China FDA to Revise Hundreds of Device Standards

China’s Food and Drug Administration plans to revise more than 300 standards by 2020, according to a new two-year plan for bringing the country’s medical devices and in vitro diagnostics up to international standards.

The standards will cover technical requirements for development, risk management, quality control and clinical trials.

The revisions are part of ongoing reforms including more stringent medical device standards, improved quality system management and oversight as well as improved inspections. CFDA also wants to encourage innovation within the country, and the agency said it will identify priority areas for innovative device development to meet unmet needs.