Aug 4, 2022

Japan’s Ministry of Health, Labour and Welfare (MHLW) has revised regulatory guidance related to several medical device and in vitro diagnostic (IVD) device policies.

The announcements include:

  • Revision to the online submission of notifications
  • Updated guidelines on package inserts for medical devices
  • Changes to software medical devices (SaMDs) covered by insurance

All links below are in Japanese.

Online submission changes for medical device and IVD registrants

First, the MHLW issued PSEHB/MDED Notification No. 0727-1 (dated July 27, 2022). The intention of this notification is to update policies and procedures related to how medical device and IVD device manufacturers submit online notifications (including those for the approval or permission of certain medical devices and IVD devices) to gain or maintain market access in Japan. As previously reported, applications and notifications for certain medical devices and IVD devices that were not permitted to be submitted online will start to be accepted. This online submission option remains accessible only to Japanese manufacturers and businesses.

The notification notably delayed the start date of the online submission of several forms. This notice also abolishes the previous notification regarding online submissions dated May 19, 2022.

Changes to medical device package insert requirements

Second, the MHLW issued several pieces of guidance regarding package inserts. PSEHB Notification No. 0721-1 (dated July 21, 2022) provides revised rules for digitized package inserts for medical devices and IVD devices. The MHLW also released PSEHB/PSD Notification No. 0721-1 (dated July 21, 2022), which is revised guidance regarding the handling of digitized package Inserts for pharmaceuticals, etc. subject to the emergency approval system. The intention of this revision is to update specific medical devices and IVD guidelines with details related to the emergency approval system established by Act No. 47 of 2022.

At the same time, the PMDA published Notice No. 0721001 (dated July 21, 2022) which outlines instructions for writing in the digitized form (XML or SGML) of package inserts of pharmaceuticals and medical devices, IVDs, etc. for emergency approval.

Updated insurance-related policies for SaMDs

Third, the MHLW has communicated changes to policy matters related to software medical devices (SaMDs) that manufacturers and distributors intend to be covered by insurance. Specifically, the communication outlines instructions for applicants who intend to submit requests for insurance coverage of these devices and plan to make minor modifications between the approval time and the start of manufacturing and sales.

Emergo by UL will post updates to these regulations as they become available.

Learn more about Japanese medical device regulations from Emergo by UL:

  • Japan PMDA registration and approval consulting
  • Japan MHLW Ordinance 169 quality system compliance support
  • Whitepaper: Transitioning to MDSAP for QMS compliance



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    Kathryn Burke