Machinery / Industrial Parts & Tools

Recently, the State Food and Drug Administration issued a notice that all Class III medical devices (including in vitro diagnostic reagents) will be included in the scope of the implementation of unique identification. Support and encourage other medical device varieties to implement unique identification.

Regarding the implementation of the second batch of medical devices

Announcement that uniquely identifies the job

(Draft for comments)

Starting from January 1, 2021, the first batch of 69 medical device varieties in 9 categories will implement unique identification. 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 Governance of High-Value Medical Consumables" and the key tasks of the State Council in deepening the reform of the medical and health system, the second batch of unique identification of medical devices will now be implemented Relevant matters are announced as follows:

Implementation variety

On the basis of the 9 categories and 69 varieties stipulated in the "Announcement of the National Medical Products Administration, National Health Commission, and National Medical Insurance Bureau on Deepening the Pilot Program and Doing the First Batch of Implementation of the Unique Identification of Medical Devices" (No. 106, 2020), The remaining third-class medical devices (including in vitro diagnostic reagents) will be included in the second batch of implementation of unique identification scope. Support and encourage other medical device varieties to implement unique identification.

Implementation time

The medical device registrants included in the second batch of unique identification shall carry out their work in accordance with the following requirements:

Unique identification code

Starting from March 1, 2022, medical devices produced should have a unique identification of medical devices; the second batch of products that have been produced before that implement unique identification may not have a unique identification. The production date is subject to the medical device label.

Unique identification registration system submission

From March 1, 2022, when applying for the first registration, renewal or registration change, the registration applicant/registrant shall submit the product identification of its smallest sales unit in the registration management system.

Product identification is not a matter of registration review, and individual changes in product identification do not belong to the scope of registration changes.

Uniquely identify database submission

For medical devices produced from March 1, 2022, before they are marketed for sale, the registrant shall upload the product identification and related data of the smallest sales unit and higher-level packaging to the medical device unique identification database in accordance with relevant standards or specifications. Ensure that the data is true, complete and traceable. For medical devices that have maintained information in the medical insurance medical consumables classification and code database of the National Medical Insurance Administration, it is necessary to supplement and improve the medical insurance medical consumables classification and code fields in the unique identification database, and improve the medical devices in the medical insurance medical consumables classification and code database maintenance. Unique identification (UDI-DI) information, and confirm the consistency with UDI database data.

When the data related to the product identification of the smallest sales unit of a medical device changes, the registrant shall make changes in the medical device unique identification database before the product goes on sale to achieve data update. When the product identification of the smallest sales unit of a medical device changes, the data shall be uploaded in the medical device unique identification database according to the newly-added product identification.

Relevant requirements

Medical device registrants should earnestly implement the main responsibility of the enterprise, encourage the establishment of a sound traceability system based on unique identification, and do a good job in product recall, traceability and other related work. In the case of changes in the product management category due to the dynamic adjustment of the "Medical Device Classification Catalog", the medical device registrant shall implement a unique identification in accordance with the requirements of the adjusted management category.

Medical device operating companies should actively apply unique identifiers in their business activities, do a good job of entering and leaving the warehouse with codes, so as to realize the traceability of products in the circulation link.

Medical institutions shall actively apply unique identifiers in clinical practice such as clinical use, payment of fees, settlement and reimbursement, and make records with codes throughout the entire process to realize the traceability of products in the clinical process.

Provincial drug supervision and management departments should strengthen the training and guidance of unique identification work, organize medical device registrants in their jurisdictions to carry out product coding, data upload and maintenance work as required, and strengthen coordination with the health and medical insurance departments in their jurisdictions to promote the linkage of the three medicines.

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

Provincial medical insurance departments should strengthen the associated use of the classification and code of medical consumables for medical insurance and the unique identification of medical devices, and promote the transparency and intelligence of payment and settlement, and bidding with quantity.