Catharina Klein
Research expert covering Japan
Medical device industry in Japan - statistics & facts
The term medical devices encompasses a wide range of products from diagnostic equipment such as x-ray apparatus and computer technology (CT) scanners, and therapeutic equipment such as catheters, to general equipment and supplies such as dental materials and surgical gloves.
While the United States dominates the market, Japan ranks as the fourth-largest producer of medical technology in terms of revenue. In recent years, therapeutic equipment and devices had the highest sales share in Japan, both for domestic products and imports.
The domestic demand for medical devices is steadily increasing, likely due to the rapidly aging population. Accordingly, there is a growing demand for devices that can help improve the quality of life of the elderly population such as mobility aids, home healthcare devices, and assistive technologies.
However, new devices were still certified about 2.3 years later in Japan compared to the corresponding US products in recent years. This was mainly due to the lack of capital strength and resources in the domestic medical device industry. Most medical devices that were newly approved by the PMDA were generic medical devices as well as improved medical devices without clinical data.
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.
The domestic demand for medical devices is steadily increasing, likely due to the rapidly aging population. Accordingly, there is a growing demand for devices that can help improve the quality of life of the elderly population such as mobility aids, home healthcare devices, and assistive technologies.
Regulation and certification procedures
The Pharmaceutical and Medical Device (PMD) Act was enacted in 2014, aiming 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). 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.However, new devices were still certified about 2.3 years later in Japan compared to the corresponding US products in recent years. This was mainly due to the lack of capital strength and resources in the domestic medical device industry. Most medical devices that were newly approved by the PMDA were generic medical devices as well as improved medical devices without clinical data.
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 of medical devices that integrate artificial intelligence (AI), Internet of Things (IoT) technologies, robotics technologies, and 3D or 8K resolution imaging 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.
