• 2026-09-21 02:52:44

In Japan, Software as a Medical Device (SaMD) within certification criteria is reviewed and certified by Registered Certification Bodies (RCBs). Any product that exceeds the definition of its generic name, established certification standards, or the range of equivalence to predicate devices is subject to be reviewed by PMDA for approval.
Recently, it has been discovered that several cases in which the main and additional functions of SaMD products exceeded the certification scope. PMDA published this notice to prevent the recurrence of similar inappropriate certifications by standardizing and clarifying the requirements for describing software functions (Reference 1).

• 2026-08-25 07:11:00

As general-purpose digital devices like smartphones and wearables become increasingly integrated into health monitoring, PMDA published the review guidance for home-use Software as a Medical Device (SaMD) intended to detect signs of disease and encourage users to seek medical consultation. It outlines the scope of the guidance, product description requirements, evaluation dossier, and key considerations for clinical study design, including clinical intention, design concept, clinical performance evaluation, and risk management. The summary is intended to provide an overview of the regulatory expectations for the development and evaluation of this type of SaMD and to facilitate understanding of the PMDA review approach.

• 2026-04-28 01:22:14

In alignment with the latest regulatory guidance on SaMD and cybersecurity for network-connected devices, the framework for managing ancillary network infrastructure (such as VPN gateways) has been refined. This includes an extensive definition of responsible matrices, lifecycle security maintenance, and the implementation of proactive security controls to mitigate cyber risks.

• 2022-07-26 11:13:22

MHLW announces evaluation items for medical devices that use new technology to speed up the approval process. This time evaluation items for Breast Cancer Diagnosis Device and SaMD with Behavior Change were announced.