What is UDI: Unique Device Identification medical device unique identification

The understanding of the vernacular: and human ID card ID, but UDI is the device ‘ID’.
Explanation of terminology: It refers to the medical device products or packaging attached to the
code composed of numbers, letters or symbols, used to identify the uniqueness of medical
devices.

The UDI is composed of two parts: DI + PI

DI: Indicator G1 + Manufacturer's Identifier + Product Code + Check Bit
Indicator:

G1 is the packaging indicator, taking the value 0~8, 0 represents the device itself or the label, 1-8
represents the packaging, and so on.

Vendor identification code is GSI assigned to the vendor identification code, applied by the
vendor itself, the code domestic are 69 beginning.
Product code is generally in accordance with the company's internal coding rules, the company's
own allocation.

Check digit is in the GSI system, GSI automatically generated in accordance with the coding rules

PI:Production identification code consists of the code of the information related to the
production process of medical devices, according to the regulatory and practical application
requirements, it can contain the serial number of medical devices, production batch number,
date of production, expiration date and so on.
PI is shown in red below
The role of UDI:

UDI Regulations:
China: rules on unique marking system for medical devices (No. 66 of 2019)
Announcement on Deepening the Pilot to Do a Good Job in the First Batch of Implementing
Unique Identification of Medical Devices (No. 106 of 2020)
Announcement on Doing a Good Job in the Second Batch of Implementing Unique Identification
of Medical Devices (No. 114 of 2021)
EU:
MDR-EU-2017/745 Article 27~28, ANNEX VI

US:
CFR 820.30 UNIQUE DEVICE IDENTIFICATION

Components of a UDI system: code + carrier + database

UDI is similar to our ID card, after applying the UDI code, we need to circulate it, so we need to
file the UDI in the database.
What about the carrier?
There are three kinds of carriers for UDI: 1D barcode

2D barcode

RF label
The choice of carrier:
Summarising the UDI process: requesting and obtaining a vendor code
Prepare UDI-DI
Prepare UDI-PI
Produce UDI 1D, 2D barcode or RFID tag
Database declaration