To further implement the Regulations for the Supervision and Administration of Medical Devices, the Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Regulation of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry, and the key tasks of the State Council concerning the deepening of the reform of the medical and health system, and to better guide the implementation of the Unique Device Identification (UDI) system for medical devices, the relevant matters concerning the implementation of UDI for medical devices in specific circumstances are hereby announced as follows:

I. Circumstances for exemption from UDI implementation

Exemption from UDI implementation refers to the exemption from the creation, coding, and database submission of the UDI in accordance with the requirements of the Rules for Unique Device Identification System (hereinafter referred to as the Rules).

(1) Except for implanted medical devices classified under classification codes 12-XX or 13-XX, where the smallest sales unit package of a medical device contains multiple single-use medical devices with the same specification, model, and production batch number, and the smallest sales unit package has already been assigned a UDI, the individual medical devices within the smallest sales unit package may be exempted from UDI implementation. Examples include condoms, blood collection tubes, and medical masks contained in the smallest sales unit package.

(2) Customized medical devices, as defined in the Provisions on the Supervision and Administration of Customized Medical Devices (Trial), may be exempted from UDI implementation.

(3) If a medical device combination package is assigned a UDI as a whole, and the single-use medical devices contained therein are only used under the condition of the medical device combination package, the single-use medical devices in the medical device combination package may not be assigned a UDI. If a medical device contained in a medical device combination package is already exempted from the implementation of UDI, it shall not be assigned a UDI when included in the medical device combination package.

(4) Transportation packaging of medical devices may be exempted from the implementation of UDI.

(5) Medical devices intended only for export and not for sale or use in China may be exempted from implementation of UDI, but shall comply with the requirements of the importing country (region).

(6) Drug-led drug-device combination products may be exempted from the implementation of UDI on the premise that the drugs are traceable.

(7) Where a drug and a single-use medical device are packaged together as one smallest sales unit, and the medical device is described in the drug package insert, and the smallest sales unit bears a drug traceability code, the single-use medical device in the package may not be assigned a UDI.

II. Implementation requirements for other specific circumstances

(1) For reusable medical devices that require reprocessing before each use, UDI shall be applied directly to the device body to ensure the product can be uniquely identified before each use. If directly marking UDI on the device body may affect the safety and effectiveness of the product or is technically infeasible, UDI may not be directly marked on the device body; however, the medical device registrant or filer shall mark UDI on the smallest sales unit package of the product and provide other effective schemes for identification and traceability for reuse.

(2) Reusable surgical devices regulated as Class I medical devices may not be required to bear the Production Identifier (UDI-PI) under the UDI system, but shall bear the Device Identifier (UDI-DI) under the UDI system.

(3) For standalone software provided through non-physical media, a physical UDI data carrier may not be required, but UDI shall be provided in an easily readable plain text format on a user-visible interface of the software; for standalone software without a user interface, UDI shall be transmitted via Application Programming Interface (API).

The electronic display content of UDI for standalone software only needs to provide the human-readable part (including data separators).

III. Other Matters

(1) For medical device products eligible for exemption from implementation of UDI, medical device registrants or filers may decide whether to conduct creation and assignment of UDI in accordance with the requirements of the Rules and upload relevant data to the UDI database based on their actual needs. Specifically, products for which UDI has been implemented in accordance with the requirements of the Rules may independently choose to continue or discontinue implementation, and the product information already published in the UDI database shall remain published.

(2) The NMPA may adjust the requirements for implementation of UDI according to the needs of medical device regulation.

It is hereby announced.

National Medical Products Administration

January 23, 2026