Phases of CDSCO Manufacturing license
Phase I – Applicant Registration
Phase II – Test License application
Phase III – Manufacturing license application
Pre-requisite:

Generic Name / Brand Name
Intended Use
Material of construction
Mode of application
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. Also, if client is having whole sale license or manufacturing license thenself-attested copy has to be submitted and in absence of any of these licenses then justification on company letter head stating the same.

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:

ForApplication 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. Then payment as per fee structure of CDSCO has to be done online. Download the legal pdf form. Put digital signature and then again upload this form for final submission of application. Once application is successful firm will receive mail from CDSCO.Application submitted will be moved to stage of In-process when review is in-process. Then either application can be approved or if any query raised then that query related revised documents or any justification for that have to be uploaded online against that query.

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.

After form filling, uploading of all documents to be done. Then payment as per fee structure of CDSCO has to be done online. Upload payment receipt on online poral then a legal form will be generated based on product information filled and transaction done. Download the legal pdf form. Once application is successful firm will receive mail from CDSCO.

Read More - Phases of CDSCO Manufacturing license
Contact details –
Phone no - 9325283428
Mail - [email protected]
If You Want Medical Devices Services Consultation For Following.

1. Medical Device Manufacturing
2. CDSCO Registration
3. FDA 510 k clearance
4. Continuous Improvement Program
5. Design Control Requirements
6. QMS Certification Services
7. Manufacturing Plant Layout Design
8. Primary Packaging Consultant
9. CE Marking Consultant
10. Combination Product
11. Medical Device Design And Development
12. Clean Room Design Consultant
13. ISO 13485 Certification
14. ISO 15378 certification
15. Medical Device Process Validation
16. 21 cfr part 820
17. 21 cfr part 210 and 211
18. DMF submission
19. CAPA Management
20. TURNKEY PROJECT CONSULTANT