How Is the Unique Identification Going? Start in the Second Half of the Year
2022-07-15
According to reports, the landing speed of medical device “ID cards” in the second half of the year will be further accelerated, and by the end of 2022, more varieties will be covered.
The report points out that at present, the logo may be widely used in the third-party logistics of medical devices. At present, the electronization of pharmaceutical management and logistics industry has basically been upgraded. The next step is to start strict management in the transportation and storage links. The informatization and digitalization of the third-party logistics industry will definitely promote the implementation of UDI, the unique identification of medical devices, and realize the traceability of medical devices.
The NMPA, the National Health Commission and the National Medical Insurance Bureau jointly issued the Announcement on Doing a Good Job in the Second Batch of Implementing the Unique Identification of Medical Devices， which clearly mentions that from June 1, 2022, on the basis of the 69 varieties of the nine categories stipulated in the “First Batch of Implementing the Unique Labeling of Medical Devices”, the remaining Class III medical devices (including in vitro diagnostic reagents) will be included in the second batch of implementing the unique labeling.
This requires that the medical devices produced should have the unique identification of medical devices. Before going on sale, the registrant should upload the product identification and related data of the smallest sales unit, higher-level packaging to the unique identification database of medical devices in accordance with relevant standards or specifications, to ensure that the data is true, accurate, complete and traceable.
This means that medical institutions will actively apply unique identifiers in clinical practice such as clinical use, payment of fees, settlement and reimbursement, etc.
At the regulatory level, the new version of the Measures for the Supervision and Administration of Medical Device Production is implemented, which clearly stipulates the unique identification of medical devices. Medical device registrants, filing parties, and entrusted manufacturers shall carry out coding, data uploading, maintenance and updating in accordance with the relevant requirements of the state for the implementation of unique identification of medical devices.
According to Article 79, those who fail to organize code assignment, data upload, maintenance and update in accordance with the relevant requirements of the state for the implementation of the unique identification of medical devices shall be ordered by the drug regulatory department to make corrections within a time limit according to its duties; Those who refuse to make corrections shall be fined not less than 10000 yuan but not more than 50000 yuan; If the circumstances are serious, a fine of not less than 50000 yuan but not more than 100000 yuan shall be imposed.
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