Japan Software as a medical device (SaMD)

The Government of Japan (GOJ) has steadily been taking measures to improve the regulatory review process for medical devices, including, recently, stand-alone medical software, or Software as a Medical Device (SaMD).  Still, Japan lags other countries in the digital health sector.  For example, the U.S. approves five times more SaMD products, such as those that utilize AI (artificial intelligence) and machine learning, than does Japan.

Recognizing this gap, the Ministry of Health, Labour and Welfare (MHLW) has taken several recent steps to promote early product commercialization of SaMD.  First, in November 2020, it launched a strategy called DASH for SaMD, or Digital Transformation Action Strategies in Healthcare for SaMD.  Then, in April 2021, it established an office dedicated to SaMD development, as did the Pharmaceutical and Medical Device Agency (PMDA), which is akin to the FDA in the U.S.  In addition, MHLW established a SaMD study group under one of its advisory councils, and – in collaboration with PMDA – set up an integrated contact desk to take inquiries on application criteria, regulatory affairs, and reimbursement.

Japan’s Cabinet approved in June 2021 its Basic Policy for Economic and Fiscal Management and Reform (known as “honebuto”), which specifically prodded the GOJ to promote the development and commercialization of SaMD.  While these policies are being implemented to support and encourage Japanese companies, U.S. firms with state-of-the-art SaMD products stand to also benefit - and thus should stay abreast of market trends and access prospects.

For more information, please contact Hiroyuki Hanawa at Hiroyuki.Hanawa@trade.gov or Akiko Sugiura at Akiko.Sugiura@trade.gov