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Regulatory Focus™ > News Articles > China Classifies, Reclassifies Dozens of Medical Devices After Review

China Classifies, Reclassifies Dozens of Medical Devices After Review

Posted 15 October 2012 | By Ansis Helmanis

Following a review conducted by its experts, China's State Food and Drug Administration (SFDA) notified provincial and municipal agencies on 12 September 2012 of the classification of 73 medical devices.

Nine devices were classified as Class III (implanted or life supporting devices); 41 as Class II (controls needed to ensure safe use); three as Class I (safety assured through routine administration); and 20 reclassified as non-devices. 

Examples of new classified products include:

  • Class III - devices for inhaled nitrous oxide delivery, ultrasonic bone surgery, cell sorters, and spine probes
  • Class II - cognitive correction software, MRI auxiliary stimulation systems, and pediatric head laser scanners
  • Class I - fixed postoperative supports for limbs, microbial probe processers, and non-contact wide angle viewing mirror
  • Non-regulated - automatic blood bag labelers, gauze counters, and sterile ice machines

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