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.
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
How Operon Strategist Assist you in CDSCO Application process?
When it comes to CDSCO medical device license process, Operon Strategist is a medical device consulting company. We are 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.
Read More - CDSCO Guidelines & Medical Device Registration
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Contact details –
Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
Phone no - 93702 83428
Mail id – enquiry@operonstrategist.com
If You Want Medical Devices Services Consultation For Following.
- Medical Device Consulting
- cdsco registration
- FDA 510k Clearance
- ce mark medical device
- CDSCO Manufacturing License
- CDSCO import license
- TURNKEY PROJECT CONSULTANT
- medical device manufacturing
- iso 15378 certification
- 21 cfr part 210 and 211
- ISO 13485 Medical Device Consultant
- Primary Packaging Turnkey Project Consultant
- Clean Room Design Consultant
- manufacturing site conceptualization
- Market Analysis and feasibility for Medical Devices
- manufacturing plant layout design
- medical device design and development
- DMF file submission guideline
- 21 cfr part 820
- qms certification services
- capa management
- design control requirements
- medical device process validation
- combination product
- continuous improvement program
- Medical Device Compliance & Regulatory Services
- Cdsco India authorized agent for medical device
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