Software as a Medical Device (SaMD) Regulation
Dedicated regulatory pathway for software-based medical devices within Japan's medical device approval framework.
🔖 Status: pending-implementation
This reform is part of the PMDA's ongoing programme to modernise and strengthen the Japan medical device regulatory framework. Monitor the official source for updates on timelines, consultation opportunities, and implementation guidance. Where relevant, begin assessing potential impacts on your existing registrations, technical documentation, and compliance timelines so your organisation is prepared when the reform takes effect.
View official source ↗