CDSCO Registration Consultant _ Operon Strategist_
                     CDSCO Registration Consultant | Operon 
Strategist 
www.operonstrategist.co +91-93702 83428
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CDSCO Registration Consultant 
Central Drugs Standard Control Organization, commonly known as CDSCO is a regulatory body for the 
Indian medical devices industry, under regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 
1945. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for 
Indian medical devices and pharmaceuticals. It is a licensing authority which approves any new chemical 
entity (drug) to import to India. Every nation in the world has its own dedicated governing body under the 
ministry of health to look after every aspect of pharmaceutical and medical devices. The CDSCO is 
responsible for regulating the registration & sale of notified medical devices in India.CDSCO controlled 
and governed by Directorate General of Health Services which comes under the ministry of health and 
family welfare Government of India. The headquarter of the Central Drugs Standard Control Organization 
(CDSCO) is located in New Delhi, India. It has six zonal offices, four sub-zonal offices, thirteen Port 
offices and seven laboratories spread across the country.
CDSCO Roles
● Approval of new drugs and clinical trials.
● Import CDSCO registration & licensing.
● Licensing of blood banks, vaccines and some medical devices.
● Amendment to Drugs & Cosmetics Act and rules.
● Participation in WHO GMP certification schemes.
● Grant to test license, personal license, NOC’s for export.
● Testing of drugs by central labs. Click here for latest list of laboratories
CDSCO Guidelines & Medical Device Registration
Step 1: Check if the product you wish to register is on the Notified Medical Devices and IVDs list.
Step 2: Contact an authorized agent, having a license for manufacture, distribution and/or wholesale 
license for sale can make an application for grant of import license for the medical device to the Central 
Licensing Authority
We at Operon Strategist walk with you throughout the process to help you get the required 
license smoothly. Contact us today
Step 3: Next step is to submit the application and specified fees for the process.
Step 4: After examination of documents furnished with the application and on the basis of the inspection 
report, if an inspection has been carried out, the Central Licensing Authority may, on being satisfied, 
grant license in Form MD-15
Step 5: License can be granted without clinical investigation if free sale certificate is been issued for any 
medical device by any of the National regulatory or other competent authority of countries like Australia, 
Canada, Japan, EU Nations, or the United States.
Step 6:  If medical device imported from countries other than mentioned above (in step 5), license for 
Class C and Class D medical device can be granted after clinical investigation for safety and 
effectiveness.
Step 7: If medical device imported from countries other than mentioned above (in step 5), license for 
Class A or Class B medical devices may be granted after its safety and performance has been 
established through published safety and performance data, It can be granted on basis of clinical 
investigation and free sale certificate from the country of origin.
Step 8: In case of an investigational medical device or new in vitro diagnostic medical device, the 
applicant should obtain prior permission for it through “form MD-27 or Form MD-29” from the Central 
Licensing Authority, without such prior permission medical device license may not be granted.
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