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Effective human factors and usability engineering assessment in the initial phase of medical device design can eliminate or reduce the likelihood of injury incidents caused by users' inability to correctly perceive and operate the device because of poor user interface designs. Currently, relevant authorities worldwide are attaching greater importance to the management of documents required for reviews before medical device becomes commercially available. Therefore, this study analyzed the existing medical device management system to clarify the principles associated with medical device human factors and usability engineering assessment currently employed in Taiwan. Relevant international standards are referenced to clarify the principles of medical device design and development to reduce user risks. Moreover, the inquiries and management of human factors and usability engineering studies and the reviews and requirements for production commercialization in the United States, the European Union, Japan, South Korea, China, and various international organizations were compared to provide a comprehensive outline of management principles in human factors and usability engineering for future medical device. Accordingly, a globally standardized review system can be established to accelerate the product development and upgrade of the medical device industry in Taiwan, thereby reinforcing its international competitiveness. [ABSTRACT FROM AUTHOR]