On September 17, the National Medical Products Administration issued a draft notice on the first batch of unique labeling of medical devices, soliciting opinions on the first batch of unique labeling of more than 60 types of medical devices, including implantable heart pacemakers and hip implants.These medical devices are the third high-risk medical devices, such as some active implants and passive implants.

Draft clearly, listed in the first implementation of product catalog of medical apparatus and instruments, since August 1, 2020, should have the unique identification of medical equipment, before sale, the registrant shall be in accordance with the requirements of relevant standards or specifications will be packed minimum sales unit, a higher level of product identification and related data uploaded to the medical equipment uniquely identifies the database.From August 1, 2020, for the first registration, the applicant shall submit the product logo of its minimum sales unit in the registration management system.If the registration has been accepted or approved before, the product identification of its minimum sales unit shall be submitted in the registration management system when the product registration is continued or changed.When the data related to the product identification of the minimum sales unit changes, the registrant shall submit a change application to the unique identification database of medical devices before the product is sold on the market, and update the data after approval.

According to the draft, the first batch of registrants who carry out the unique identification work should carry out coding, data uploading and other work strictly in accordance with the requirements, and be responsible for the authenticity, accuracy and integrity of the data.Registrants are encouraged to establish an information traceability system for medical devices by using the unique identification, so as to realize full traceability of product production, circulation and use.Enterprises and users are encouraged to actively apply the unique identification of medical devices in their relevant management activities, explore the establishment of a traceability chain with the upstream and downstream, and promote the connection and application.