Japan is the second largest medical device market in the world. Getting through the registration process and selling your product on the market is not an easy task.
This webcast will give an overview of the medical device registration process in Japan as well as provide tips to overcoming potential challenges in Japan’s regulatory pathway. Key topics discussed include device classification, PMDA consultation sessions, required documentation, device reimbursement, how to maximize foreign clinical data, and how to expedite product registration. The webcast will also focus on regulation updates, such as the new outcome examination system, and future trends in Japan’s medical device regulations.
View our Japan Medical Device Regulations webcast to learn more about these topics and more.
To view the webcast presentation slides in PDF format, please click on Japan Medical Device Regulations Updates 2014 Webcast Slides.
Presenter
Ames Gross, President and Founder of Pacific Bridge Medical.
Overview
- PMDA Consultations – What they are, how they work, and how much they cost.
- Device Classification – How classification is determined and the criteria that must be met for each classification.
- Product Registration – More third party inspections and the best ways to succeed.
- FMA – Recent changes.
- QMS – Recent changes.
- Overseas Clinical Data – Can it be used for medical device approval and what factors to consider.
- Japanese GCP – How to ensure your clinical trials meet Japanese GCP requirements.
- New Device Regulations – Changes regarding raw materials, cellular and gene therapy, and software.
- Device Reimbursement – Don’t register unless you can get decent reimbursement.
Pacific Bridge Medical can assist you with regulatory strategy and medical device registration in Japan, to help you obtain product approval and access to Japan’s medical market. We can also act as your Japanese designated marketing authorization holder (DMAH). For updated Japan medical market information and a full list of our services in the Japanese medical market, please click here, or contact us for more information.