UL Japan Product Lineup

UL Solutions provides evaluation testing and certification in accordance with product safety standards and EMC standards, biocompatibility testing, reprocessing validation, packaging validation, and ISO 13485 audit registration services to manufacturers of medical devices, in vitro diagnostic medical devices, laboratory equipment, and testing/measurement equipment.

Medical device manufacturers need to demonstrate compliance with numerous regulations regarding electromagnetic compatibility (EMC), wireless performance, radio frequency (RF) exposure, and other safety and performance requirements to ensure product safety and market entry. UL Solutions provides comprehensive support and guidance from design concept to product completion, helping to avoid potential issues and reduce time to market.

Our company is one of the NRTLs (Nationally Recognized Testing Laboratories) recognized by the U.S. OSHA, and we are also a CB accredited testing laboratory certified by IECEE in the fields of medical electrical equipment and in vitro diagnostic medical devices. Additionally, we are an ILAC accredited testing laboratory registered with the International Accreditation Service, Inc. (USA). The evaluation reports and certifications we provide can be used for medical device and in vitro diagnostic medical device regulatory submissions in various countries.

IEC 62304 (JIS T 2304: Medical Device Software Software Life Cycle Processes) specifies the requirements for the life cycle processes of medical device software and serves as a requirement for obtaining regulatory approval in regions such as Europe, the United States, and Japan. Our company is accredited by the ILAC-accredited organization IAS in the United States for ISO/IEC 17025 certification of IEC 62304 (Medical device software – Software life cycle processes), and you can utilize the 62304 evaluation report with our support.

[Webinar Series on Medical Device Safety Standards from the Basics 2025] Session 2: Electromagnetic Interference/EMC Testing of Medical Electrical Equipment (IEC 60601-1-2) March 25, 2025 | Free | Online Technical standards for medical devices are complex and varied, including the IEC 60601-1 series and individual standards from the IEC 60601-2 series. In recent years, revisions to EMC standards have been made, and the transition period to the JIS standard JIS T 0601-1-2:2023 is approaching in mid-February 2026. In this webinar, as part of the introductory series on medical device safety standards for 2025, we will provide an overview of IEC 60601-1-2, explain electromagnetic interference testing, and discuss changes from the 4th edition to the 4.1 edition. Additionally, we will introduce some testing methods for basic standards that were requested in last year's survey. For more details and to register, please follow the link below.

We will be holding the "UL Solutions Seminar," which has received great acclaim every year, again this year. This time, we are pleased to welcome Mr. Keisuke Fujii as our keynote speaker, who will talk on the theme "The Cutting Edge of Quantum Computing: From Fantasy to Reality - The Potential for Innovation from Japan." Additionally, we have prepared 13 webinars that provide the latest information on standards, regulations, and technologies that are of particular interest across a wide range of fields. By registering for the webinars, you can watch the keynote speech at any time during the event period. We encourage you to take this opportunity to sign up. [Overview] ■ Date: November 14, 2025 (Friday) - December 12, 2025 (Friday) | Online ■ Participation Fee: Free You can check the list of webinars being held in the basic information (at the bottom of this page). For the dates and details of the webinars, please refer to the "Registration Page."

In domestic medical device regulations, comprehensive cybersecurity measures will be required starting April 2024. As a result, understanding and addressing security risks will be essential for the development of new products. This on-demand webinar will introduce the standard for cybersecurity in medical devices, IEC 81001-5-1, through a dialogue format with security experts, explaining terms and concepts. We hope this will help you understand the content of cybersecurity standards. The content is designed to address the specific interests of those responsible, blending perspectives on security and medical devices to be practically useful. --- For those who find security terminology difficult or the intent of the standards unclear, we will explain several key terms. This on-demand webinar will not be in a lecture format but will proceed through a dialogue between the questioner and the explainer. *For viewing methods and details, please refer to the PDF document "【On-Demand Webinar】 Cybersecurity for Medical Devices" or feel free to contact us.*

To sell medical devices in Brazil, product registration with ANVISA is required. However, before registering with ANVISA, you must demonstrate the conformity of the relevant products based on the INMETRO conformity assessment program. We have summarized the key points of the latest Ordinance No. 384 and the certification process concisely, so please access the "Related Links" below to assist you when considering entry into the Brazilian market.