China Updates Medical Device Trial Guidelines

Patient safety protections include enhanced sponsor monitoring requirements and additional requirements for patient informed consent.  The guidelines provide stricter sponsor monitoring requirements and strengthen the role of ethics committees in study design and monitoring.  The additional requirements for patient informed consent include the types of information that must be provided as well as acceptable methods for obtaining informed consent.

As China’s role as an exporter of medical products grows, the United States Food and Drug Administration (FDA) has strengthened its relationship with Chinese regulators. Among many initiatives, FDA has trained hundreds of Chinese inspectors in areas that include inspecting for good manufacturing practices and assessing the quality of data from sites that conduct clinical trials

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