China’s UDI System: What International Medical Device Manufacturers Must Know

The China Unique Device Identification (UDI) system has become a central pillar of the country’s medical device regulatory framework, ensuring full lifecycle traceability through standardized device identification codes.

China formally established the legal foundation for the system with the issuance of the Rules for the Unique Device Identification System in 2019, which defined the structure of the UDI framework and national database. However, mandatory implementation began later through phased rollout measures, gradually expanding coverage from high-risk implantable products to broader device categories.

Continue below for the full explainer, or get in touch with Cisema for assistance with China UDI compliance and medical device registration support.

Today, the framework is no longer limited to a narrow group of high-risk products. Following the third implementation phase and the regulatory announcements issued in 2026, China has now established a clear roadmap for extending UDI requirements to nearly all medical devices. For overseas manufacturers, this means UDI is no longer a niche compliance topic but an increasingly important part of market access, labeling, data governance, and long-term regulatory planning in China.

With that context in place, the first step is to understand what the China UDI system is designed to do and why regulators have made it such a central part of medical device oversight.

What Is the China UDI System for Medical Devices?

The China UDI system is a regulatory mechanism designed to ensure that each medical device can be accurately identified and traced throughout its lifecycle, from manufacturing and distribution to clinical use and post-market monitoring.

Under this system, each medical device receives a standardized identification code that allows regulators, healthcare providers, and manufacturers to access key information about the product’s origin, production details, and regulatory status.

Although the system was legally established in 2019, China introduced UDI requirements gradually through a phased implementation strategy. Regulators initially focused on higher-risk medical devices where traceability is most critical before expanding the scope to additional product categories.

Overall, the development of China’s UDI framework aligns with global regulatory trends, including similar traceability initiatives implemented by the U.S. FDA and the European Union through the EUDAMED system.

How the China UDI System Has Expanded

China introduced the UDI framework through a phased implementation strategy, allowing regulators and manufacturers to gradually adapt to the new traceability requirements while expanding coverage across device categories.

Phase 1: UDI for High-Risk Class III Medical Devices

Mandatory UDI implementation began on January 1, 2021, focusing on high-risk Class III medical devices, particularly products where traceability is essential for patient safety.

Examples included:

• Implantable cardiac devices
• Orthopedic implants
• High-value implantable consumables

Phase 2: Expansion to Additional Class III Devices and Surgical Equipment

The second phase took effect on June 1, 2022, expanding UDI requirements to additional Class III medical devices, including certain high-risk active and passive surgical instruments.

This stage further strengthened traceability within hospital environments and ensured that critical devices used during procedures could be accurately tracked throughout their lifecycle.

Phase 3: Inclusion of Additional Device Categories Including Class II Products

The third phase took effect on June 1, 2024 and significantly broadened the scope of the China UDI system. This stage added 103 new device types across 15 major product categories, including:

• Orthopedic devices
• Cardiovascular devices
• Respiratory anesthesia equipment
• Ultrasonic surgical accessories
• Surgical staplers

This phase was particularly important because it brought certain Class II medical devices into the UDI framework for the first time. In other words, the system moved beyond its earlier focus on the highest-risk devices and began to cover a wider portion of the market.

That shift set the stage for the next major development: a confirmed roadmap for broader implementation across Class II and Class I devices.

Confirmed Future Implementation Phases

China’s 2026 regulatory announcements confirmed the next steps in expanding the UDI system to cover additional device categories.

Under Announcement No. 21 of 2026, UDI requirements will be extended based on device classification and manufacturing date.

From June 1, 2027

The following products must carry a UDI:

• All Class II medical devices, including IVD reagents
• All Class I IVD reagents

From June 1, 2029

The requirement will then expand to:

• All remaining Class I medical devices

Importantly, compliance is determined based on the manufacturing date rather than the import date. Devices manufactured before the applicable deadline may continue to be marketed without retroactive UDI labeling.

This approach makes the expansion more practical for manufacturers and importers, while still moving China toward near-universal device traceability.

China UDI Requirements

China applies the UDI framework to imported and domestic medical devices on equal terms. For overseas manufacturers, that means compliance is not optional or secondary. Any product placed on the Chinese market must meet the same UDI-related obligations that apply to locally manufactured devices.

For international companies, key compliance requirements generally include:

• UDI labeling on product packaging and labeling materials
• Submission of product information to the official UDI database
• Alignment of device data relevant systems

UDI compliance therefore extends beyond labeling alone. Manufacturers must ensure that their internal regulatory, quality, and supply chain processes support ongoing data management and system integration.

Special Situations and Exemptions

As China expanded the UDI framework, regulators also clarified several situations in which UDI requirements may be modified or exempted through Announcement No. 15 of 2026, which clarifies several situations in which UDI requirements may be modified or exempted.

Examples of exempt or modified scenarios include:

• Individual single-use devices within a labeled pack (such as masks, blood collection tubes, or condoms)
• Customized medical devices produced for individual patients
• Transport packaging
• Drug-device combination products primarily regulated as pharmaceuticals
• Devices manufactured exclusively for export

In addition to these exemptions, the announcements introduced tailored rules for certain product types.

Reusable devices should, where technically feasible, carry a direct UDI marking on the device itself. If direct marking is not possible, alternative traceability measures may be acceptable. For Class I reusable surgical instruments, only the UDI-DI is required, which simplifies implementation. Additionally, for standalone software, the UDI may be displayed electronically rather than through a physical carrier.

These clarifications are important because they show that China’s system is expanding not only in scope, but also in operational detail. That makes early planning even more important for companies with varied product portfolios and multiple packaging formats.

Operational Considerations for International Medical Device Manufacturers

Although the regulatory requirements apply equally to all products, international manufacturers often encounter additional operational challenges when implementing China’s UDI requirements.

Understanding these challenges early helps companies design more effective compliance strategies.

Localization Adaptation

Label information must comply with Chinese language requirements, and the UDI carrier must remain clearly readable after transportation and storage.

This often requires coordination across several teams, including:

• Packaging design
• Regulatory affairs
• Translation and labeling review
• Supply chain operations

For companies using global labeling templates, China-specific adjustments may be needed to accommodate both local language requirements and local packaging hierarchy expectations.

Integration with the Medical Insurance System

China increasingly links product identification data with hospital procurement platforms, reimbursement systems, and medical insurance databases. As a result, UDI is becoming part of a broader healthcare digitalization framework rather than a stand-alone regulatory code.

Manufacturers should therefore ensure that product information remains consistent across:

• Registration or filing records
• UDI database entries
• Medical insurance classification systems
• Procurement and distribution records

This consistency matters not only for compliance, but also for downstream commercial access.

Ongoing Regulatory Monitoring

China’s UDI framework continues to evolve as regulators refine technical standards, enforcement mechanisms, and device catalogues.

International companies are therefore recommended to establish a dedicated team or leverage local partners to continuously monitor policy changes.

With these operational points in mind, UDI becomes easier to understand as a business-critical compliance function rather than a narrow coding exercise.

Final Thoughts: From Access to Compliance Strategy

The China UDI system represents a major step toward comprehensive medical device traceability across the country’s healthcare ecosystem. With confirmed expansion to all Class II devices by 2027 and all Class I devices by 2029, UDI compliance is becoming an increasingly important element of regulatory strategy for companies operating in China.

For international manufacturers, integrating UDI into product lifecycle management, labeling processes, and regulatory data systems can significantly reduce compliance risks while supporting smoother participation in hospital procurement and reimbursement programs.

Early preparation will help companies adapt to the upcoming implementation milestones and ensure stable market access as China continues strengthening digital oversight of the medical device sector.

For companies seeking support with UDI planning, database submission, or labeling requirements for Class I and Class II medical devices and IVDs in China, get in touch with Cisema today for regulatory guidance and practical assistance throughout the implementation process.

Further Information

If you are an international medical device manufacturer with questions about how the new UDI regulations impact your product registration in China or require support for UDI solutions in China, get in touch with Cisema for expert guidance and support.

Read related news:

• China UDI medical device third batch – implementation date released
• China UDI requirements for third batch of medical devices
• UDI Soon Required for All Class III Medical Devices and IVDs

FAQs: China's UDI System

As companies move from understanding the regulatory framework to implementing practical compliance measures, several operational questions frequently arise. The following answers address common concerns from international medical device manufacturers navigating China’s UDI requirements.

Is China’s UDI System Compatible With International Standards?‍

Yes. China’s UDI framework adopts a Device Identifier (DI) + Production Identifier (PI) structure, which aligns with internationally recognized coding systems such as the GS1 standard.

How Should Manufacturers Address Coding for Multi-Level Packaging?

China requires that the smallest sales unit of a medical device carry a UDI code. Acceptable carriers include:

• Barcodes
• QR codes
• RFID tags

If physical space on the packaging is limited, companies may request special arrangements. However, such situations must be communicated with the regulatory authorities in advance to ensure compliance.

Do products that are not in the first, second or third batch of the UDI catalog need to be prepared in advance?

Although China’s UDI system has been implemented in phases, regulators encourage companies to voluntarily expand UDI implementation beyond the currently required product categories.

Early adoption is particularly beneficial for devices that plan to:

• Enter the medical insurance reimbursement catalog
• Participate in volume-based centralized procurement programs

By implementing UDI ahead of mandatory deadlines, manufacturers can improve operational readiness and strengthen their competitiveness within China’s increasingly digital healthcare ecosystem.

References

• Read the original announcement for China’s Unique Device Identification UDI system regulatory updates.