ABSTRACT

Clinical trials constitute a critical aspect of regulatory affairs in the biomedical device industry. Class III devices, which are defined as highly regulated, high-risk instruments that may pose significant risk or injury, must go through pre-marketing approval.1 These include central life-saving devices such as pacemakers, joint implants, and cardiac catheters. Before a device becomes approved by health authorities and merchandisable for use in humans, it must be proven to be harmless to patients and be able to deliver its expected benefits.2 Clinical trials are the primary means of obtaining this assurance. Within the growing biomedical device industry in

Asia, running proper clinical trials will guarantee the safety and efficacy of newly developed medical devices.