[SHINSA]SaMD page updated (guide revised, seminar videos and materials published, consultation schedule updated)

The "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" (PMD Act) enforced on 25 November 2014, regulated medical device software intended to diagnose and treat diseases as medical devices in line with global harmonization efforts. Since then, many SaMD products have been developed and have obtained marketing approval.
To promote early practical use of innovative SaMD products, PMDA provides a consolidated set of information related to the approval review of SaMD products in this website. This website is planned to be updated as latest information is announced. For information on medical device certification, please see the website for third-party certified medical devices (in Japanese).

Determination Whether Software Qualifies as a Medical Device開閉

Under the PMD Act, software subject to medical device regulation is software (software function) that has an intended use as a medical device and has significant potential risk to the patient's (or user's) life and health when not functioning as intended. (Excluding those with little potential risk to human life and health (corresponding to a general medical device).)
For specific principles, please see the following notification.

Consultation on Qualification of Software as a Medical Device is integrated at Compliance and Narcotics Division, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW). If you would like to confirm whether your software scheduled for or under development qualifies as a medical device, please follow the instruction in the below website and apply for the Consultation on Qualification of Software as a Medical Device in Comprehensive Consultation for SaMD.

Please also refer to the SaMD Case Study Database provided in the MHLW website.