Abstract
Class III medical devices are defined as those which are implanted inside the human body and applied to maintain normal life and retain original tissue or organic functions. Because these devices are associated with high risk, their effectiveness and safety should be strictly monitored and clinically investigated. The aim of clinical investigation of these medical devices is to ensure the acceptability of their effectiveness and safety levels. On designing the clinical trial, the investigator should determine the indices to assess the effectiveness and safety of medical devices, select reasonable data‐analyzing methods, and pay attention to several other issues. Although some guidelines on specific class III medical devices have illustrated those aspects in detail, there is still no comprehensive report that details all those principles and methodologies. This article aims to summarize the common features among the instruction principles and provide technological support for the clinical study of class III medical devices.
Highlights
As class III medical devices present the highest risk among medical devices for patients in China, the management and control of those devices is much more stringent than for other devices[1]
Sometimes even preclinical animal model tests are not performed for grafted products such as demineralized bone matrix (DBM), because the FDA does not regard this as a necessary procedure[3]
This article aims to summarize the common features among the instruction principles, to compare the differences, and to provide technological support for the clinical trials and assessments of class III medical devices
Summary
Clinical Trial Assessment Principles of National Class III Medical Devices in China. Class III medical devices are defined as those which are implanted inside the human body and applied to maintain normal life and retain original tissue or organic functions. Because these devices are associated with high risk, their effectiveness and safety should be strictly monitored and clinically investigated. On designing the clinical trial, the investigator should determine the indices to assess the effectiveness and safety of medical devices, select reasonable data-analyzing methods, and pay attention to several other issues. This article aims to summarize the common features among the instruction principles and provide technological support for the clinical study of class III medical devices
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