The Unique Device Identification (“UDI”) for the first batch of 69 varieties of Class III medical devices in nine categories was launched on January 1, 2021 and the UDI for the second batch of other Class III medical devices (including in vitro diagnostic reagents) was launched on June 1, 2022. In order to further implement the Regulation on the Supervision and Administration of Medical Devices, the Notice of the General Office of the State Council on Issuing the Reform Plan for the Control of High-value Medical Consumables and the relevant major tasks of the General Office of the State Council for deepening the medical and health care system reform, it is decided that some Class II medical devices will be implemented UDI as the third batch of varieties, and related matters are hereby announced as follows:

I. Range of varieties

According to the degree of risk and regulatory needs, some Class II medical devices, including single-use products in large clinical demand, products selected in the centralized volume-based procurement and medical cosmetology products, will be in the third batch of varieties for UDI implementation. The specific product list is shown in the attachment.

II. Scheduling

For medical devices listed in the third batch, registrants should conduct the following work in an orderly manner according to the time requirements:

(I) Assignment of unique device identifiers

From June 1, 2024, related medical devices produced should bear the unique device identifiers; products in the third batch for UDI implementation produced before this date may not bear the unique device identifiers.  The date of manufacture is subject to the labels of medical devices.

(II) Submission to the unique device identifier registration system

For registration applications from June 1, 2024, registration applicants should submit the product identifiers for their minimum sales units to the registration management system; for applications accepted or approved before June 1, 2024, registrants should, at the time of registration renewal or change in registration, submit the product identifiers for their minimum sales units to the registration management system.

Product identification is not a review item of registration, and its individual changes are not within the scope of registration change.

(III) Submission to the Unique Device Identifier Database

Before the marketing of medical devices produced from June 1, 2024, registrants should upload the product identifiers and relevant data for their minimum sales units or higher-level packaging to the Unique Device Identifier Database according to the requirements of the relevant standards or specifications and ensure that the data is true, accurate, complete, and traceable. For medical devices on which information has been maintained in the Healthcare Security Medical Consumables Classification and Code Database of the National Healthcare Security Administration, registrants should supplement and improve healthcare security medical consumables classification and code fields in the Unique Device Identifier Database, improve unique device identifier information in the Healthcare Security Medical Consumables Classification and Code Database, and confirm that the data is consistent with that in the Unique Device Identifier Database.

In the event of changes to the relevant data of product identifiers for minimum sales units of medical devices, registrants should make changes and update the data in the Unique Device Identifier Database before marketing the products. In the event of changes to the product identifiers for minimum sales units of medical devices, registrants should upload the relevant data to the Unique Device Identifier Database according to steps for new product identifiers.

III. Relevant requirements

Medical device registrants should effectively implement their principal responsibility as enterprises, establish and improve traceability systems based on the UDI, and do a good job in product recall, tracking, tracing, etc. If product management categories change due to dynamic adjustments to the Classified Catalogues of Medical Devices, medical device registrants should implement the UDI according to the requirements of management categories after adjustment.

Medical device business enterprises should actively use the UDI in their business activities and assign unique device identifiers to incoming and outgoing products to realize traceability of products in circulation.

Medical institutions should actively use the UDI in clinical trials, charge payment, settlement and reimbursement, etc. and record the unique device identifiers of products for the whole process, so as to realize traceability of products in clinical practice.

Institutions that assign unique device identifiers should develop their own UDI standards and guidelines, guide medical device registrants to conduct unique device identifier creation and assignment, and verify the readability of unique device identifiers prepared according to their standards in the circulation and use links.

Provincial medical products administrations should strengthen training and guidance for the UDI work, promote demand and transform the product registration system in conjunction with the implementation work, organize local medical device registrants to conduct product identifier assignment and data uploading and maintenance as required, and strengthen coordination with local health and healthcare security authorities, to promote the integration of medical treatment, medical insurance and medicines supply.

Provincial health authorities should guide local medical institutions to actively use the UDI and strengthen the standardized management of medical devices in clinical applications.

Provincial healthcare security administrations should strengthen the associations between healthcare security medical consumables classification and codes and unique device identifiers and promote the transparency and intelligence of catalogue access, payment management, and volume-based tenders.

The announcement is hereby given.

Attachment: List of Third Batch of Medical Devices for Unique Device Identification Implementation

National Medical Products Administration, National Health Commission and National Healthcare Security Administration

February 10, 2023