China Food and Drug Administration (CFDA) recently issued the Working Procedures for the Audit of Quality Management System for Domestic Class III Medical Devices Registration (Interim). The Procedures stipulates the work linkage between CFDA technical evaluation institutions and provincial regulatory departments, the contents of the system auditing, the system auditing documents submitted by registration applicants, the auditing timeline, the auditing results, the feedback of auditing results, and the relation between auditing results and product registration evaluation.

For more information, visit: http://www.sfda.gov.cn/WS01/CL0845/121049.html