Description of the figure H-1: displays a sample folder structure requirement for a medical device application in IMDRF TOC structure

Figure H-1 displays a sample folder structure requirement for a medical device application in IMDRF TOC structure. It shows that a folder name using a letter “m” followed by 6 numbers should be used as the “Dossier Identifier” or “License Name”.

Followed by, folder:

• License Name

Sub-folder:

• 1 REG ADMIN

Sub-subfolders:

• 1.01 Cover Letter
• 1.04 Application Form - Administrative Information
• 1.06 Quality Management System, Full Quality System or Other Regulatory Certificates
• 1.09 Pre-Submission Correspondence & Previous Regulator Interactions
• 1.14 Other Regional Administrative Information

Sub-folder:

• 2 CONTEXT

Sub-Subfolders:

• 2.4 Device Description
• 2.4.4 Reference & Comparison to Similar &-or Previous Generations of the Device

Sub-folder:

• 5 LABELLING

Sub-Subfolders:

• 5.01 Chapter Table of Contents
• 5.02 Product-Package Labels
• 5.03 Package Insert-Instructions for use
• 5.04 e-Labelling
• 5.05 Physician Labelling
• 5.06 Patient Labelling
• 5.07 Technical-Operator Manual
• 5.08 Patient File Stickers-Cards & Implant Registration Cards
• 5.09 Product Brochures
• 5.10 Other Labelling & Promotional Material