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 relevant key tasks of the State Council on deepening the reform of the medical and health system, and, on the basis of implementing Unique Device Identification (UDI) for all Class III medical devices (including in vitro diagnostic reagents) and 103 Class II medical device products, the relevant work on implementing UDI for subsequent medical device products is hereby announced as follows:

I. Scope of products

Medical device products for which the implementation of UDI is specified in the Announcement of the National Medical Products Administration, the National Health Commission and the National Healthcare Security Administration on Further Advancing the Pilot Program and Effectively Implementing UDI for the First Batch of Medical Devices (No. 106, 2020), the Announcement of the National Medical Products Administration, the National Health Commission and the National Healthcare Security Administration on Effectively Implementing UDI for the Second Batch of Medical Devices (No. 114, 2021), and the Announcement of the National Medical Products Administration, the National Health Commission and the National Healthcare Security Administration on Effectively Implementing UDI for the Third Batch of Medical Devices (No. 22, 2023) shall be excluded.

II. Schedule arrangements

Medical device registrants or filers shall carry out the following work in an orderly manner as required.

(1) UDI assignment

All Class II medical devices (including in vitro diagnostic reagents) and all Class I in vitro diagnostic reagents manufactured on or after June 1, 2027 shall be assigned UDI. The above products manufactured before June 1, 2027 may be exempted from UDI assignment.

All Class I medical devices manufactured on or after June 1, 2029 shall be assigned UDI. The above products manufactured before June 1, 2029 may be exempted from UDI assignment.

(2) Submission of device identifier to the registration/filing administration system

For applications for registration/filing submitted on or after the corresponding implementation date, medical device registration applicants or filers shall submit the device identifier of the smallest sales unit of their products in the registration/filing administration system. For products for which registration has been accepted or approved before the corresponding implementation date, registrants shall submit the device identifier of the smallest sales unit of their products in the registration system at the time of product registration renewal or registration change. For products for which filing has been completed before the corresponding implementation date, filers shall submit the device identifier of the smallest sales unit of their products in the filing system at the time of product filing change.

The device identifier shall not be subject to registration/filing review, and independent changes to the device identifier shall not fall within the scope of registration/filing changes.

(3) Submission to the UDI database

For all Class II medical devices (including in vitro diagnostic reagents) and all Class I in vitro diagnostic reagents manufactured on or after June 1, 2027, and all Class I medical devices manufactured on or after June 1, 2029, medical device registrants or filers shall upload the device identifier and relevant data of the smallest sales unit and higher-level packaging to the UDI database in accordance with relevant standards or specifications prior to product marketing, to ensure the data are authentic, accurate, complete, and traceable. For medical devices whose information has been maintained in the healthcare security classification and code databases of the National Healthcare Security Administration, such as the Healthcare Security Medical Consumables Database and the Healthcare Security In Vitro Diagnostic Reagents Database, the corresponding fields for healthcare security classification and codes (including those for medical consumables, in vitro diagnostic reagents, etc.) shall be supplemented in the UDI database. Meanwhile, UDI-related information shall be supplemented in the maintenance of the aforementioned healthcare security classification and code databases, and consistency with the data in the UDI database shall be verified.

Where relevant data of the device identifier of the smallest sales unit of a medical device changes, the medical device registrant or filer shall make modifications to the UDI database to update the data prior to product marketing. Where the device identifier of the smallest sales unit of a medical device changes, data shall be uploaded to the UDI database as a newly added device identifier.

III. Relevant requirements

(1) Medical device registrants or filers shall earnestly fulfill their primary responsibilities. They are encouraged to establish and improve a traceability system based on UDI, and properly carry out product recall, tracking and traceability, adverse event monitoring, and other relevant work. Where the regulatory class of a product changes due to adjustment of the Classification Catalogue for Medical Devices, medical device registrants or filers shall implement UDI in accordance with the requirements of the adjusted regulatory class. For medical devices eligible for UDI exemption in accordance with the Announcement of the National Medical Products Administration on the Implementation of Unique Device Identification for Medical Devices in Specific Circumstances (No. 15, 2026), medical device registrants or filers may be exempted from UDI implementation in accordance with the requirements of the Rules for Unique Device Identification System.

(2) Medical device distributors shall actively apply UDI in business activities, and properly conduct code-based warehousing and delivery. Enterprises shall upload relevant information to the National Healthcare Security Information Platform in accordance with the relevant provisions of healthcare security authorities to realize traceability of products in the circulation sector.

(3) Medical institutions shall actively apply UDI in clinical practices such as clinical use, adverse event reporting, payment and charging, and settlement and reimbursement, keep full-process code-based records, and realize traceability of products in the clinical sector.

(4) Issuing agencies shall formulate UDI coding standards and guidelines for their own agencies, guide medical device registrants or filers in UDI creation and assignment, and verify the readability of UDI coded in accordance with their standards in the circulation and use sectors.

(5) Provincial drug regulatory authorities shall strengthen training and guidance on UDI implementation, upgrade the medical device registration/filing system to meet the needs of implementation work, organize medical device registrants or filers within their jurisdictions to carry out product coding, data upload and maintenance as required, strengthen coordination with health and healthcare security authorities within their jurisdictions, and promote tripartite coordination among healthcare, medical insurance, and drugs.

(6) Provincial health authorities shall guide medical institutions within their jurisdictions to actively apply UDI and strengthen standardized management of medical devices in clinical use.

(7) Provincial healthcare security authorities shall strengthen the associated application of healthcare security classification and codes for medical consumables, in vitro diagnostic reagents, and other items with UDI, and promote transparency and intelligence of catalog access, payment management, volume-based procurement, and other work.

It is hereby announced.

National Medical Products Administration  National Health Commission  National Healthcare Security Administration

March 4, 2026