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Medical Devices - FRANCE
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Competent Authority
Ethics Committee
Study Specific Requirements
National Legislation
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Competent Authority
Ethics Committee
Study Specific Requirements
National Legislation
Definitions
Name
Contact Details
Ethical Review – General
Single-Centre Studies - Ethical Review
Multi-Centre Studies - Ethical Review
Submission of Application
Submission Format
Language of Submission
Submission Fees
Timelines Ethical Review
Amendments/ Substantial Amendments (SA)
Safety Reporting
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