Unique Device Identification (UDI) for China

China has also introduced “UDI” for medical devices. Medical devices have to be labeled in accordance with Chinese regulations, and they must also be registered in the NMPA database of the Chinese Ministry of Health. UDI is already mandatory for Class III medical devices, followed by Class II Mds in February 2027, and then Class I Mds follow.

The accredited coding systems for UDI conforming product labeling in China are

• the GS1 system
• the MA Coding System from ZIIOT
• the coding system from ALIBABA

While the GS1 system uses the standard numeric GTINs of the EAN code, the MA Coding System allows for the encoding of alphanumeric product codes of up to 18 characters plus 1 digit package index, compatible with the product codes in an HIBC (HIBC is not accredited for use in China.). The ALIBABA system assigns ALIBABA-specific number ranges to manufacturers’ products.

HIBC user

For manufacturers who use the “Health Industry Barcode (HIBC)” for the U.S., Europe, Turkey, etc., the MA Coding System bridges the gap to China, as the same product data can be used as in HIBC. Given product numbers simply can be supplemented with the MA-specific company ID and transferred in the MA coding format. For HIBC users, this means minimal effort is required for printing of UDI codes for China. Additionally, the HIBC user can scan an existing HIBC and print an MA code that complies with Chinese regulations offline. Even this can be an offline process.

Tools for MA UDI implementation and also verification software for quality management are available from www.elmicron.de.

EDCi offers free information on generating the MA code and how to optain a Company ID that is valid in China. See also https://www.e-d-c.info/en/udi-2/#ma-udi.