[Fujisoft Inc. Free Webinar] Comprehensive Guide to Cybersecurity Measures for Medical Devices in Japan, the US, and Europe – From legal regulations in Japan, the US, and Europe to related security requirements such as CRAs and the three ministries' two guidelines, explained in an easy-to-understand manner.｜Event｜A portal supporting medical device development

[Fujisoft Inc. Free Webinar] Comprehensive Guide to Cybersecurity Measures for Medical Devices in Japan, the US, and Europe – From legal regulations in Japan, the US, and Europe to related security requirements such as CRAs and the three ministries' two guidelines, explained in an easy-to-understand manner.

2026.8.18

This free webinar provides a clear and concise explanation of the overall regulatory landscape, commonalities, and differences in medical device cybersecurity measures in Japan, the United States, and Europe.
As we move forward with domestic operations, we will address questions such as, "What additional measures should we take to prepare for overseas expansion?"
This presentation will cover JIS T 81001-5-1, as well as FDA and European regulations, CRAs, and 3 ministries and 2 guidelines, highlighting the potential for utilizing deliverables created for domestic use and providing practical tips for global expansion.

【program】
1. Cybersecurity Response in Japan: From the Pharmaceuticals and Medical Devices Act to JIS T 81001-5-1, this section explains the requirements and key points for compliance in Japan. 2. What kind of cybersecurity response is required in the United States?
Focusing on the FD&C Act, Section 524B, and FDA guidance, this section explains the differences from domestic practices and points to note when implementing them. 3. What kind of cybersecurity measures are required in "Europe"?
This session will explain the overview of European regulations, including the MDCG document, the differences from domestic compliance, and points to note when complying. 4. Are you familiar with these laws and guidelines? We will explain the overview and compliance points of other laws and regulations related to medical devices, such as CRA, 3 ministries and 2 guidelines, and HIPAA. [Date and Time]
Wednesday, September 9, 2026 16:00 – 17:00
[How to hold the event]
Online Zoom Webinar
[How to apply]
Please apply here .
[Participation fee]
Free [Details]
https://medtecjapan.com/medtecwebinar/5992/
[Contact Information]
Fuji Soft Inc. Medical Device Seminar Secretariat E-mail: medical_dev_contact@fsi.co.jp