On January 1, 2021, the first batch of 69 third-class medical devices in 9 categories implemented the unique identification of medical devices. On June 1, 2022, the second batch of other Class III medical devices (including in vitro diagnostic reagents) will implement the unique identification of medical devices. In order to further implement the “Regulations 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 Management of High-Value Medical Consumables, and the key tasks of the State Council in deepening the reform of the medical and health system, it has been decided to implement the unique identification of some Class II medical devices as the third batch of varieties. The relevant matters are hereby announced as follows:
1. Variety range
According to the degree of risk and regulatory needs, some second-class medical devices such as single-use products with large clinical demand, products selected for centralized mass procurement, and medical beauty-related products are determined to be the third batch of medical device unique identification implementation varieties. The specific product catalog is shown in the attachment.
2. Progress Arrangement
For medical devices included in the third batch of implemented product catalogs, registrants should carry out the following work in an orderly manner in accordance with the time limit requirements:
(1) Unique identification code assignment
Medical devices produced from June 1, 2024 should have unique identification of medical devices; the third batch of previously produced products that implement unique identification does not need to have unique identification. The production date is based on the medical device label.
(2) Submission of unique identification registration system
If applying for registration starting from June 1, 2024, the registration applicant shall submit the product identification of the minimum sales unit of its product in the registration management system; if the registration has been accepted or approved before June 1, 2024, the registrant shall submit the product identification of the minimum sales unit of its product in the registration management system when the product is renewed or changed.
Product identification is not a matter of registration review, and individual changes in product identification do not fall within the scope of registration changes.
(3) Submission of unique identification database
For medical devices produced from June 1, 2024, before they are put on the market for sale, registrants should upload the product identification and related data of the minimum sales unit and higher-level packaging to the medical device unique identification database in accordance with relevant standards or specifications to ensure that the data is authentic, accurate, complete, and traceable. For medical devices that have maintained information in the National Medical Insurance Bureau’s medical consumables classification and coding database, the medical device classification and code fields must be supplemented and improved in the unique identification database. At the same time, the medical device unique identification related information must be improved in the maintenance of the medical insurance medical consumables classification and coding database, and the consistency with the medical device unique identification database data must be confirmed.
When the data related to the product identification of the minimum sales unit of a medical device changes, the registrant should make changes in the medical device unique identification database to update the data before the product is put on the market. When the product identification of the minimum sales unit of a medical device changes, the data should be uploaded in the medical device unique identification database according to the new product identification.
3. Relevant requirements
Medical device registrants must effectively implement their main responsibilities, encourage the establishment of a sound traceability system based on unique identifiers, and do a good job in product recall, tracking and tracing and other related work. In the event that the product management category changes due to the dynamic adjustment of the “Medical Device Classification Catalog”, the medical device registrant shall implement unique identification in accordance with the requirements of the adjusted management category.
Medical device operating companies must actively apply unique identifiers in their business activities, carry out code entry and exit, and achieve traceability of products in the circulation process.
Medical institutions must actively apply unique identifiers in clinical practices such as clinical use, payment and reimbursement, and keep coded records throughout the process to achieve traceability of products in the clinical process.
The coding agency must formulate standards and guidelines for the preparation of unique identifiers for its own organization, guide medical device registrants to create and assign unique identifiers, and verify the readability of unique identifiers prepared in accordance with its standards during circulation and use.
Provincial drug regulatory authorities should strengthen training and guidance on unique identification, reform the product registration system based on implementation needs, organize medical device registrants within their jurisdictions to carry out product coding, data uploading and maintenance as required, strengthen collaboration with the health and medical insurance departments within their jurisdictions, and promote the linkage of the three medical devices.
Provincial health departments should guide medical institutions within their jurisdiction to actively use unique identifiers and strengthen the standardized management of medical devices in clinical applications.
Provincial medical insurance departments should strengthen the association of medical insurance medical consumable classifications and codes with unique identifiers of medical devices, and promote transparency and intelligence in catalog access, payment management, and volume-based bidding.
Announcement is hereby made.
Attachment: The third batch of product catalogs that implement unique identification of medical devices (scan the QR code to view)
State Food and Drug Administration National Health Commission National Medical Insurance Administration
February 10, 2023
Original text: Announcement of the State Food and Drug Administration, National Health Commission, and National Medical Insurance Administration on the implementation of the third batch of unique identification of medical devices