Started from January 1, 2021, 69 high-risk class III devices were included in the Unique Device Identification (UDI) application of First Group of Devices. After that, UDI has been implemented in all Class III devices and IVDs, effective from June 1, 2022.
We have been helping our overseas clients to register their devices in the China national UDI database. In the addition to the UDI requirements, China also requires NHSA code in order to sell into public hospitals. In essence after you get your NMPA registration approval, both UDI and NHSA are needed in order to sell into public hospitals.
To keep up with international standards and help device manufacturers prepare for regulatory compliance further, China NMPA recently made an announcement on November 30, 2022, and mandated many Class II devices shall meet UDI submission requirements. The Draft "Implementation of the Third Batch of Medical Devices UDI", required manufacturers to submit UDI application for the Class II devices below:
- Disposable products with large clinical demand
- Varieties included in the scope of medical insurance
- Medical aesthetic products
The Notice says that:
- Devices manufactured before June 1, 2024, are not required to have unique identifiers.
- Above Class II devices manufactured after June 1, 2024, shall have unique identifiers.
- Starting June 1, 2024, for initial registrations, modification and renewal registrations, the applicants shall submit the identifiers of the smallest sales unit to the registration management system.
The Third Batch Devices are listed below for your information:
- Ultrasound surgery device accessories
- Medical laser fiber
- High-frequency surgical device
- Argon protection aerocoagulation device
- Electrodes and catheters for high frequency/radio frequency
- Perfusion pumps for RF ablation device
- Active devices for endoscopic surgery
- Electric stapler
- Surgical power system
- Endoscopic knife
- Endoscopic sampling forceps
- Airbag dilator for endoscope
- Endoscope guides
- Stapler (with nails)
- Stapler (without spikes)
- Vascular suture device
- Non-absorbable sutures
- Lithotomy instruments for endoscopy
- Bladder catheters for endoscopes
- Dilator
- Balloon compression device for balloon dilation catheters
- Orthopedic endoscope with a knife
- Orthopedic power surgery device
- Urinary X-ray machine
- Laser treatment device
- Cardiac rhythm management program-controlled devices
- Neuromodulation program-controlled devices
- Syringe pump
- Pen injectors
- Transnasoenteral nutrition catheter
- Pocket tension ring implantation device
- Hysterosalpingography, fallopian tubes
- Gynecological prosthetic devices
- Assisted reproductive catheter
- Blood cell analysis instruments
If your devices have any challenges in regulatory compliance for UDI submission in China, feel free to comment below for a chat.
------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------