After China State Council Order #650, The Regulations on Supervisory Management of Medical Devices, CFDA issued many supporting provisions on medical device registration, IFU and labeling, supervision of manufacturing and distribution. Besides these major device regulation changes, CFDA is also undergoing major organization changes.
The new China regulation updates simplify the approval process for Class I products and re-registration, adopted risk-based approach, extended license from 4 years to 5 years, and responded to the industry with many positive changes.
One change that resulted in a lot of discussions and concerns from industry, especially international device manufacturers, is the new clinical trial requirements for imported devices. The new CFDA regulations require more Class II and Class III imported devices to conduct clinical trials in China. But the China clinical trial can be exempted if (I) The medical device is a product having definite working mechanism, finalized design and mature production processes, while there have been similar medical devices of similar specifications already applied clinically for many years without severe effect and its regular usage would not be changed; (II) The safety and effectiveness can be proven through non-clinical assessment; (III) The safety and effectiveness of the medical device can be proven through the analysis and evaluation by using the data obtained from the clinical trial of similar product or during clinical application. The CFDA also published a catalogue of devices that clinical trial requirement is exempted, which include 488 Class II and 79 Class III devices.
Since all these regulations are rather new, how to interpret and implement these regulations and its impacts to the industry still remain to be seen. However, as China is one of the largest and fast growing device markets, companies need to move quickly to foresee and prepare for these impacts.
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