Clarification on China agencies’ redundancy reduction effort
This article was originally published in The Gray Sheet
Executive Summary
Plan for China's Administration of Quality Supervision, Inspection and Quarantine and its State Food and Drug Administration to reduce redundancies between them by requiring only one test, one report, one fee and one factory inspection, applies to eight specific device types (1"The Gray Sheet" Sept. 22, 2008, p. 8). Other device types were not affected by the problem. The eight types include: X-ray systems, hemodialysis systems, extracorporeal circulation tubes for blood purification, hollow-fiber dialyzers, heart-lung machines, electrocardiographs, pacemakers and condoms