Exemptions depend on specific conditions and do not waive device registration or filing
Where the special-case rules apply
NMPA Announcement No. 15 of 2026 clarifies seven UDI exemption categories and special identification arrangements for reusable devices and standalone software. The document was signed on January 23 and posted on the official UDI system on March 13. An exemption from UDI implementation covers identifier creation, coding and database submission under the UDI system rules. It does not exempt a product from medical device registration or filing. Eligibility depends on the packaging configuration, intended use and applicable traceability conditions, rather than the product name alone.
Packaging and use-based exemptions are conditional
The categories include qualifying individual single-use devices within a labeled sales unit, custom-made devices, certain single-use components in procedure packs, transport packaging, export-only devices and specified drug-device or co-packaged products with drug traceability. The individual-unit exemption for identical single-use devices requires the smallest sales unit to carry UDI and excludes implants with classification codes 12-XX or 13-XX. Export-only devices remain subject to the destination country's requirements.
Reusable devices and software have distinct identification methods
Reusable devices requiring reprocessing before each use generally need direct marking. If direct marking would affect safety or effectiveness, or is technically impracticable, the smallest sales-unit packaging must carry UDI and an alternative effective identification and traceability solution must be provided. Class I reusable surgical instruments may omit the production identifier but must retain the device identifier. Standalone software supplied without physical media must display UDI in readable plain text; software without a user interface must transmit it through an API.
Existing public database records remain public
Eligible companies may choose to implement UDI voluntarily or discontinue implementation where the exemption applies. Previously published product information remains public in the UDI database. Regulix recommends documenting the eligibility assessment and traceability arrangements without treating an identification exemption as relief from other compliance obligations.
