UDI code implementation plan for unique identification of medical devices

In order to achieve the purpose of product anti-counterfeiting, flow tracking, product traceability, precise calling and reducing the occurrence of medical accidents, the State Food and Drug Administration issued an announcement showing that after the pilot, The implementation of the first batch of unique identification for medical devices will be fully launched, and the implementation time of the first batch will be adjusted from October 1, 2020 to January 1, 2021. Based on this policy background, as one of the major domestic manufacturers of high-resolution cij printers, the logo has developed a complete set of unique UDI codes for medical device identification for the medical device industry.

UDI code encoding rules

The unique identification of medical devices is composed of product identification (DI) and production identification (PI). The product identification (DI) is a unique code to identify the registrant/filer, the model specification and packaging of the medical device. It is a 'keyword' for obtaining medical device-related information from the database, and is a necessary part of the unique identification; the production identification (PI) includes Information related to the production process, including product batch number, serial number, production date, and expiration date, can be used in conjunction with product identification to meet the needs of fine identification and recording of medical device circulation and use.

The UDI compilation structure based on the GS1 standard includes the static information DI of the device identification and the dynamic information PI of the production identification. Among them, DI includes the global trade item code GTIN, which specifically includes packaging indicator, manufacturer identification code, commodity item code, check code, etc. PI specifically includes application identifier, expiration date, serial number, production date, etc.

Due to the different risks of medical device use and regulatory traceability requirements, the unique identification of the device will also change accordingly. UDI can be represented by DI alone or in combination with DI plus PI. According to different medical device products, specifications, models, batches, and single products can be identified.

The entire implementation process of UDI code assignment

1. Docking registration application: Log in to the national UDI data platform (https:/ /udi.nmpa.gov.cn/), complete the docking registration application according to the guidelines;

2, select the code issuing agency: medical device registration/recording person, select qualified Code issuing agency;

3, UDI code application: medical device registration/filing person, complete UDI code application according to the code issuing agency’s guidelines;

4. UDI identification code: medical device registration/recording person uses coding equipment to code the product and assign it a unique identity;

5. UDI product traceability: UDI code is used for traceability management, which is conducive to the monitoring of adverse events and the recall of problem products, improving medical quality and ensuring patient safety.

Reminder: Each industrial control platform will generate a different UDI code. All product UDI codes are generated on-site and uploaded to the UDI traceability background by the on-site industrial control platform.

UDI code assignment detection and removal system

Medical Device UDI coding inspection (removal) process: product incoming material-industrial control platform output barcode-cij printer executes coding-barcode scanning-data collection comparison-trigger rejection or pass-shunt or reject execution- Entering the packing station-manual sealing and warehousing

Benefits of implementing UDI for medical devices

1, can be simplified The operation of integrating device usage information into the data system;

2, can quickly identify medical devices with adverse events;

3. It can formulate corresponding solutions for the reported problems more quickly;

4. It can reduce the occurrence of medical accidents;

5. Provide faster and more effective device recall data;

6. Realize key and effective safety communication with drug regulatory authorities;

7. You can easily access the original source of accurate device identification information.

The unique identification of medical devices has a meaning to realize the integration and sharing of regulatory data, innovate regulatory models, improve regulatory effectiveness, strengthen medical device life-cycle management, purify the market, and optimize operations. Business environment, realizing the combination of government supervision and social governance. The high-resolution UV cij printer can print all kinds of variable data in real time, including bar codes, two-dimensional codes, date and time, counters, LOGO, graphics, tables, databases, etc. According to different packaging materials and product characteristics, a supporting system is developed UV inks with a wide range of material adaptability can fully meet the printing needs of permeable and non-permeable materials, and effectively improve the quality of encoded data to meet the specified requirements.

It isn't just about being on cij printer anymore–it's about maximizing the potential of the platform of manufacturing.

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