CE MARKING FEES




Consultation and Documentation Fees.

Activity Class of Medical Device
I Is/m IIa IIb III
Assistance in making Technical file / Design Dossier *** *** *** *** ***
Assistance in making Technical file / Design Dossier
for Animal Origin Devices
    *** *** ***
Assistance in making Technical file / Design Dossier
for Radiation Emitting Devices
    *** *** ***
Assistance in making Technical file / Design Dossier
for Medical Software
    *** *** ***
Assistance or Support in closing NB reviewer comments *** *** *** *** ***
Instruction for use and Label Review (gap analysis) *** *** *** *** ***

IS/M: indicate about class one devices with a sterilisation or with a measuring function (the measurement of anybody function/ parameter of the patient)

For “***”, Please contact us for proposal, Please mention about the product in detail ( Technical name of the product and its intended use and details of models), so that we can send you the proposal

Important:
  • travelling charges are extra at actual.
  • OBL / PLM will be charged 30 % less
  • Active Implants Technical file / Design Dossier assistance charges will be quoted separately
  • IVD Technical file / Design Dossier assistance charges will be quoted separately
  • Payment - 50 % advance, 30% before submission and balance after approval.
  • Method of communication -by e-mail and by telephone ( as per the suitability).
  • Language for communication – English.

Contact us

A1-101, Ankur,
Near Cipla Foundation,
Warje, Pune- 411058

E mail :- info@avscertification.com
Telephone :- +91 - 9881946595



Design & Developed By : Logic Palace Systems and Softwares
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