CDSCO Application Process| Operon Strategist

 

CDSCO Application process of India’s Central Drugs Standard Control Organization (CDSCO) has published several notices since mid-March in response to the ongoing pandemic. These address new measures to expedite access to devices intended to prevent or treat COVID-19, to safeguard supply of other critical IVDs, and to reduce the exposure of CDSCO staff to the SARS-CoV-2 virus.

The CDSCO Application process involves the development of the online licensing system for multiple stakeholders like Industry applicants, CDSCO officials from HQ, Zones, Subzones, Port offices, Investigators, medical practitioners. 

The system will provide an online interface for Applicants to submit applications, upload supporting documents, respond to queries from CDSCO officials and track their CDSCO Application process status. It will also enable CDSCO officials to process the applications, generate note sheet, and raise queries and issue approvals / permissions online. The purpose of the document is to specify in detail the Processing of applications of medical devices by the regulatory authority (CDSCO and SFDA).

Priority applications are to be processed within seven days. As part of the expedited CDSCO Application process, data requirements (e.g., for clinical performance evaluations) may be condensed, deferred, or waived on a case-by-case basis.

CDSCO Application process

1. An application shall be made to the Licensing Authority in Form 40, either by the manufacturer himself, having a valid wholesale License, for sale or distribution of drugs or by his authorized agent in India either having a valid License to manufacture for sale of a drug or having a valid wholesale License for sale or distribution of drugs.
2. DETAILS TO BE CAPTURED IN FORM 40: The authorized signatory name, designation, department, along with the complete address of the Company. 
3. i) Authorized Signatory: The person authorized preferably Director approved by the Board of Directors in case of company or by the proprietor in case of proprietorship firm. The application to accompany affidavit in respect of authorized person or the Power of Attorney in the name of the authorized person.

How to apply Cdsco?

To view Submitted Application, click on Menu Form Submission Submitted Applications. If application is approved by CDSCO, then it will be visible under Approved Applications tab. To view Approved Application, click on Menu Form Submission proved Applications.

Cdsco registration process

After submitting the Registration Form, Check Registered email for E-mail Verification. Submit ID proof, Undertaking, Address Proof Document in hard copy to CDSCO office. Registration will be approved by CDSCO only after evaluation of the submitted documents. Check your registered email id for all communications.

Manufacturers of medical devices, cosmetics, IVDs, are attracted to the Indian market due to the reliance of it on the imports. However the challenge is that the regulatory body in India is currently at its infancy and rules may be updated within short periods. The general timeline followed by the CDSCO for the various process of approval, trails, applications, can be found on CDSCO timelines.

Read More - CDSCO Application process

Visit Us - Medical device consulting

Read More Article - 

1.Orthopedic Implants Manufacturing

2.Dental Implants Manufacturing

3.Blood Collection Tubes Manufacturing

4. How to start the Manufacturing of Disposable Syringes?

5. disposable syringe manufacturers

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

    

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device