January 10, 2023
Japan’s Ministry of Health, Labour and Welfare (MHLW) published a number of updates. First, MHLW published the Notifications on the Sale of Used Medical Devices. Second, the MHLW released a Notification on the Simplification of Procedures for Online Applications. Third, the MHLW published a Q&A on the Performance Evaluation Tests for Certain Diagnostic Medical Devices. And fourth, the MHLW has released PSEHB/MDED Notification 1130-1, which partially revises the Standardized Format for Clinical Trial Requests, etc.
Notifications on the Sale of Used Medical Devices
The MHLW has issued PSEHB/MDED Notification No. 1213-1, dated December 13, 2022, (link in Japanese) which relates to the sale of used medical devices by the distributor to another person.
Specifically, this outlines details for the notification to the Marketing Authorization Holder (MAH) of the medical device. Notably, the MAH and the distributor must comply with the Processing of Notices Concerning the Sale or Rental of Used Goods by Manufacturers and Distributors (Notification No. 1018-1 dated October 18, 2013).
Notification on Simplification of Procedures for Online Applications
The MHLW has released PSEHB/MDED Notification No. 1213-2, dated December 13, 2022, (link in Japanese) on the simplification of application procedures using digital technology. Notably, this includes the procedures for confirming the originals of application forms when the online submission begins, including Application for License to Manufacture and Market Medical Devices/In Vitro Diagnostics (Form 9) and Application for Medical Device/In Vitro Diagnostic Manufacturing Business Registration (Form 63-2).
Q&A on the Performance Evaluation Tests for Certain Diagnostic Medical Devices
The MHLW has published a collection of questions and answers (Q&A) for performance evaluation tests for diagnostic medical devices using existing medical image data, etc. without additional invasion or intervention. This document is in line with the notification PSEHB/MDED Notification No. 0929-1, dated September 29, 2021 (link in Japanese) on the handling of performance evaluation tests of diagnostic medical devices using existing medical image data, etc. without additional invasion or intervention.
Partial Revision of the Unified Format for Requesting Clinical Trials
The MHLW has released PSEHB/MDED Notification 1130-1, dated November 30, 2022, (link in Japanese) which partially revises the Standardized Format for Clinical Trial Requests, Etc. issued on July 10, 2018. Notably, changes were made to several forms for company clinical trials/post-marketing clinical trials and physician-initiated clinical trials, including those for reporting serious adverse events and malfunctions of medical devices used in clinical trials and post-market clinical trials.
Emergo by UL will post updates to the guidance as they become available.