widely used internationally.

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China's UDI pilot work started in 2019.
On January 1, 2021, the first batch of high-risk third-class medical devices of 69 medical device varieties in 9 categories will be formally implemented unique identification
.
According to data from Zhongcheng Digital Science, since its implementation, more than 600,000 medical device products have been implemented and have unique identifications, most of which are consumable products, especially passive implantable devices, neurological and cardiovascular surgical devices and passives Surgical instruments, and most of them are Class III products
.
In order to achieve the traceability of medical devices as soon as possible, many provinces and cities have deployed ahead of schedule to accelerate the implementation of UDI
.
At present, some provinces and cities have completed the implementation of UDI ahead of schedule, and some provinces and cities have expanded the scope of implementation based on actual conditions
.
The Sichuan Provincial Food and Drug Administration has made it clear in promoting the UDI work node that it will complete all three types of medical device product codes, data uploading and maintenance from September to November 2021
.
In December 2021, the completion status of the enterprises and units included in the implementation will be inspected and accepted
.
The Hebei Provincial Food and Drug Administration requires that medical devices (all three categories) produced from November 1, 2021 should have a unique identification of medical devices
.
The Shandong Provincial Food and Drug Administration expects that all the third-class medical device manufacturers in the jurisdiction will implement UDI by the end of November
.
In addition, many provinces and cities have expanded the scope of implementation in accordance with the requirements of the "Announcement on Deepening the Pilot Program and Doing a Good Job in the First Batch of Implementation of the Unique Identification of Medical Devices" and combined with local actual conditions.
Fujian, Yunnan, Hainan, Tianjin and other provinces and cities Include the second category of medical devices in the implementation varieties
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With the continuous expansion of the scope of UDI implementation and the continuous advancement of work in various regions, it will help strengthen the life cycle management of medical devices in China, improve the accuracy and consistency of medical device identification, improve the level and efficiency of medical device management, and effectively protect the safety of the public Effective
.