Following release of the the draft exemption list for manufacturer’s comments in May 2016, CFDA published the second wave exemption list for conducting clinical trials in China – there are an additional 267 Class II devices and 92 Class III devices. In comparison to the existing lists of which there were 488 Class II devices and 79 Class III devices – CFDA has definitely listened to the manufacturers and have included a significant amount of devices in the Clinical trial exemption list. This will result in reducing the amount of local trials in China.
Examples of devices included in the new exemption list are:
- a wide range of surgical instruments
- Silicone Breast implants
- Pen injectors
- Endoscopy and bronchoscopy devices
- Various ultrasound diagnostic imaging equipment
- IVF equipment for assisted reproduction
- Diagnostic platforms such as haematology analyzers
- A wide range of dental equipment and devices
Devices noted on the final list gain automatic exemption from conducting clinical trials in China. In thus, the manufacturer is able to meet the clinical requirements by providing the comparison table – mainly to compare the device to be registered and the substantial equivalent (SE) device (predicate in China) with justification that the devices to be registered has the same safety and performance as the predicate in China. This approach will significantly reduce the effort and cost for the manufacture to bring the devices into China market.
Click here for preliminary English language translation (Google translate) of the published exemption list.
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