CDSCO registration consultants | guidelines – Operon Strategist

CDSCO Registration Overview

Central Drugs Standard Control Organization, commonly known as CDSCO is a regulatory body for the Indian medical devices industry, under regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian medical devices and pharmaceuticals. It is a licensing authority which approves any new chemical entity (drug) to import to India. Every nation in the world has its own dedicated governing body under the ministry of health to look after every aspect of pharmaceutical and medical devices. The CDSCO is responsible for regulating the registration & sale of notified medical devices in India.CDSCO controlled and governed by Directorate General of Health Services which comes under the ministry of health and family welfare Government of India. The headquarter of the Central Drugs Standard Control Organization (CDSCO) is located in New Delhi, India. It has six zonal offices, four sub-zonal offices, thirteen Port offices and seven laboratories spread across the country.

CDSCO Roles

• Approval of new drugs and clinical trials.
• Import CDSCO registration & licensing.
• Licensing of blood banks, vaccines and some medical devices.
• Amendment to Drugs & Cosmetics Act and rules.
• Participation in WHO GMP certification schemes.
• Grant to test license, personal license, NOC’s for export.
• Testing of drugs by central labs

CDSCO has released new lists of notified medical devices and IVD devices, amended in June 2018. This lists covers all medical devices and IVD products. New notification of CDSCO includes the list of more medical devices that would be regulated by 1st May 2020. Follow our updates on Linkedin for the latest information and keep yourself informed about CDSCO Regulatory news and alerts. You can also contact us for any assistance or for a specific query.

How Operon Strategist Assist you in CDSCO Application process?

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When it comes to CDSCO medical device license process, Operon strategist makes the lengthy process easy and smooth with the best technical team working for you, along with excellent assistance, timely responses and affordable fees structure. Extensive experience in Regulatory consulting, medical device certification makes Operon strategist best regulatory Consultant. Contact us for all types of medical device consulting services and we will be always there to assist you.

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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 
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20. qms certification services 
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26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device