Free Seminar: "Points to Note for Smooth Medical Device Testing and Certification, Explained by an Assessor"

The Japan Quality Assurance Organization (JQA) (Head Office: Chiyoda-ku, Tokyo; President: Hiroaki Ishii) will hold a free in-person seminar titled "Points to Note for Smooth Medical Device Testing and Certification, Explained by an Assessor" on August 7, 2026 (Fri) at Shinagawa Front Building (Tokyo Venue) and on August 21, 2026 (Fri) at Osaka ATC Green Eco Plaza (Osaka Venue).

To sell medical devices in Japan, procedures must be followed in accordance with the "Act on Securing Quality, Efficacy and Safety of Products, Medical Devices, Regenerative and Advanced Therapies, and Pharmaceuticals (PMD Act)."

This seminar will feature JQA assessors explaining in an easy-to-understand manner the points that often cause difficulties in electrical safety testing, EMC testing, and PMD Act certification. Please take this opportunity to attend.

Seminar Overview

Date and Time

[Tokyo Venue] August 7, 2026 (Fri) 13:30 - 17:00 (Reception opens at 13:00)

[Osaka Venue] August 21, 2026 (Fri) 13:00 - 16:30 (Reception opens at 12:30)

Seminar Format

In-person

*Not held online.

Capacity

[Tokyo Venue] 180 people

[Osaka Venue] 60 people

*Registration will close once capacity is reached.

*If there are too many applications, we may adjust the number of participants per company.

Participation Fee

Free

Content

* [PMD Act Certification] Flow of PMD Act certification and common stumbling blocks in reviews (inspections)

* [Safety Testing] Approach to evaluating IEC 60601-1:2005+A1:2012+A2:2020 and points that are frequently cited

* [EMC Testing] Commonalities and differences between IEC 61326-2-6:2025 and IEC 60601-1-2:2014+A1:2020

* JQA Services Overview

* Q&A

Lecturers

* Nobuto Watanabe, Assessor, Certification Department, Medical Device Certification Division, Center for Safety and Electromagnetic Compatibility

* Takanori Aida, Chief, Life Science Division, Safety Testing Department, Center for Safety and Electromagnetic Compatibility (Tokyo Venue only)

* Fumio Yamato, Manager, Medical Device Testing Division, Safety Testing Department, North Kansai Testing Center (Osaka Venue only)

* Kousei Shibata, Manager, Central EMC Testing Department

Target Audience

* Those involved in the design, development, regulatory/standards management of medical electrical equipment

* Those facing challenges with electrical safety testing and EMC testing

* Those who wish to learn about IEC 61326-2-6:2025

* Those facing challenges with PMD Act certification

Venue

[Tokyo Venue]

Shinagawa Front Building Meeting Rooms A & B

B1F, 2-3-13 Konan, Minato-ku, Tokyo 108-0075

>Access

>Floor Map

[Osaka Venue]

Osaka ATC Green Eco Plaza Seminar Room

West side, 11F, ITM Building, 2-1-10 Nanko-kita, Suminoe-ku, Osaka 559-0034

>Access to Osaka ATC Green Eco Plaza

>Directions to the Seminar Venue

Registration

Please apply from the information page below.

>Apply (JQA Website)

Notes for Attendees

* Recording or filming of the seminar is prohibited.

* We kindly ask that companies involved in certification/testing or consultants and support providers refrain from applying.

* Seminar content is subject to change without notice.

* Some content may overlap with seminars previously held by JQA.

* The seminar may be canceled due to unavoidable circumstances such as natural disasters. If cancellation is determined in advance, we will notify you by email.

* No certificate of attendance will be issued.

* No on-demand video distribution will be provided.

* Please arrive at the Tokyo venue after 13:00 and at the Osaka venue after 12:30.

* The seminar content will be the same at both venues.

* The seminar secretariat may take photos of the venue.

[Japan Quality Assurance Organization (JQA)]

Since its establishment in 1957, JQA has been a fair and neutral third-party conformity assessment organization supporting the development of Japan's manufacturing and service industries. Currently, it is a certification body with the largest number of management system standard audits in Japan (※), including ISO 9001 and ISO 14001, and also a calibration body that provides calibration of measuring instruments in the largest range of fields in Japan, supplying national measurement standards to industry. Furthermore, as a designated body for domestic and international laws, regulations, and certification systems, JQA provides a wide range of services, including electrical safety certification and testing for electrical products, medical devices, and automotive equipment, JIS mark certification, as well as testing and inspection of construction materials, and auditing and evaluation of corporate activities aimed at achieving goals such as carbon neutrality.

※ JQA research / as of the end of March 2026.