Regulatory requirements for medical devices in different Asian countries (India, China, and Japan)

Abstract

Since the use of medical devices is increasing globally, the market for them has recently begun to grow. For
the diagnosis and management of diseases, millions of patients rely on medical devices. The way that medical
devices are regulated differs from nation to country and is determined by each regulatory body. Medical devices
are controlled by the Pharmaceuticals and Medical Devices Agency and Ministry of Health, Labour and Welfare
in JAPAN, the National Medical Product Administration in China, and the Central Drug Standard Control
Organization in India. The laws of these nations, the International Medical Device Regulators Forum, and the
Medical Device Product Working Group were examined. Benefits of harmonising rules are also discussed.
Medical devices are thought to be a blessing for the health-care system because they are life-saving instruments.
Nevertheless, these devices have a number of negative side effects in addition to their therapeutic benefits. To
manage such negative impacts, a cohort vigilance system that worked well was required. Material vigilance had
been introduced as a result of this. A materiovigilance is an investigation and monitoring events that come about
as a result of using medical equipment. It handles more than just adverse events but also to bring for international
harmony, focusing on these goals, the guiding ideas, viewpoints, and methods. In addition, the instances that
have already occurred suggest that ongoing monitoring of medical equipment in use is necessary to safeguard
patients’ health. The existing guidelines for medical device regulation and the post-market vigilance framework
were looked at and addressed.