UDI in China: Most Medical Devices Now Covered Under the Latest NMPA Drafts

On 25 September 2025, the National Medical Products Administration (NMPA) released two draft announcements for public consultation:

“Announcement on the Implementation of Unique Device Identification (UDI) for Medical Devices under Specific Circumstances (Draft for Comments)”
“Announcement on the Continued Implementation of UDI for Subsequent Categories of Medical Devices (Draft for Comments).”

These drafts propose an expansion of China’s Unique Device Identification (UDI) system to cover nearly all medical devices marketed in China, while also clarifying requirements for special cases that fall outside the framework.

The consultation period runs until 26 October 2025 – contact Cisema for expert support in understanding the proposed changes and preparing your feedback.

Scope of Implementation

The latest proposals would expand China’s UDI framework to cover nearly all medical devices on the market, following a phased implementation schedule:

Already implemented – all Class III devices and certain Class II devices
From 1 June 2027 – all Class II medical devices (including in vitro diagnostic reagents) and Class I in vitro diagnostic reagents must carry a UDI
From 1 June 2029 – all remaining Class I devices must be included

Notably, compliance will be based on the production date, not the import date. This approach allows products manufactured before the effective date to remain in circulation without needing retroactive UDI marking.

Exemptions and Special Cases

To support practical implementation of the UDI system, the NMPA has identified specific product categories and situations where coding requirements may be simplified or waived.

The following products and scenarios are proposed for exemption:

Multi-pack items already coded at the smallest unit level (for example, condoms or masks)
Custom-made devices manufactured for individual patients
Disposable accessories included in a coded combination pack, provided the pack itself bears a UDI
Transport packaging and export-only products
Drug-device combination products where the drug is the traceable main component.

In addition, reusable medical devices are recognised as a special case under the draft proposals. Given the technical challenges of applying permanent markings to certain devices, the NMPA has outlined a more flexible approach:

Where technically feasible, the UDI must be marked directly on the device.
If direct marking is not possible, labelling on packaging or a label is acceptable if supported by a documented traceability plan.
For Class I reusable surgical instruments, only the UDI-DI is required.

Compliance Obligations for Manufacturers

To comply with the proposed UDI requirements, manufacturers will need to take several actions:

Assign UDI-DI and UDI-PI at the smallest sales unit and all higher packaging levels.
Report UDI-DI data during registration, renewal, or modification through the NMPA registration or filing management system.
Upload UDI-related data to the national UDI database prior to market launch and ensure synchronisation with the medical insurance consumables coding system.

Key Considerations for Foreign Manufacturers

While many global manufacturers already use UDIs in other markets, adapting these systems to meet China’s regulatory framework will require additional planning and coordination.

Foreign manufacturers should consider the following:

Selecting a Coding Agency

Choosing an NMPA-recognised issuing agency is the first step towards assigning UDIs for products to be marketed in China. NMPA-recognised issuing agencies include:

The China Item Coding Center (GS1 China)（中国物品编码中心）
The Zhongguancun Industry and Information Two-Dimensional Code Technology Institute (MA) （中关村工信二维码技术研究院）

Companies using a GS1 global prefix should confirm that their data fields align with China’s UDI database interface. Those using other coding systems may need to assess the cost and complexity of conversion to ensure seamless data integration.

Adapting Multi-Level Packaging to a Parent-Child Linkage Structure

Each packaging level — from the smallest sales unit to the outermost carton — must carry its own UDI and maintain a clear parent–child linkage structure. Manufacturers currently applying a “single-code-for-all-levels” approach in other markets will need to redesign their packaging hierarchy for China to prevent database conflicts and maintain full traceability.

Coordinating with Domestic Agents for UDI Compliance

Domestic agents will have expanded responsibilities under the proposed regulations, taking on a more active role in ongoing data management and regulatory coordination. Their duties will include:

Uploading and updating UDI data in the national database
Coordinating with provincial regulators and healthcare authorities on on code anomalies, recalls, and traceability incidents

Foreign manufacturers should work closely with qualified domestic agents who possess the technical capacity to manage UDI data efficiently and ensure compliance with NMPA requirements.

Final Thoughts

China’s planned expansion of the UDI system represents a continued effort to enhance traceability and data consistency across the medical device sector. As implementation progresses, early preparation will help manufacturers ensure compliance before the 2027 deadline and maintain stable access to the Chinese market.

With experience supporting over 100 overseas manufacturers in aligning documentation, data, and systems for UDI compliance, Cisema is ready to help you navigate these regulatory changes. Contact Cisema today for expert guidance and assistance with the consultation.