Technical File Fees

A. Guidance and Documentation Fees ( MDD/AIMD)  

Activity Class of Medical Device
Class 1 Class 1s/m Class 11a Class 11b Class 111
Technical File / Design Dossier
Preparation without NB coordination
1500 1500 2500 3000 3500
Technical File / Design Dossier
Preparation with NB coordination
1500 3000 3500 4500 5000
  Expected Timeline
  NA 45 Days 55 Days 75 Days 90 Days

 

B. Guidance and Documentation Fees ( IVD )

Activity   IVD Type / List
Self B (LR) B (HR) A
Technical File / Design Dossier
preparation without NB coordination
1800 2300 2500 3000
Technical File / Design Dossier
Preparing with NB coordination
NA 4000 5000 5500
  Expected Timeline
  45 Days 90 Days 90 Days 90 Days

 

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