Medical Device Registration Wants to Ensure Quality of Data by CFDA


As part of its effort to ensure the quality of data in medical device filings, CFDA has published documents to overhaul the regulation of how medical devices are developed and manufactured in China. In its effort, CFDA applies its clinical trial data monitoring push for medical devices. As planned, CFDA will be creating a team to conduct its long-awaited on-site inspections of medical device clinical trial sites. This team once formed will start informing clinical trial device companies of its plans for on-site inspections.

This means that CFDA will run its own inspections to assess the quality and authenticity of data throughout the medical device registration and approval process.

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