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Draft Guidance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