Japan Medical Devices Regulatory Strategy
Japan Medical Device Registration
Japan medical device registration can be a slow and cumbersome process because of the very strict regulations in Japan and the high costs of doing business there. Determining your medical device classification, putting together the dossier, and answering the Pharmaceuticals and Medical Devices Agency's (PMDA) questions require a strong attention to detail.
Without medical device product reimbursement, your product will not sell in Japan. Which reimbursement class should you apply for and when does a new reimbursement category make sense? This is just one example of Japan medical device regulations you will need to consider.
Japan Medical Device Regulations
If your medical device is a riskier product, doing a Foreign Manufacturer Accreditation (FMA), Quality Management Systems (QMS) audit, and other requirements will need to be met before you can aquire Japan medical decive registration.
For more information on issues regarding Japan medical device regulations, please see the following PBM publications and/or contact us to discuss your specific needs.
- Japan Medical Device Regulatory Updates 2013
- 2013 Japan Business Culture
- 2012 Japan Medical Device Product Registration and Regulatory Updates
- 2011 Strategies for Success in China, Japan, and India
- 2011 Japan Medical Device Updates
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