Regulation and certification procedures

The regulation 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 for new medical devices that resulted in a problematic delay or device lag during the approval process. Initially, the Pharmaceuticals and Medical Device Agency (PMDA), founded under the jurisdiction of the Ministry of Health in 2001, evaluated all class III moderate to high-risk medical devices that could cause serious harm and class IV high-risk devices that could lead to fatalities. In the 2014 amendment, the government expanded the range of medical devices that third-party private organizations can certify. This included some class III medical devices. According to the fiscal year 2018 report from the PMDA, the device lag was reduced to 1.4 years compared to three years reported in fiscal 2009. The most recent amendment of the PMD 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. After the nationwide spread of the coronavirus disease (COVID-19,) the disease-related devices such as new respiratory apparatus or artificial heart and lung apparatus received fast track approval by the PMDA and the health ministry.

Research and development

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 software for diagnostic imaging using super magnifying endoscopes EndBRAIN, for example, was developed by Universities and Cybernet Systems Co., Ltd with the support of AMED. It was approved as the first domestic AI-equipped product for endoscopy in 2018 and released by Olympus for sale in March 2019. The average annual R&D expenditure of Japanese medical device manufacturers, however, showed a decline in recent years, amounting to 315 million yen in fiscal 2019, less than half compared to fiscal 2014.

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