CDSCO License Application Procedure - Ozg Healthcare Co.

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the Food and Drug Administration of the United States (FDA) it is a plan announced by the way government to bring all medical devices, including implants and contraceptives, under the view of the Central Drugs and Standard Control Organization (CDSCO). CDSCO manufacturing license of medical devices is covered under CLAA scheme and signed for granting by State Licensing Authority may be considered for approval by CLAA with the condition that licensee shall fulfill requirements of Medical Devices Rules. Manufacturing of notified medical devices comes under the CLAA scheme for sale in India, in manufacturing license in Form -28 is required under drugs and cosmetics rule is required for  grant of manufacturing license.

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 any 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.

Procedure:

First online form has to be filled and all above required documents have to be uploaded. In online form details of manufacturing company like complete corporate address, contact details like email and contact No., fax No., name of authorized person name, ID proof number, Company type (Ltd, Pvt. Ltd etc.), email id for registration, password, alternate email id etc.

Once form submitted, preliminary approval mail will be received from CDSCO then another mail stating hard copy submission will be received. Hard copies of all uploaded documents have to be couriered to CDSCO address with specific subject mentioned in that mail.

 Hard copies submitted will be verified with online submitted information and documents and then CDSCO will approve application registration. Mail will be received from CDSCO after approval to verify log in details and hence online account will be generated.

If rejection of application happened from CDSCO for submitted application then mail will be received stating reason for rejection then revised document have to be submitted during reapplication and same process have to follow again. 

Phase II – Testing 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. 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.

Application submitted will be moved to stage of In-process when review is in-process. If query compliance is acceptable then approval of test license will be received and email related to same will be send by CDSCO. Then after visiting portal cover and permission letter can be downloaded.

Steps -
  1.  User should register on the portal with verified login credentials ,to access the portal for Online Form Submission.
  2. After log in on the portal ,user is required to fill all the mandatory fields of the User Profile i.e. Profile Details which includes member details, wholesale license details and contact details.
  3. It is mandatory to fill the complete User Profile ,otherwise user will not be able to apply for application through the portal.
  4. After successful updation of User Profile, user can submit application into the system.
  5. User can now move to fill Permission Owned/Historical Data or Form Submission.
  6. In Permission Owned/Historical Data:
  7. Why should I give my Permission Owned/Historical Data???
  8. If user is holding permissions (Registration Certificate and Import license ) in hard copy issued in the year 2012 or later , then user should fill Permission Owned/Historical Data first .
  9. For Registration Certificate:
  10. If user is applying for Endorsement case or Re-registration case for Registration Certificate (RC), then user needs to fill the previous details related to RC first before proceeding to apply for form 40 under Form Submission Menu.
  11. For Import License:
  12. If user is applying for Endorsement case or Renewal case for Import License, then user needs to fill the previous details related to import license first before proceeding to apply for form 8 under Form Submission Menu.
  13. In Form Submission:
  14. In form submission ,user can apply for Form 40 or Form 8.
  15. Form 40 is applied for getting Registration Certificate Number.
  16. Form 8 is applied for getting Import License Number.
  17. Application for Form 40:
  18. User can apply for Form 40 for three cases i.e. Fresh, Endorsement and Re-registration.
  19. Before applying for Endorsement or Re-Registration case ,user must fill the previous RC details first in Permission Owned/Historical data menu.
  20. User should fill all the required (mandatory) fields to fill the form.
  21. After filling the form till first preview , user can modify the form.
  22. Once user moves to the checklist ,user will not be able to modify the form .So, user should provide all correct entries.
  23. If user do not fill the complete application in one go, then application will be saved in Saved As Draft mode.
  24. To view application in Saved As Draft mode, click on Menu Form SubmissionSaved Applications.
  25. Application for Form 8:
  26. User can apply for Form 8 for three cases i.e. Fresh, Endorsement and Renewal.
  27. Before applying for Endorsement or Renewal case,user must fill the previous import license details first in Permission Owned/Historical data menu.
  28. User should fill all the required (mandatory) fields to fill the form.
  29. After filling the form till first preview , user can modify the form.
  30. Once user moves to the checklist ,user will not be able to modify the form .So, user should provide all correct entries.
  31. If user do not fill the complete application in one go, then application will be saved in Saved As Draft mode.
  32. To view application in ,Saved As Draft mode, click on Menu Form SubmissionSaved Applications.
  33. If user fill the complete application in one go, then application will be Submitted to CDSCO.
  34. To view Submitted Application, click on MenuForm Submission Submitted Applications.
  35. If application is approved by CDSCO, then it will be visible under Approved Applications tab.
  36. To view Approved Application, click on Menu Form SubmissionApproved Applications.
  37. If application is rejected by CDSCO, then it will be visible under Rejected Applications tab.
  38. To view Rejected Application, click on MenuForm Submission Rejected Applications.