Japan Market Update: Guidelines and Q&A on Remanufactured Single-Use Medical Devices, Software as a Medical Device

Japan’s Ministry of Health, Labour and Welfare (MHLW) has published several updates regarding medical device registration and compliance. The releases include guidelines and questions and answers on remanufactured single-use medical devices, as well as updated guidelines on the applicability of software as a medical device (SaMD).

MHLW publishes guidelines and questions and answers on remanufactured single-use medical devices

The MHLW published a notification (link in Japanese) announcing the release of documents related to single-use devices (SUDs) that include the Post-marketing Safety Measures for Marketing Authorization Holders of Remanufactured Single-Use Medical Devices and a collection of questions and answers (Q&A). The Post-marketing Safety Measures for Marketing Authorization Holders of Remanufactured Single-Use Medical Devices explains the responsibilities of the Marketing Authorization Holder of the remanufactured SUD.

MHLW updates guidelines on the applicability of SaMD

The MHLW has revised parts of the Guidelines on the Applicability of Software as a Medical Device, provided in PSEHB/MDED Notification No. 0331-1 dated March 31, 2021 (also referred to as the “Applicability Notification”). The purpose of the update is to provide further clarification and elaboration on the determination of the eligibility of SaMD in Japan.

Notably, a new part 8 has been added to the guidelines to specify some points to note for software that does not fall under the category of medical devices and for raising awareness on the proper use of the software. For details, the revised guide is provided in PSEHB/MDED Notification No. 0331-1 dated March 31, 2023 (link in Japanese).