Provisional Translation (as of November 2023) *PSEHB/MDED Notification No.0930-1
PSEHB/CND Notification No.0930-1
September 30, 2022

To: Directors of Prefectural Health Departments (Bureaus)
Director of the Medical Device Evaluation Division,
Pharmaceutical Safety and Environmental Health Bureau,
Ministry of Health, Labour and Welfare(Official seal omitted)
Director of the Compliance and Narcotics Division,
Pharmaceutical Safety and Environmental Health Bureau,
Ministry of Health, Labour and Welfare(Official seal omitted)

Handling of revision of Japanese Industrial Standards concerning requirements for usability
engineering of medical devices
With regard to the application of “Standards for Medical Devices Specified by the Ministerof Health, Labour and Welfare pursuant to the provisions of Article 41, Paragraph 3 of the Act
on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical
Devices” (Ministerial Notification No. 122 of 2005; hereinafter referred to as “EssentialPrinciples”) pertaining to usability engineering of medical devices, "Concerning the Handlingunder the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticalsand Medical Devices in Accordance with the Establishment of the Japanese Industrial Standards
for the Application of Usability Engineering to Medical Devices" (PSEHB/MDED Notification
No. 1001-1 and PSEHB/CND Notification No. 1001-5, Joint Notification of Director of theMedical Device Evaluation Division and Director of the Compliance and Narcotics Division,
dated October 1, 2019; hereinafter referred to as “2019 Notification”) indicates the handling ofthe Japanese Industrial Standard “JIS T 62366-1:2019, Medical devices－Part 1: Applicationof usability engineering to medical devices”.
*This English version of the Japanese Notification is provided for reference purposes only. In the eventof any inconsistency between the Japanese original and the English translation, the former shall prevail.

JIS T 14971, Medical devices－application of risk management to medical devices, which isthe normative reference standard of JIS T 62366-1 has been revised, which also clarifies theapplication to usability and other relevant area. Following the revision of JIS T 14971, JIS T
62366-1:2019 was also revised to JIS T 62366-1:2022 (hereinafter referred to as “revised JIS”).
In response to this revision, the handling in the “Act on Securing Quality, Efficacy and Safetyof Products including Pharmaceuticals and Medical Devices" (Law No. 145 of 1960; hereinafterreferred to as the “Act”) has been stipulated as follows. Please inform the relevant organizations
under your supervision. This notification shall be effective as of October 1, 2012, and the “2019notification” will be abolished in accordance with the application of this notification.
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1. Confirmation of compliance with Essential Principles(1) The market authorization holders of the medical device, persons with special approval forforeign-manufactured medical device or foreign manufacturers of designated speciallycontrolled medical devices (hereinafter referred to as “MAH”) shall establish a system toverify compliance with the usability related requirements specified in Article 9 and Article
16, etc. of the Essential Principles for the medical devices to be marketed after March 31,
2024 (hereinafter referred to as "end of the transition period") with conformity to therevised JIS.
Necessary measures, such as revision of procedures, shall be taken to ensure conformity
to the revised JIS by the end of the transition period.
(2) Other than the revised JIS, the compliance with Article 9 and Article 16 etc. of the Essential
Principles may be confirmed by conformity to the appropriate internationally used
standards, etc. When applying for new approval or certification (including applications forpartial changes in approval and applications for partial changes in certification; hereinafterreferred to as “application for approval”), explain the appropriateness of using thesealternative standards, etc.
(3) The MAH who applies for approval or certification of a specially-controlled medical
device or controlled medical device on or after the day following the end of the transition
period shall confirm the conformity of the medical device according to the systemestablished in (1) above. The conformance to the revised JIS shall be explained in theattached data of the application for approval.
(4) When submitting a marketing notice on or after the day following the end of the transition
period, conformity with the system established in (1) above shall also be confirmed.

2.

The MAH shall conduct activities based on the revised JIS for the product realization
specified in Article 26 and design and development specified in Article 30 to 36 of theMinisterial Ordinance on Standards for Manufacturing Control and Quality Control for
Medical Devices and In-Vitro Diagnostics (MHLW † Ministerial Ordinance No. 169 of2004) and shall appropriately record and store the confirmation of compliance.
In addition, appropriate explanations must be provided by presenting data at the requestof the person authorized to investigate pursuant to the provisions of Article 23-2-5,Paragraph 7 or Article 23-2-23, Paragraph 4 of the Act.

†The term “MHLW” refers to the “Ministry of Health, Labour and Welfare.”