The "Notice on Matters Concerning the Implementation of the First Batch of Medical Device Unique Identification" has been officially released.

To implement the "Notice of the General Office of the State Council on Issuing the Reform Plan for the Governance of High-Value Medical Consumables" (Guo Ban Fa [2019] No. 37), the National Medical Products Administration (NMPA) issued the "Rules for the Unique Identification System of Medical Devices" and, together with the National Health Commission, jointly conducted pilot work on the unique identification system for medical devices.On October 14, the NMPA issued the "Notice on Doing a Good Job in Matters Related to the Implementation of the Unique Identification of Medical Devices in the First Batch" (hereinafter referred to as the "Notice"). The Notice clearly stipulates the scope of varieties, schedule, and work requirements for the first batch of medical device unique identification implementations. According to the Notice,
 

According to the risk level and regulatory needs, the Notice specifies some high-risk Class III medical devices, including active implantable devices and passive implantable devices, as the first batch of medical devices for unique identification implementation. Nine categories64 varieties were included in the first batch of product catalogs for implementing unique identification of medical devices.

The Notice requires that for medical devices included in the first batch implementation catalog, the registrant should follow the requirements of the Rules and, in a timely and orderly manner, complete the unique identification coding, submission to the unique identification registration system, and submission to the unique identification database. According to the Notice,From October 1, 2020, medical devices produced should have a unique identification; medical devices produced before October 1, 2020, may not have a unique identification. The production date is based on the medical device label.
 

The Notice requires,From October 1, 2020, when applying for initial registration, renewal registration, or registration changes, the applicant/registrant should submit the product identification of its smallest sales unit in the registration management system. Product identification is not a registration review item; a separate change in product identification does not constitute a registration change.
 

In addition, according to the Notice,From October 1, 2020, for medical devices produced, before they are put on the market, the registrant should upload the product identification of the smallest sales unit and higher-level packaging, and relevant data to the unique identification database for medical devices according to relevant standards or specifications; when the relevant data of the product identification of the smallest sales unit of the medical device changes, the registrant should make changes in the unique identification database for medical devices before the product is put on the market, to update the data. When the product identification of the smallest sales unit of a medical device changes, the data should be uploaded to the unique identification database for medical devices as a new product identification.
 

The Notice also requires that the registrants of the first batch of unique identification work strictly implement the requirements to carry out coding, data upload, and maintenance, and be responsible for the authenticity, accuracy, and integrity of the data; encourages registrants to use the unique identification of medical devices to establish an information traceability system for medical devices, to achieve full traceability of their product production, circulation, and use; encourages medical device manufacturing and operating enterprises and using units to actively use the unique identification of medical devices in their relevant management activities, to explore the establishment of a traceability chain with upstream and downstream companies, to promote coordinated application; and relevant departments actively carry out training and publicity.