The NMPA, together with National Health Commission and National Healthcare Security Administration, issued the “Advancing UDI Implementation for Subsequent Device Categories” and “UDI Implementation under Specific Circumstances” on March 13, 2026. These two policies expand UDI coverage, refine technical requirements, and introduce targeted exemptions, marking a significant step toward full lifecycle traceability of medical devices in China.
As a legal representative in China, China Med Device, LLC assists foreign medical device companies with the full UDI process, including registration, assignment of UDIs to the smallest sales units, submission of product data to the national UDI database, and ensuring alignment with medical insurance coding requirements. The company also advises on exemption eligibility, coordinates with local authorities, and provides guidance on label design, database updates, and traceability compliance, helping overseas manufacturers efficiently meet China’s regulatory obligations while minimizing delays in market access. info@ChinaMedDevice.com
UDI for Class II Devices started on June 1, 2024. Click HERE for more information
For our recorded webinar on “Labeling and IFU – Enhanced Requirements of Post Market Surveillance Per Order 739”, click HERE
Expanding UDI Scope and Implementation Timeline
The first announcement expands UDI coverage to all remaining Class II medical devices and Class I IVDs from June 1, 2027, and to all Class I devices from June 1, 2029. Products made before these dates are exempt, providing a transition period for manufacturers.
Key scope and timeline highlights include:
- All Class II devices and Class I IVDs must bear UDI if manufactured on or after June 1, 2027
- All Class I medical devices must bear UDI if manufactured on or after June 1, 2029
- Products manufactured before the respective dates are not required to comply
- The policy builds on three previous implementation batches (2020, 2021, 2023)
The document also clarifies how UDI integrates into regulatory processes. For applications submitted after the implementation dates, the UDI for the smallest sales unit must be included in the registration or filing system. For already approved products, submission will be required during renewal or change procedures. Notably, changes limited to product identifiers do not constitute regulatory variations, reducing administrative burden.
Regulatory submission requirements can be summarized as follows:
- New registrations/filings must include UDI for the smallest sales unit
- Existing products must submit UDI during renewal or change applications
- Product identifier updates alone do not trigger regulatory variation
- UDI is not a technical review item in registration evaluation
A key requirement is the submission of UDI data to the national database prior to commercialization. Manufacturers must upload identifiers for both the smallest sales units and higher-level packaging, ensuring data accuracy, completeness, and traceability. In addition, devices listed in reimbursement systems must maintain consistency between UDI data and medical insurance coding databases.
UDI database obligations include:
- Mandatory data upload before market launch
- Coverage of both smallest sales unit and higher-level packaging
- Ensuring data is accurate, complete, and traceable
- Synchronization with medical insurance coding databases where applicable
- Timely updates when product identifier information changes
The announcement also emphasizes coordinated responsibilities across the supply chain:
- Manufacturers must establish UDI-based traceability systems to support recalls and adverse event monitoring
- Distributors are required to implement UDI-based inbound/outbound management and data upload
- Healthcare institutions must integrate UDI into clinical use, billing, and reporting processes
- Authorities are responsible for system integration and cross-sector coordination
Exemptions and Special Scenarios
The second announcement introduces exemptions and special scenarios. Devices in multi-unit packages (e.g., masks), customized devices, transport packaging, export-only products, and certain drug-device combinations may be exempt from UDI or rely on existing drug traceability systems.
Key exemption scenarios include:
- Single-use devices within multi-unit packages (if outer package has UDI)
- Customized medical devices
- Transport-level packaging
- Export-only products (subject to destination country requirements)
- Certain drug-device combination products
At the same time, tailored requirements are introduced for specific product types:
- Reusable devices should adopt direct marking where feasible; otherwise, alternative traceability solutions are acceptable
- Class I reusable surgical instruments may only require UDI-DI (not UDI-PI)
- Standalone software may present UDI digitally via interface or API, without a physical carrier
Key Considerations for Overseas Medical Device Manufacturers
For overseas manufacturers, these updates require proactive planning and localization. Companies should first assess their product classifications and align with the 2027 (Class II) and 2029 (Class I) implementation timelines, ensuring sufficient lead time for UDI assignment, labeling updates, and system readiness.
Key considerations include:
- Map product portfolios to China classification and confirm applicable deadlines
- Plan early for UDI assignment, packaging updates, and IT system readiness
- Align global UDI standards (e.g., GS1, HIBCC) with China-specific database requirements
- Ensure consistency between UDI data and medical insurance coding systems where relevant
- Evaluate eligibility for exemptions (e.g., export-only or customized devices)
- Consider voluntary UDI adoption even where exemptions apply for global consistency
- Establish strong coordination with local agents for data submission and maintenance
- Invest in data governance and digital infrastructure to support lifecycle compliance
As China’s regulatory system becomes increasingly data-driven, UDI compliance should be viewed not only as a regulatory requirement but also as a strategic capability for sustainable market access and operational efficiency.