Japan continues to lag behind the United States in the registration of AI-based Software as a Medical Device (AI-based SaMD), particularly for products that continuously update after commercialization. Under Japan’s current regulatory framework, the Pharmaceuticals and Medical Devices Agency (PMDA) does not yet accommodate AI software that continuously changes its performance after approval.
In Japan, software products that are “fixed” during development and do not continuously evolve after approval may qualify for registration if there is a comparable predicate product already approved in Japan. In these cases, companies may be able to pursue a certification application pathway (Ninsho), depending on whether the software’s intended use and functionality are considered substantially equivalent to an existing certified product.
However, if no similar functionality exists among already approved or certified products in Japan, or if the software introduces novel functions, the product generally must undergo a PMDA approval review (Shonin, not Ninsho). Such applications are often associated with a more difficult regulatory process and likely will require a Japanese clinical study to demonstrate safety and effectiveness for product approval.
The distinction between “fixed” AI and continuously learning AI remains an important consideration for companies planning to commercialize AI-based SaMD products in Japan. According to current practice, AI systems that sequentially change performance after commercialization are difficult to evaluate under existing PMDA review standards because the software itself may evolve over time. The PMDA does not want to take this unknown risk. As of now, it is not possible to register continuously updated AI products in Japan. As Japan’s PMDA becomes more familiar with AI technology, hopefully this will change.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.