CANADIAN 4-TIER RISK-BASED DEVICE CLASSIFICATION SYSTEM
This article was originally published in The Gray Sheet
Executive Summary
CANADIAN 4-TIER RISK-BASED DEVICE CLASSIFICATION SYSTEM under development by the Canadian Medical Devices Bureau, according to bureau staffers. The system would divide medical devices into two groups -- one for in vitro diagnostics and another for all other medical devices -- and would establish four levels of regulatory oversight based on risk assessment for each category.