New phases cover remaining Class II devices, Class I IVDs and other Class I devices
The next UDI milestones are set
China's medical products, health and healthcare security authorities have issued Announcement No. 21 of 2026 on unique device identification for additional medical device categories. Signed on March 4 and posted on the official UDI system on March 13, the announcement addresses categories outside the three earlier implementation batches. All Class II devices, including in vitro diagnostics, and all Class I IVDs manufactured from June 1, 2027 must carry UDI. All Class I devices manufactured from June 1, 2029 must carry UDI. The announcement also establishes how device identifiers enter registration and filing systems, making this more than a packaging exercise. Companies need coordinated plans for coding, regulatory submissions and database maintenance.
Submit identifiers through registration and filing systems
Applications submitted from the relevant implementation date must include the device identifier for the smallest sales unit. Previously accepted or approved registered products submit it at renewal or change registration; previously filed products submit it when amending the filing. The identifier is not a registration or filing review item, and an identifier change alone does not constitute a registration or filing change.
Upload and maintain data before placing products on the market
The relevant identifiers and data for the smallest sales unit and higher packaging levels must be uploaded to the UDI database before market placement. Products with healthcare reimbursement classification and code records must also complete the corresponding fields and keep the systems consistent. Changes to associated data require updates before sale; a changed device identifier is uploaded as a new identifier.
Check earlier batches and applicable exemptions
The transition for products manufactured before the new milestones does not displace requirements already applicable under earlier implementation batches. Qualifying exemptions under Announcement No. 15 of 2026 remain relevant. Regulix recommends mapping each product's classification, manufacturing date and existing UDI obligations before setting submission and data-maintenance schedules.
