CFDA is proposing to exempt 22 types of Class II medical devices. The list of Class II medical devices covered by the draft includes endoscopic spinal surgical instruments, insulin pens and ultrasound bone densitometers. CFDA has provided a description of each type of device. The regulator has provided similar details for the six Class III medical devices it wants to exempt from clinical trials.
Publication of the proposal comes one year after CFDA last shared a draft list of medical devices to be exempted. That proposal, which came into force in September after minor changes, affected the status of 276 Class II and 92 Class III medical devices. CFDA first proposed exempting certain medical devices from clinical trials in 2014. That original list covered 488 categories of Class II devices and 79 types of Class III products.
The latest list of devices eligible for exemption is open for comment until June 20.
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