NMPA issued the Announcement on the implementation of the third batch of Medical Devices UDI (Draft for Comments) on November 30, 2022. (Hereinafter referred to as the Draft for Comments).
The draft for comments points out that, in accordance with the risk degree and regulatory needs, some disposable products with great clinical demand, varieties listed in the scope of medical insurance collection, medical cosmetology related products and other Class II medical devices will be identified as the unique identification and implementation of the third batch of medical devices.
The implementation of the third batch unique identification of medical devices catalog includes 141 medical devices, such as ultrasound surgical equipment accessories, medical laser fiber, high-frequency surgical equipment, electric anastomoses, vascular suture devices, optical endoscopes, electronic endoscopes, peritoneal dialysis equipment, pacing system analysis equipment, biopsy needles, protective clothing, hearing aids, blood cell analysis instruments, etc.
For the medical devices listed in the third batch of implementation product catalog, the registration applicant shall pay attention to the following points:
According to the draft, medical devices manufactured from June 1, 2024, should have a UDI; The third batch of products previously produced with unique marking may not have unique marking. The production date is subject to the label of the medical device.
For those applying for registration from June 1, 2024, the applicant shall submit the product identification of its smallest sales unit in the registration management system; If the registration has been accepted or approved before June 1, 2024, the registration applicant shall submit the product identification of its minimum sales unit in the registration management system when the product registration is renewed or changed.
For the medical devices manufactured from June 1, 2024, before they are put on the market, the registration applicant shall upload the product identification of the minimum sales unit and higher level packaging and relevant data to the unique identification database of medical devices in accordance with relevant standards or specifications, so as to ensure that the data are true, accurate, complete and traceable.
For medical devices whose information has been maintained in the medical Insurance Medical Consumables Classification and code database of the National Healthcare Security Administration, the medical insurance medical consumables classification and code fields should be supplemented and improved in the unique identification database of medical insurance medical consumables. Meanwhile, relevant information about the UDI of medical devices should be improved in the maintenance of the medical insurance medical consumables classification and code database, and the consistency with the data in the medical device UDI database should be confirmed.
The more detail information of the third batch of medical devices UDI startup in China, please contact firstname.lastname@example.org.