CDSCO Manufacturing license
                     CDSCO Manufacturing license
Operon Strategist
www.operonstrategist.co +91-93702 83428
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Phases of CDSCO Manufacturing license
1. Phase I – Applicant Registration
2. Phase II – Test License application
3. Phase III – Manufacturing license application
Pre-requisite:
4. Generic Name / Brand Name
5. Intended Use
6. Material of construction
7. Mode of application
● Study of device details and Classification of medical device on the basis of notified product list of CDSCO.
● Class of device helps in determining application form to be applied and also application fees.
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Phase I – Applicant Registration:
In thisphase after applying client can have an active account on CDSCO Online System for Medical 
Devices registration site.
Document requirements:
Documents required for this phase are address proof like certificate of registration or certificate of 
incorporation or Import-export certificate or MTNL/BSNL bills of corporate site, ID proof of authorized 
person, this person can be any person apart from management team who will be authorized to all types 
of registration. 
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Phase II – Test License application
This license is required to have permission to manufacture small quality of device for testing, evaluation, 
demonstration and training of personnel.
Procedure:
For Application on online portal, form has to be filled with device related information like generic name, 
brand name, class of device, category of device, packaging configuration, shelf life, sterile / non-sterile, 
intended use, product description, accessories and model details if any. After form filling, uploading of all 
above documents to be done. 
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Phase III – Manufacturing license application.
This license is required to have permission to manufacture device for commercial purpose.
Procedure:
For Application on online portal, form has to be filled with device related information like generic name, 
brand name, class of device, category of device, packaging configuration, shelf life, sterile / non-sterile, 
intended use, product description, accessories and model details if any.
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Thank You.
For More Information Contact Us
www.operonstrategist.com
[email protected]
+91-93702 83428
Call / Whatsapp  - 9325283428 www.operonstrategist.com