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Strategic regulatory planning
As international harmonization and deregulation progress, we are now in the age when sophisticated medical devices are being developed in large numbers. Consequently, the process for approvals is becoming more complicated and specialized. Based on such circumstances of medical device development, MIC provides up-to-date support for strategic regulatory planning towards product approvals.
• Strategic planning of regulatory affairs towards product approvals
• Determination of application category (me-too, improved, new) of a medical device
• Determination of necessity of a clinical trial
• Evaluation of possibility of using overseas clinical trial data
• Evaluation of possibility of using overseas non-clinical data
• Review of available documents and listing additionally required documents
• Support for prior consultation with PMDA
• Preparation of cost estimate and time frame to obtain approval
