Software as a Medical Device Regulatory Pathway
PMDA regulatory pathway for software classified as medical devices. This establishes specific approval and certification procedures for software-based medical devices in Japan.
Manufacturers and sponsors placing medical devices on the Japan market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗