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Flow of Medical Device Approval and Sales

Preliminary meeting(s)
Consultation meeting Necessary industry permission
Regulatory submission
MAH license*2
Manufacturer for labeling*3
Q & A, presentation  
Review for approval, GCP inspection, GMP audit
Application for reimbursement
Reimbursement Necessary industry permission
Retailer license *4
Retailer license


Please refer to our publication for more detailed information.

"The Japan Medical Device Market and Regulatory Report"

Tokyo time

Product Registration

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