In terms of revenue, Olympus Corporation and Terumo Corporation are the largest domestic medical device manufacturers. Olympus generated more than half of its revenue from the endoscopic solutions segment. The company dominates the gastrointestinal endoscope field with about 70 percent of the global market share as of 2022. Terumo’s current main revenue stream is the cardiac and vascular segment, followed by sales from the medical care solutions segment.
The review period of PMDA has aligned with that of the FDA in recent years due to those changes in the certification processes. Nonetheless, new devices produced in Japan were still certified 2.3 years later than the corresponding US products, according to the 2020 PMDA report. This was mainly attributable to the delay in initiating and succeeding in development projects due to the lack of capital strength and resources in the domestic medical device industry.
Regulation and certification procedures
The regulations for medical devices in Japan was first enacted in the 2002 Pharmaceutical Affairs Law. It was amended and renamed the Pharmaceutical and Medical Device (PMD) Act in 2014. The 2014 amendment aimed to shorten the lengthy certification and legislature procedures that resulted in a problematic delay in the practical use of new medical devices approved by the Pharmaceuticals and Medical Device Agency (PMDA) compared to the US Food and Drug Administration (FDA). A subsequent amendment of the Act in 2019 targeted to further cut the pre-marketing review period for innovative products and introduced an early approval system for medical devices that treated rare illnesses.The review period of PMDA has aligned with that of the FDA in recent years due to those changes in the certification processes. Nonetheless, new devices produced in Japan were still certified 2.3 years later than the corresponding US products, according to the 2020 PMDA report. This was mainly attributable to the delay in initiating and succeeding in development projects due to the lack of capital strength and resources in the domestic medical device industry.
Japan Agency for Medical Research and Development (AMED)
To facilitate the development of innovative medical devices domestically, the government established the Japan Agency for Medical Research and Development (AMED) in 2015. AMED promotes the research and development (R&D) of medical devices that integrate artificial intelligence (AI), Internet of Things (IoT) technologies, robotics technologies, 3D or 8K resolution imaging technologies, as well as other technologies. The Medical Imaging Projection System (MIPS), for example, was developed by Mitaka Kohki Co., Ltd., Kyoto University, and Panasonic Corporation with the support of AMED. MIPS is the world’s first surgery assisting system that operates with projection mapping. It was approved by the PMDA in 2019 for manufacture and sales.
