One instrument, one code, a unified traceability system has been established nationwide by means of unique device identification (UDI), which is equivalent to any medical device having a unique "ID card"! Medical devices from production, processing to circulation, distribution, use of the whole process can be traced, the whole process supervision era is really coming!

The UDI system pilot will begin

Recently, the State Food and Drug Administration held a medical device unique identification system pilot work seminar to discuss the "Medical device unique identification system pilot work program" (hereinafter referred to as the "Program").

Giving unique identification to medical device products is an international practice and has been called for many years in China. The workshop was certainly an important step forward. The participants also said that they support the implementation of unique identification of medical devices and jointly promote China's medical device industry to be in line with international standards.

Hu Yongmei, executive vice president of the Medical Device Research Institute of Sinopharm Group, pointed out that the introduction of UDI in medical device products helps logistics enterprises reduce the error rate and improve work efficiency.

What is UDI

Unique Device Identification (UDI) is a "special medical device identification system" established by the United States FDA, which is the identity identification given to medical devices in their entire life cycle, and is the only "ID card" in the product supply chain.

The UDI consists of a device identification number (DI) and a manufacturing identification number (PI). Device identification DI is static information. It is the identification of medical device products in the supply chain and can be used as a "keyword" to query the basic information of the product traceability in the database.

Production identification PI belongs to dynamic information, which includes the serial number, batch number, production date and expiration date of medical device products, etc. It is the dynamic additional information of medical device products, and it can be used in combination with DI to point to a specific medical device product.

Big move by the FDA! The era of the most stringent traceability supervision of medical devices is coming! (Figure 1)

Earlier, the State Administration for Market issued the Rules for the Unique Identification System for Medical Devices (Draft for Comment), clarifying that the State Drug Administration is responsible for establishing the unique identification system for medical devices, formulating and issuing the implementation plan for the unique identification system for medical devices, and promoting the active application of unique identification for medical devices management to achieve data interconnection.

It means that all medical device companies in the country have to implement it. In addition, the State Drug Administration has formulated relevant standards and norms for the unique identification data of medical devices, and organized the establishment of a unique identification database of medical devices for public inquiry.

It means that the unique identification database of medical devices is to be publicized to the whole country, and all links and information have data to follow and can be checked. The national implementation conditions of unique device identification are mature, and international standards will be realized.