Announcement of the National Medical Insurance Administration of the People's Republic of China on the Implementation of the Third Batch of Unique Identification of Medical Devices (No. 22 of 2023)

On January 1, 2021, the first batch of 69 third class medical devices in 9 major categories will be implemented with unique identification for medical devices. On June 1, 2022, the second batch of other Class III medical devices (including in vitro diagnostic reagents) will implement unique identification for medical devices. In order to further implement the "Regulations on the Supervision and Administration of Medical Devices", "Notice of the General Office of the State Council on Issuing the Reform Plan for the Treatment of High Value Medical Consumables", and the key tasks related to the deepening of the medical and health system reform by the State Council, it is decided to use some Class II medical devices as the third batch of varieties to implement the unique identification of medical devices. The relevant matters are hereby announced as follows:

1、 Variety range

According to the degree of risk and regulatory needs, some disposable products with high clinical demand, selected products in centralized mass procurement, and medical beauty related products in the second category of medical devices will be identified as the only identification implementation varieties for the third batch of medical devices. The specific product catalog is shown in the attachment

2、 Schedule

For medical devices listed in the third batch of implementation product catalogs, the registrant shall carry out the following work in an orderly manner according to the time limit requirements:

（1） Unique identifier assignment

Medical devices produced from June 1, 2024 should have a unique medical device identification; The third batch of products that have already been produced and implemented with unique identification may not have unique identification. The production date is based on the medical device label

（2） Unique identification registration system submission

For applications for registration starting from June 1, 2024, the registration applicant shall submit the product identification of the minimum sales unit of their product in the registration management system; For products that have been accepted or approved for registration before June 1, 2024, the registrant shall submit the product identification of the minimum sales unit in the registration management system when continuing or changing the registration of the product

Product identification is not a registration review matter, and individual changes to product identification do not fall within the scope of registration changes

（3） Unique identification database submission

Before the medical devices produced on June 1, 2024 are put on the market for sale, the registrant shall upload the product identification and related data of the minimum sales unit and higher level packaging in accordance with relevant standards or regulatory requirements to the unique identification database of the medical devices, ensuring that the data is true, accurate, complete, and traceable. For medical devices that have already maintained information in the medical insurance consumables classification and code database of the National Medical Insurance Bureau, it is necessary to supplement and improve the medical insurance consumables classification and code fields in the unique identification database. At the same time, improve the information related to the unique identification of medical devices in the medical insurance consumables classification and code database maintenance, and confirm the consistency with the data in the medical device unique identification database

When there is a change in the data related to the product identification of the minimum sales unit of medical devices, the registrant should make changes in the unique identification database of medical devices before the product is launched for sale to achieve data updates. When the product identification of the minimum sales unit of medical devices changes, data should be uploaded to the unique identification database of medical devices according to the newly added product identification

3、 Relevant requirements

Medical device registrants should effectively implement their main responsibilities, encourage the establishment of a sound traceability system based on unique identification, and do a good job in product recall, tracking, and other related work. For cases where the product management category changes due to dynamic adjustments in the Medical Device Classification Catalogue, the medical device registrant shall implement unique identification in accordance with the requirements of the adjusted management category

Medical device operating enterprises should actively apply unique identification in their business activities, do a good job of entering and leaving the warehouse with codes, and achieve traceability of products in the circulation process

Medical institutions should actively apply unique identifiers in clinical practice, such as clinical use, payment fees, settlement and reimbursement, and keep records of the entire process with codes to achieve product traceability in clinical processes

The issuing institution shall establish standards and guidelines for the preparation of unique identifiers for its own institution, guide medical device registrants in the creation and assignment of unique identifiers, and verify the readability of unique identifiers prepared according to its standards during circulation and use

The provincial-level drug supervision and management department should strengthen training and guidance on the unique identification work, promote the transformation of the product registration system based on the implementation needs, organize medical device registrants within the jurisdiction to carry out product coding, data uploading and maintenance work as required, strengthen collaboration with the health and medical insurance departments within the jurisdiction, and promote the linkage of the three medical systems

Provincial health departments should guide medical institutions within their jurisdiction to actively apply unique identifiers and strengthen the standardized management of medical devices in clinical applications

Provincial medical insurance departments should strengthen the association between the classification and code of medical consumables for medical insurance and the unique identification of medical devices, and promote transparency and intelligence in directory access, payment management, and volume bidding

Hereby announced

Attachment: Product Catalogue for the Third Batch of Medical Devices with Unique Identification

State Food and Drug Administration, National Health Commission, National Medical Insurance Bureau