China will expand its Unique Device Identifier (UDI) requirements to cover a wider range of medical devices. Under the updated framework that will go into effect on June 1, 2027, all Class II medical devices, including in vitro diagnostic (IVD) reagents, and all Class I IVD reagents must bear a UDI. Products manufactured before the implementation date will be exempt from this requirement.
The policy also introduces stricter rules for submitting Product Identifiers (UDI-DIs). For applications submitted on or after the implementation date, applicants must include the Product Identifier for the product’s minimum sales unit. Minimum sales unit is the smallest container or package level that is sold. For products already approved or filed before the deadline, Product Identifiers must be submitted during renewal and change registration.
In addition, registrants must upload Product Identifiers for both minimum sales units and higher-level packaging to China’s UDI database (UDID) before market launch to ensure that all data are accurate, complete, and traceable. Companies will also be required to align UDI data with existing medical insurance classification and coding systems maintained by the National Healthcare Security Administration (NHSA).
Any changes to Product Identifier data must be reflected in the UDID before market release. If the Product Identifier itself changes, this information must be updated in the UDID as soon as possible. The expanded UDI requirements are expected to strengthen traceability and data consistency across China’s medical device regulatory and reimbursement systems.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.