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United StatesJapan PMDA/MHLW Medical Device Regulatory Requirements
This course provides an overview of Japan’s regulatory framework for medical devices under the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW)
From device classification and pre-market pathways to Quality Management System (QMS) compliance, labelling, and post-market surveillance, you will gain the knowledge necessary to navigate the Japanese market. You’ll also explore the role of local representation, foreign manufacturer registration, and Japan’s participation in international harmonization efforts.
Our eLearning is a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
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Our experts possess a wealth of industry experience acquired over years of practical application, and in addition, they demonstrate a combination of unwavering passion and a proven aptitude for training.
Our Training Specialist
Eoin Philip Kelly
Our Instructor
Michelle Keane
Course Overview
Japan PMDA/MHLW Medical Device Regulatory Requirements
At the end of this short course, successful learners will be able to:
- Understand the Japanese medical device regulatory framework, including the role of MHLW and PMDA
- Identify device classification rules and associated pre-market pathways
- Apply requirements for Foreign Manufacturer Registration and the role of Marketing Authorization Holders (MAHs)
- Recognize Quality Management System (QMS) and Good Manufacturing Practice (GMP) requirements in Japan
- Understand post-market obligations, including vigilance reporting and re-examination/re-evaluation systems
- Navigate Japanese labelling, language, and advertising regulations
- Review Japan’s role in MDSAP and international regulatory harmonization
This course is for individuals or organizations who want to understand Japan’s PMDA/MHLW Medical Device Regulatory Requirements.
Successful completion of the course examination will entitle each Learner to receive a digital Certificate of Completion.
In order to successfully complete this course, each Learner will need to:
- Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
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