The Japanese Regulatory System for Medical Devices
This course begins by outlining the historical background of Japan’s Regulatory System for Medical Devices, including a detailed overview of the necessary company and manufacturing prerequisites to market medical devices in Japan, relevant product standards and classifications, various application routes for market approval, and the necessary preparations for completing submissions.
This course also offers the added element of lending crucial insight into Japanese culture, which can help learners establish good working relationships with regulatory authorities in Japan.
Note: The laws were recently updated on 25 November 2014
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Upon successfully completing this course, trainees will be able to:
- Comprehend and define the working fundamentals of the Japanese Regulatory System for Medical Devices, which includes:
- Background of Japan’s Regulatory System for Medical Devices
- Company prerequisites to market medical devices in Japan
- Manufacturing prerequisites to market medical devices in Japan
- Relevant product standards and classifications
- Application routes for market approval
- Preparation needed after completing a submission
Regulatory Affairs Associate, Regulatory Affairs Manager, Quality Assurance Associate, Quality Assurance Manager, Quality Assurance Engineer, Manufacturing Engineer, Supply Manager, Purchasing Manager, Design Engineer, Validation Engineer, Electrical Safety Engineer, Internal Auditor, Lead auditor, Pre-Clinical Affairs Director, Clinical Project Manager, Export Manager, and R&D Engineer involved in the Japanese registration and compliance process are welcome to enroll in this course.
Learners should have a basic understanding of both the principles outlined in the GHTF documents (now IMDRF) and the principles explained in the series of courses under SID N25 GHTF/IMDRF: “Regulatory Model for Medical Devices.”