According to Announcement No. 21 (2026) jointly issued by the National Medical Products Administration (NMPA), the National Health Commission, and the National Healthcare Security Administration, the implementation of UDI for medical devices has entered a full coverage phase:

For all Class II medical devices and all Class I in vitro diagnostic reagents produced on or after June 1, 2027, registrants and filing holders must upload product identifiers and related data to the UDI Database before market release, ensuring data is authentic, accurate, complete, and traceable.

1. Coding & Labeling Layer — Compliance Starts at the Source

Key Advantages:

· Native GS1 Standard Support: Nearly 94% of Chinese medical device manufacturers choose GS1 barcodes as their UDI standard. The Linkwin suite is built on GS1 standards, ensuring international coding compatibility.

· Automated DI Coding: Built-in compliance validation ensures codes meet NMPA requirements, eliminating manual coding errors that lead to submission rejection.

· Extreme Environment Adaptation: Provides specialized label material solutions for various sterilization methods (autoclaving, ethylene oxide, irradiation, etc.) and usage environments.

2. Data Submission Layer — Seamless NMPA Database Integration

Technical Highlights:

· Developed using RESTful API technology, submitting requests via HTTPS POST with JSON string parameters — fully aligned with national UDI Management Information System standards.

· Supports enterprise system integration with the NMPA database via API, enabling data submission, maintenance, and shared query functionality.

· Establishes a regular data synchronization mechanism to download the latest product classification catalog, coding rules, and regulatory policies from the national UDID in real-time or on schedule, keeping the local UDI application system synchronized with national UDID updates.

3. Traceability Application Layer — Full Lifecycle Closed Loop

Key Capabilities:

· Precision Product Recall: Rapidly locate affected batch distribution via UDI, narrowing recall scope to specific batches or even individual units.

· Adverse Event Monitoring: UDI links production, distribution, and usage data across the entire chain, providing a complete evidence chain for adverse event analysis.

· Near-Expiry Alert: Automatically triggers near-expiry warnings, certificate expiration alerts, and non-conforming product recall notifications for medical devices.

4. Global Collaboration Layer — One System, Multi-Country Compliance

Key Advantages:

· Built on the GS1 standard,framework, UDI codes simultaneously meet regulatory requirements in China (NMPA), the United States (FDA), and the European Union (MDR) and other jurisdictions

· Helps enterprises meet domestic and international medical device compliance requirements, effectively addressing technical trade barriers in Europe and America, proactively aligning with international standards, and reducing export risks.