Started from January 1, 2021, 69 high-risk class III devices were included in the UDI application of First Batch of Devices. After that, UDI has been implemented in all Class III devices and IVDs,effective from June 1, 2022.
Overseas manufacturers need to register their devices in the China national UDI database. In essence, after you get your NMPA registration approval, both UDI and NHSA are needed in order to sell into public hospitals.
China NMPA recently made an announcement on November 30, 2022mandating many Class II devices to meet UDI submission requirements. The final list was released by NMPA on February 10, 2023.
The document "Implementation of the Third Batch of Medical Devices UDI", requires manufacturers to submit UDI application for the following Class II devices:
1. Disposable products with high volume clinical usage
2. Selected products for volume based purchasing
3. Medical aesthetic products
The notice says that for class II devices:
1. Class II and Class III devices manufactured after June 1, 2024, shall have unique identifiers.
2. Devices manufactured before June 1, 2024, are not required to have unique identifiers.
3. Starting June 1, 2024, for initial registrations, renewal and modification registrations, the applicants shall submit the identifiers of the smallest sales unit to the registration management system.
Below are the Third Batch Devices:
1. Ultrasound surgery equipment accessories
2. Medical laser
3. High-frequency surgical equipment
4. Argon protection aerocoagulation equipment
5. Electrodes and catheters for high frequency/radio frequency
6. Perfusion pumps for RF ablation equipment
7. Active devices for endoscopic surgery
8. Electric stapler
9. Stapler (with nails)
10. Stapler (without spikes)
11. Vascular suture device
12. Non-absorbable sutures
13. Lithotomy instruments for endoscopy
14. Bladder catheters for endoscopes
15. Balloon compression device for balloon dilation catheters
16. Orthopedic endoscope with a knife
17. Orthopedic power surgery equipment
18. Urinary X-ray machine
19. Laser treatment equipment
20. Cardiac rhythm management program-controlled devices
21. Neuromodulation program-controlled devices
22. Pen injectors
23. Pocket tension ring implant device
24. Gynecological prosthetic devices
25. Blood cell analysis instruments
26. … …
Love to hear your experience if you have gone through class III devices UDI requirements, any challenges or questions you may have for the upcoming class II devices UDI.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------