Central Drugs Standard Control Organisation is, known as CDSCO, is
a regulatory body for the Indian medical devices industry, under the vittles of
the Drugs & Cosmetics Rules, 1945 and Drugs & Cosmetics Act, 1940. To
Import medical device into India is needs to have an import license which is
regulated by CDSCO. it’s the national regulatory body for Indian pharmaceutical
and medical devices.
Team Operon Strategist will help you in CDSCO Registration or DCGI
approval for your products as per the guidelines of CDSCO.
ALL IMPLANTABLE
DEVICES, MRI AND CT SCAN EQUIPMENT NOW REQUIRE IMPORT LICENSES
With the release ofF.No. 29/ Misc/ 03/
2021- DC( 28) on April 18th, 2021 the Central Drugs Standard Control Organization(
CDSCO) now requires the following medical devices gain an Import License
previous to importation.
- All Implantable Medical Devices
- CT Scan Equipment
- MRI Equipment
- Defibrillators
- PET Equipment
- Dialysis Machines
- X-Ray Machines
- Bone Marrow Cell Separators
- CLASSIFICATION OF MEDICAL DEVICES
The medical devices are classified into
the following 4 orders based on the risk involved in operation
- Class A – low risk
- Class B – low to moderate risk
- Class C – moderate to high risk
- Class D – high risk
The devices are further classified into
Surgical andNon-Surgical based on their invasiveness.
For more info go through
CDSCO
Import License for Medical Devices In India
CDSCO Manufacturing License for Medical Device
