Chapter 6 - Regulations of medical devices in Japan and China

Abstract

A medical device is defined as an instrument or apparatus used for diagnosing, treating, or preventing diseases in humans or animals, or for affecting the structure or functions of their bodies. Medical devices in Japan are governed by the Pharmaceuticals and Medical Devices Agency and Ministry of Health, Labor, and Welfare, while in China, they are regulated by the State Food and Drug Administration and Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), which ensure their protection and effectiveness while also protecting human health and life. Public health programs, rules, and legislation are the responsibility of the Ministry of Health. Regulatory authorities and entities face significant challenges in ensuring the protection, efficiency, and effectiveness of medical devices. The current study provides an overview of medical device classification, regulatory authorities, and labeling requirements in Japan and China.