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On February 17, the State Food and Drug Administration issued the Announcement of the State Food and Drug Administration, National Health Commission and National Healthcare Security Administration on the Implementation of Unique Identification of the Third Batch of Medical Devices (No. 22, 2023) (hereinafter referred to as the "Announcement"). The original text is as follows.

On January 1, 2021, the first batch of 69 Class-III medical devices in 9 categories was uniquely identified as medical devices. On June 1, 2022, the second batch of other Class-III medical devices (including in vitro diagnostic reagents) were uniquely identified as 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 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 uniquely identify some Class II medical devices as the third batch of medical devices. The relevant matters are hereby announced as follows:

I. Variety scope

According to the risk degree and regulatory needs, some disposable products with high clinical demand, selected products with centralized procurement, medical beauty related products and other Class-II medical devices are uniquely identified as the third batch of medical devices, and the specific product catalog is attached.

II. 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 identification encoding

Medical devices produced from June 1, 2024 shall have 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 from June 1, 2024, the registration applicants shall submit the product identification of the minimum sales unit of their products 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.

The product identification does not belong to the scope of registration review, and the individual change of the product identification belongs to 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 relevant data of the minimum sales unit and higher-level packaging to the unique identification database of the medical devices in accordance with relevant standards or regulatory requirements, so as to ensure that the data is true, accurate, complete and traceable. For medical devices with information maintained in the medical insurance consumables classification and code database of the National Healthcare Security Administration, it is necessary to supplement and improve the medical insurance consumables classification and code fields in the unique identification database, improve the information related to the unique identification of medical devices during maintenance of the medical insurance consumables classification and code database, and confirm the consistency with the data in the unique identification database of medical devices.

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

III. Relevant requirements

Medical device registrants shall 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 relevant work. For the change of product management category due to the dynamic adjustment of 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 shall actively apply unique identification in their business activities, do a good job in stock-in/out with codes, and achieve traceability of products in the circulation process.

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

The code assignment agency shall establish standards and guidelines for the preparation of its unique identification, guide medical device registrants in the creation and coding of unique identification, and verify the readability of unique identification prepared according to its standards during circulation and use.

Provincial drug supervision and management department shall strengthen training and guidance on the unique identification, 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 as required, strengthen collaboration with the health and medical insurance departments within the jurisdiction, and promote the medical, medical insurance and pharmaceutical linkage.

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

Provincial medical insurance departments shall strengthen the associated use of the medical insurance consumables classification and code with the unique identification of medical devices, and promote the transparency and intelligence of catalog access, payment management and volume bidding.

It is hereby announced.

Attached:

Catalogue of products with unique identification for the third batch of medical devices

According to the Classification Catalogue of Medical Devices, the following varieties (103) are listed:

I. Active surgical instruments

II. Passive surgical instruments

III. Neurological and cardiovascular surgical instruments

IV. Orthopaedic surgical instruments

V. Medical imaging instruments

VI. Medical examination and monitoring instruments

VII. Respiratory, anesthesia and first-aid instruments

VIII. Physical therapy instruments

IX. Blood transfusion, dialysis and extracorporeal circulation instruments

X. Active implantable devices

XI. Infusion, nursing and protective instruments

XII. Ophthalmological instrument

XIII. Obstetrics and gynecology, assisted reproduction and contraceptive devices

XIX. Medical rehabilitation instruments

XV. Clinical testing instruments

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