On July 19, the Comprehensive Department of the National Medical Products Administration publicly sought comments on the “Notice on Effectively Implementing the Second Batch of Unique Device Identification (Draft for Comments).” According to reports, the implementation of the second batch of UDI is expected to officially take effect after August 16, 2021.

Building upon the nine categories and 69 product types specified in the “Announcement of the National Medical Products Administration, the National Health Commission, and the National Healthcare Security Administration on Further Advancing Pilot Programs and Effectively Implementing the First Batch of Unique Device Identification for Medical Devices” (No. 106, 2020), Include the remaining Class III medical devices (including in vitro diagnostic reagents) in the second batch of products subject to unique identification. . Support and encourage the implementation of unique device identification for other medical device categories.

Medical device registration holders included in the second batch of products subject to unique identification shall carry out their work in accordance with the following requirements:

(1) Unique Identifier Coding

Effective March 1, 2022, all medical devices manufactured shall bear a unique device identifier. The second batch of products that have already been manufactured and are subject to the unique identification requirement may not bear a unique identifier. . The date of manufacture shall be determined by the medical device label.

(2) Submission to the Unique Identification Registration System

Effective March 1, 2022, when applying for initial registration, renewal of registration, or a change to registration, the applicant/registrant shall, within the registration management system, Submit the product labeling for its smallest sales unit.

Product labeling is not subject to registration review, and standalone changes to product labeling do not fall within the scope of registration amendments.

(3) Submission to the Unique Identification Database

Medical devices manufactured on or after March 1, 2022, shall, prior to their market release, have the product identifiers and associated data for the smallest saleable unit and higher-level packaging uploaded to the Medical Device Unique Identification Database in accordance with relevant standards or regulatory requirements, ensuring that the data are accurate, complete, and traceable. For medical devices whose information has already been maintained in the National Healthcare Security Administration’s Medical Consumables Classification and Coding Database, It is necessary to supplement and refine the classification and coding fields for medical consumables in the unique identification database, while also enriching the medical device unique identification (UDI‑DI) information in the maintenance of the medical consumable classification and coding database, and ensuring data consistency with the UDI database.

When the product identification data of the smallest saleable unit of a medical device changes, the registrant shall make the corresponding updates in the Unique Device Identification (UDI) database prior to placing the device on the market, thereby ensuring that the data is current. If the product identification of the smallest saleable unit changes, the registrant shall upload the new product identification data to the UDI database as if it were a newly added product.

Medical Device Registration Holder It is essential to effectively enforce the principal responsibility of enterprises, encourage the establishment and improvement of traceability systems based on unique device identifiers, and ensure proper implementation of product recalls, tracking, and traceability measures. In cases where the management classification of a medical device changes due to dynamic adjustments to the Medical Device Classification Catalogue, the medical device registrant shall implement the unique device identifier in accordance with the requirements applicable to the revised classification.

Medical device operating enterprise In business operations, the unique identifier should be actively implemented to ensure proper coding‑based inbound and outbound logistics, thereby enabling product traceability throughout the distribution chain.

Medical institution In clinical practice—covering use, payment, and reimbursement—it is essential to actively implement the Unique Device Identifier, maintain end-to-end coded records, and ensure product traceability throughout all clinical stages.

Provincial drug regulatory authorities shall strengthen training and guidance on the unique identification system, organize medical device registration holders within their jurisdictions to carry out product coding, data uploading, and maintenance in accordance with applicable requirements, and enhance coordination with local health and medical insurance authorities to promote integrated collaboration among the healthcare, pharmaceutical, and medical insurance sectors.

Provincial health authorities shall guide medical institutions within their jurisdictions to actively implement the unique identification system and strengthen standardized management of medical devices in clinical settings.

Provincial medical insurance authorities should strengthen the linkage between the classification and coding of medical consumables under the medical insurance system and the Unique Device Identification (UDI) for medical devices, thereby promoting transparency and digitalization in payment settlement, volume‑based procurement, and other related processes.