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CDSCO Registration Online | Process, Documents & Compliance

Apply for CDSCO Registration online for drugs, cosmetics, and medical devices. Step-by-step guide on process, documents, and approval timeline.

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CDSCO Registration Online | Process, Documents & Compliance

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  1. CDSCO Certification Drugs, Cosmetics & Medical Devices www.diligencecertification.com

  2. What is CDSCO? Regulatory Authority Governs Approval Central Drugs Standard Control Organisation under Ministry of Health & Family Welfare Registration, import, and quality control of drugs, cosmetics, medical devices Mandatory Process Required before launching, importing, manufacturing, or distributing in India

  3. Ramesh's Challenge The Problem Mumbai pharmaceutical start-up owner attempting to register pain-relief balm Confronted with complex terms and procedures CDSCO Registration Cosmetic licence Medical Device Registration CDSCO portal navigation

  4. BIS Certification Role Quality Standards Market Credibility Regulatory Compliance Builds consumer trust and product credibility in Indian marketplace Supports regulatory submissions for packaging materials and quality compliance Bureau of Indian Standards ensures quality and safety across industries www.diligencecertification.com

  5. Three Key Certification Three Key Certification Types Types Drug Licence Mandatory for manufacturing or selling drugs under Drugs and Cosmetics Act, 1940 Cosmetic Licence Required for therapeutic claims; ordinary cosmetics need Rule 135 notification Medical Device Registration Class A & B: state level; Class C & D: CDSCO registration required

  6. CDSCO Workflow Portal Register as Applicant Create account, select applicable form Upload Documents Product dossier, lab reports, GMP certificates Pay Fees Online payment with transaction screenshot Track and Respond Real-time tracking with prompt query responses

  7. Portal Analogy "Think of the CDSCO portal as a railway reservation system. You reserve (register), attach your documents (passengers' IDs), pay the fare (fees), and then track the train's arrival and any delays (queries from CDSCO)."

  8. Common Pitfalls to Avoid Classification Mismatch Incomplete Dossier Medical device filed as cosmetic gets rejected Missing expiry-date declarations delay approvals Solution: Classify correctly (Class A–D) Solution: Double-check every form section Expired Certificates Inconsistent Nomenclature Lab reports expiring within weeks get rejected Different product names across documents Solution: Use fresh certificates Solution: Maintain consistency

  9. Success Timeline Before Result Months of delays due to regulatory confusion Weeks, not months to market 1 2 3 With Expertise Streamlined process from specification to approval

  10. Ready for CDSCO Success? Expert Navigation Navigate documentation, classification, BIS standards, and portal submissions Mistakes are expensive - get it right the first time Drug launches Cosmetic brand registration Medical device approvals

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