Description: CDSCO registration or CDSCO licence can be obtained by the process of CDSCO online
registration on the portal.
CDSCO stands for Central Drugs Standard Control Organisation (which comes under the Ministry of Health and
Family Welfare), which is headquartered in Delhi and has 6 zonal offices in India namely at Mumbai, Kolkata,
Chennai, Ghaziabad, Hyderabad and Ahmedabad and various other sub-zonal offices. It is the national
regulatory body for products like cosmetics, drugs,medical devices, etc.
Different divisions of the CDSCO are as below:
1.) Medical device division ( Drugs )
4.) Clinical Trial on medical devices division
Who can Apply
All manufacturers, either of Indian or foreign origin can apply for the CDSCO
licence.In case of foreign manufacturer license will be granted to the manufacturer and the Indian
counterpart of the manufacturer will act as it’s Indian Representative. The Indian representative of the
manufacturer must have a valid state drugs license under Form 20-B/21-B or Form 42 ( applied under Form 41 )
as per the latest guidelines released by CDSCO.
SClassification of medical devices as per regulations:
All types of medical devices are divided into 4 classes by the Medical Device Rules 2017, in 4 main
1. Class A ( least risk )
2. Class B ( Moderate risk )
3. Class C ( Moderate to high risk )
4. Class D ( High risk )
Class A products are further divided into 2 categories to ascertain if CDSCO
license or CDSCO registration is applicable on the product:
a.) Class A ( non sterile and non measuring ) products come under registration scheme.
b.) Class A ( Sterile or measuring ) products require license.
This brings us to the conclusion that products which are under class A ( sterile or measuring ), Class B,
Class C and Class D require a license from CDSCO.
Documents Required for :
A.) CDSCO registration for Class A products ( non-sterile and non-measuring )
1. Drugs license of importer ( Required only for foreign manufacturer )
2. Free sales certificate ( Required only for foreign manufacturer )
3. ISO certificate ( Required only for foreign manufacturer )
4. List of products to be registered.
5. Basic details about the product ( example: storage temperature, shelf life, model number, etc.) , etc.
B.) Class A ( sterile or measuring ), Class B, Class C and Class D
1. Plant Master File ( PMF )
2. Device Master File ( DMF )
3. Manufacturing process flowchart.
4. Labels and user manual.
5. Design verification and validation.
6. Stability validation data.
7. Challan of the government fee paid, etc.
CDSCO online registration for Class A products ( non-sterile and non-measuring )
- Generation of login Credentials.
- Registration of Indian / foreign manufacturer
- Registration of importer ( in case of import only )
- Addition off product details
- Submission of details to CDSCO
- Grant of registration.
Timeline : CDSCO registration process will take 1 day after the documents
are submitted to us.
Validity : Validity of CDSCO online registration is perpetual i.e. no end date and requires no renewal.
Note : After the registration is completed, a unique file number is generated, which has to be mentioned on
the product / packaging, in case of registration there is no certificate
CDSCO license :
- Identifying the class of the medical device.
- Making groups as per the guidelines mentioned as per CDSCO guidelines.
- Creation of login credentials for the manufacturer.
- Collection of documents from the overseas manufacturer.
- Collection of documents from Indian importer.
- Checking and vetting of documents as per the rules.
- Payment of government fees.
- Submission of Application online.
- Clearing of queries ( if any )
- Audit of the firm.
- Clearing of queries ( if any ) after the audit.
- Grant of license
- Generation of CDSCO certificate.
Timeline : Approx 6-8 weeks after submission of application.
Validity : It is granted for 5 years initially and has to be renewed after that by paying the government
Note: 1.) In case of CDSCO import license, AUDIT OF THE FOREIGN MANUFACTURER IS NOT CONDUCTED, and rest of
the procedure remains the same.
2.) License number mentioned on the CDSCO registration certificate has to be mentioned on the products /
3.) Test license is also required in case of Indian manufacturers.
Role of Sun Consultants & Engineers as CDSCO
As CDSCO registration consultants, our job is to ensure that the tiring
procedures that we have listed above become a cake-walk for you. Right from the beginning i.e. from the
stage of collection of documents from the foreign manufacturers or preparation of documents for the Indian
manufacturer and following up with the department for grant of license is under our scope.
We are one of the most experienced CDSCO consultants in the field of
medical products,we provide apex quality of services possible to all our national and international clients.