The Japanese Regulatory System for Medical Devices
This revealing and highly detailed course will quickly have you on the path to the land of the rising sun. Although contrary to some beliefs, it should be comforting to know that if everything is timed properly and all necessary preparations are done, registration in Japan is really quite straightforward.
Starting with the historical background of Japan’s medical device regulatory system, this course will take you through company and manufacturing prerequisites to market a medical device in Japan, relevant product standards and classification, various application routes for market approval and preparation needed after completing the submission.
You will also gain crucial insight into understanding the Japanese culture of perfection and etiquette, which will help you greatly in establishing a good working relationship with the regulatory authorities in Japan.
Note: The law were recently updated on November 25, 2014
Upon completion of this course, trainees will be able to correctly and successfully comprehend and define the working fundamentals of the Japanese Regulatory System for Medical Devices including:
- Background of Japan´s Medical Device Regulatory System
- Company prerequisites to market a medical device in Japan
- Manufacturing prerequisites to market a medical device in Japan
- Relevant product standards and classification
- Application routes for market approval
- Preparation needed after completing the submission.
Regulatory, marketing and quality assurance managers involved in the Japanese registration and compliance process.
Understand the basic principles as outlined in the GHTF documents (now IMDRF) and explained in the certification program on the GHTF/IMDRF Regulatory Model for Medical Devices.