Does GS1 meet UDI regulations in other countries?

2026-01-09 Click： 18

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Questions about UDI for medical devices:

Can medical devices produced by domestic companies and sold directly in China (including imported and repackaged in China) use the barcode of the product of overseas brand owners as UDI?

Answer: First of all, it should be confirmed that the main body applying for the GS1 manufacturer code is the "registrant/registrant", and that the product barcode meets the requirements of relevant domestic regulations, and then it can be used after filing overseas codes in the coding center. For details, please refer to the "Registration Notice on Using Overseas Registered Commodity Barcodes".

Does GS1 meet UDI regulations in other countries? Can the manufacturer identification code applied from the China Article Numbering Center be used for UDI of export products?

Answer: GS1 is a UDI issuing agency recognized by the United States and the European Union, and it also meets the relevant UDI regulations issued by countries around the world. The manufacturer identification code assigned by the coding center can be used to compile UDI that complies with foreign regulations.

Can the manufacturer identification code applied by a group company be used for UDI of products produced by subsidiaries?

Answer: On the premise of meeting drug supervision regulations, in accordance with the "About<商品条码管理办法>Letter of Opinions on Relevant Issues during the Implementation Process "(Quality Inspection Measures Letter [2008] No. 67), issues related to the use of commodity barcodes by subsidiaries of the group company:

(1) For products independently developed, designed and produced by the subsidiary, the subsidiary shall use the manufacturer identification code and the corresponding product barcode that the subsidiary has applied for registration.

(2) After filing by China Article Coding Center, subsidiaries can use the UDI of GS1 standard to automatically manage medical devices when the group company uniformly develops, designs, and arranges production and circulation enterprises, medical institutions and other units?

Answer: In terms of hardware, it should be confirmed whether the scanning equipment can accurately read UDI information in various GS1 barcodes according to the GS1 standard. Common GS1 barcodes include EAN/UPC, ITF-14, GS1-128, and GS1 DataMatrix, etc. Among them, EAN/UPC and ITF-14 are applicable when UDI only contains DI.

In terms of software, it should be confirmed whether the system has a 14-bit field used to store GTIN at each relevant product packaging level (when GTIN is less than 14 digits, zeroes should be added in front to 14 digits), and whether the system can verify the GTIN and related information in the barcode. Accuracy, whether it has the function of associating serial number, production batch number, production date, and expiration date information to GTIN and storing it.

Where can I find GS1-related national standards?

Answer: You can inquire online through the national standard full-text disclosure system.商品条码管理办法>