Medical Device Division

 

 

# Frequently asked Questions on registration and Import of Medical Devices in India

#Minutes of the meeting of the experts committee to examine the Specification and Criteria for acceptance for Tests Performed on blood Glucose Test Strips and Analyzerbased  Glucose Reagent

# Frequently Asked Questions In - Vitro Diagnostic (IVD) Devices

# Organogram of Medical Device Division

# Clarification on Diagnostic kits/reagents

# Guidance Documents on common submission format for Manufacture of Medical Devices (Form-28) under CLAA scheme.

# Guidance Documents on common submission format for Registration (Form-41) (excluding notified IVD's), Import Licence (Form 10) (excluding IVD's) and Manufacture of Medical Devices(Form-28) under CLAA scheme. 

#Clarification for import of Pre filled syringes components Barrels plunger rod and stopper in unassembled

# Clarification for Import of Raw Material in bulk form in rolls/bundle (Sutures) for manufacture of finished product

# Clarification for import of non - notified medical Devices

# Minutes of Meeting of IVD Industry held on 07-08-2012 at CDSCO(HQ) New Delhi

# Guideline/ Clarification issued by CDSCO on Medical Devices

# Import Registration Certificates for Medical Devices Issued

# List of Licensed Indigenous Manufactures of Medical Devices,

# List of Notified Medical Devices 

# Medical Device Advisory Committe (MDAC) Orders

# General Formats - Medical device

# Draft Guidance Documents

# Guidance Documents

# Non- Compliance observed During Review Process of application for Registration & Import Licenses of Medical Devices

#Critical Diagnostics & Blood Products  

Scanned Copies