The Medical Device Regulation for Humanoid Robotics: Does One Size Fits All?

Medical robots are dominating the healthcare institutions globally and demonstrate the increase of risk of sustaining injuries to human users due to the complexity of the robotic technology involved. The urgency of having a reliable, safe and effective robotic system has spurred the adoption of many methods within the engineering community. Even though these methods are quite well perceived by them, the role of regulatory system is as much required to ensure and maintain high standard of quality, safety and effectiveness of medical robotic. Malaysia on the same hand is under a progressive development of a rehabilitative NAO humanoid robot used as an intervention program for autism. Before a full-fledged robot based intervention program is being placed in our healthcare environment, a thorough research of the existing regulatory framework ought to be carried out. Hence this paper aims to outline the present medical device regulation and investigate its sufficiency in governing this cutting edge technology at the pre-market stage by benchmarking the United States medical device regulation.