UL Japan Company Profile

The technical standards targeting medical devices are complex and varied, including the IEC 60601-1 series and individual standards from the IEC 60601-2 series. Additionally, in recent years, revisions have been made to the EMC standards. In this webinar, as part of the introductory series on safety standards for medical devices in 2025, we will provide an overview of IEC 60601-1-2, explain electromagnetic interference testing, and discuss the changes from the 4th edition to the 4.1 edition. We will also introduce some testing methods for basic standards that were requested in last year's survey.

We will be holding our popular webinar series on the introduction to safety standards for medical devices again this year, enhancing the content as always. In its third year, this time we will add new themes and incorporate the latest information, providing clear explanations of the overview of standards related to medical devices, as well as safety testing and evaluation points. We encourage you to use this as internal training for those involved in development, regulatory affairs, and quality control at medical device manufacturers. This webinar serves as an introduction to the "Webinar Series on Understanding Safety Standards for Medical Devices from the Basics," where we will introduce the regulations and standards for testing and evaluation related to safety for medical devices in major countries. We will also delve into the standards concerning usability and cybersecurity that will be applicable in Japan in 2024. We hope this will help you understand and prepare the necessary items for testing and evaluation in advance, thereby reducing the burden of applications as much as possible.

When shipping wireless-equipped products to countries in the Asia region, it is necessary to meet the regulatory requirements for each destination. These requirements vary significantly due to the radio wave regulations of each country and region, and in recent years, there have been changes to regulations and revisions to the application processes. This seminar will serve as a revised version of the radio wave regulation seminar conducted in 2022 for countries in the Asia region, following up on the previous content while also providing information on the latest trends and regulatory updates. This seminar is intended for those planning to expand their products to various Asian countries, as well as for those who are already operating in the region, providing an opportunity to organize information. Additionally, the second part of the seminar will include the latest trends from major countries outside of Asia. It will also be useful for obtaining the latest information. You can check the details of the seminar by clicking the "Details & Registration" button below.