NMPA Expands Unique Device Identification (UDI) System Coverage

China’s National Medical Products Administration (NMPA) released two draft announcements for public consultation on September 25, 2025, outlining plans to expand the Unique Device Identification (UDI) system to nearly all classes of medical devices.

This proposed expansion marks a significant step in China’s ongoing effort to enhance post-market surveillance, traceability, and regulatory transparency within the medical device sector.

Strengthening Device Traceability and Patient Safety

The UDI system is designed to assign a globally unique code to every medical device model, allowing authorities, healthcare providers, and patients to track devices throughout their lifecycle from production and distribution to clinical use and post-market monitoring.

Under this latest draft, the NMPA plans to extend UDI requirements beyond high-risk (Class III) and certain Class II devices to include almost all Class II and Class I devices. This move reinforces China’s commitment to aligning with international best practices in device identification and safety management.

Phased Implementation Timeline

According to the draft announcements, the expanded UDI system will be implemented in phases:

• From 1 June 2027: UDI requirements will apply to Class II and certain Class IV devices.

• From 1 June 2029: The scope will extend to remaining Class I devices, completing full national coverage.

Manufacturers will be required to assign and register UDIs before market entry, ensuring data accuracy and consistency within the NMPA’s UDI database.

Implications for the MedTech Industry

This expansion carries major implications for local and foreign manufacturers:

• Regulatory Readiness: Companies must ensure that their labelling systems, packaging lines, and regulatory submissions comply with UDI format and database requirements.

• Data Integrity: Accurate reporting of UDI information to the NMPA database will be critical for successful product registration and market access.

• Post-Market Surveillance: Authorities will have improved capabilities to monitor product safety, manage recalls, and trace defective batches efficiently.

The NMPA’s move underscores a broader global trend where traceability is becoming a central pillar of regulatory compliance, improving both accountability and patient safety.

Call for Public Comment

Stakeholders are encouraged to review and submit feedback during the public consultation period, open until 26 October 2025. Comments can be sent directly to the NMPA through the designated channels provided in the draft announcements.

This development reflects China’s strategic focus on modernising its medical device regulation system strengthening quality control, ensuring transparency, and paving the way for greater international harmonisation.

Source:

National Medical Products Administration (NMPA), China; Draft Announcements on the Expansion of the Unique Device Identification (UDI) System (Published 25 September 2025)