The Chinese government’s State Council Executive Committee has approved updates (link in Chinese) to the country’s medical device regulatory system, bringing the long-awaited revisions closer to actual implementation.

The latest approval follows submission of proposed medical device regulatory revisions by the China Food and Drug Administration’s (CFDA) predecessor agency to China’s State Council Legislative Affairs Office in 2008.

Among anticipated revisions:

• Changes to medical device definitions and classification rules
• New measures to track risk and quality of device production
• Adverse event monitoring requirements
• Increased penalties for violations and noncompliance

Further details of the revised requirements as well as implementation dates and timeframes should be forthcoming. Hopefully the CFDA will allow adequate time for Chinese medical device market registrants to ensure compliance with any new requirements—especially given the possibility of harsher penalties for violations.

Stewart Eisenhart