China's National Medicines Agency (NMPA) has announced amendments to its catalog to classify medical devices.
Manufacturers need a lot of attention because the amendment affects the cost and time of medical device registration.
The 56 changes announced include adding new products, changing descriptions of some devices, and changing some device classifications. We inform you of the major revisions as follows.
< Up-Classifications >
| Item | Previous Classification | New Classification |
| Ultrasonic cutting hemostatic blade, ultrasonic soft tissue surgical blade, ultrasonic suction surgical blade |
Class II (as Ultrasonic surgery equipment accessories) |
Class III (separated to distinguish from other utrasonic surgery equipment accessories) |
| Ultrasonic bone tissue scalpel head, dental ultrasonic therapy instrument head | Class II (as Ultrasonic surgery equipment accessories) |
Class II (remains the same) |
| Additive manufacturing bone plate trial model, additive manufacturing orthopedic positioning rod, additive manufacturing orthopedic surgical guide | Class I | Class II |
| Rod, additive manufacturing orthopedic surgical guide | Class I | Class II |
| Additive manufactured joint prosthesis trial models | Class I | Class II |
| Additive manufacturing spinal surgery guides | Class I | Class II |
| Microwave tumor hyperthermia machines | Class II | Class III |
< Down-Classifications >
| Item | Previous Classification | New Classification |
| Separate control boxes like pring coil separation control box, separation control box | Class III | Class II |
| Guide cannulas | Class III | Class II |
| Guide wires | Class III | Class II |
| Products used for the reduction of fractures and/or the formation of a cavity in the cancellous bone of the vertebral body that can be filled with fillers to restore the height of the vertebral body, i.e. Vertebral dilation balloon catheters, bone expanders, vertebroplasty support systems, bone expanders, expandable bone shapers | Class III | Class II |
| Anti-scatter grids | Class II | Class I |
| X-Ray photography cassettes | Class II | Class I |
| Automated sampling systems for clinical labs | Class II | Class II |
< New Additions >
| Item | Classification |
| Left atrial appendage clipping system | Class III |
| Artificial corneas | Class III |
| Disposable absorbable staples | Class III |
| Breast rotary biopsy system, breast rotary cutting puncture needle, and accessories | Class III |
| Cerebral thrombus removal devices | Class II |
| Mechanical perfusion and transfer equipment for isolated organs | Class II |
| Atrial septal puncture sheaths | Class II |
| Intracranial drug-eluting stent systems | Class III drug-device combination product |
Please refer to the link below for details.
Refer from https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20230817153633135.html
If you have any questions about medical device in china,
Please contact us with the below.
info@jnmglobal.net
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