UL Japan Official site

[6-Part Introductory Seminar Series] Session 1: Introduction to Regulatory Compliance for Medical Devices - Overview of Domestic and International Regulations and Introduction to Related Testing Standards

UL Japan

Overview of Medical Device Regulations and Key Points of Safety Testing and Evaluation! This is the first installment of a six-part online seminar that explains the overview of standards related to medical devices and key points of safety testing and evaluation. ---- Session 1: Introduction to Medical Device Regulatory Compliance - Overview of Domestic and International Regulations and Introduction to Related Testing Standards In the regulatory submission for medical devices, it is required to demonstrate safety in use through multiple tests and evaluations applicable as non-clinical trials. However, conducting tests and evaluations in each field necessitates a deep understanding of the related standards, which can be time-consuming in preparing the submission. Additionally, standards are constantly updated with new versions and releases, requiring medical device manufacturers to invest effort in compliance. This seminar will explain the regulatory overview of medical device submissions in the United States, Europe, and Japan, and introduce the relevant testing and evaluation standards associated with medical device regulatory submissions. You can check the details and agenda of the seminar by clicking the "Details & Registration" button below.