China FDA Releases Draft Guidance on UDIs

China’s Food and Drug Administration asked for additional feedback on its draft guidance covering its unique device identification system.

The CFDA wants to strengthen the supervision and management of medical devices sold in the country. It plans to use the international GS1 standard and will likely introduce a separate national standard, according to consultancy Global Regulatory Partners. The CFDA may act as the issuing agency for the national code.

China is taking a similar approach to that of the U.S. FDA for its UDI database. It plans on using a global medical device nomenclature (GMDN) and a national nomenclature. The China Medical Device Nomenclature (CMDN) has already assigned codes to about 20 percent of domestic devices.