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CDSCO_OperonStrategist_Professional_Presentation

A CDSCO Manufacturing License is typically valid for 5 years, after which renewal is required. With this license, companies gain legal authorization to manufacture, sell, and distribute medical devices in the Indian market. It enhances credibility, ensures quality assurance, and helps manufacturers build trust with hospitals, distributors, and consumers.<br><br>For full details on the process, visit:<br>https://operonstrategist.com/services/regulatory-approvals/cdsco-registration/cdsco-manufacturing-license

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CDSCO_OperonStrategist_Professional_Presentation

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  1. CDSCO Registration Guide Prepared by Operon Strategist Professional Regulatory Compliance Support

  2. About CDSCO • National regulatory authority for medical devices & drugs • Ensures safety, quality, and compliance • Mandatory for manufacturers & importers

  3. Why CDSCO Registration • Legal permission to sell in India • Builds trust with hospitals & clients • Ensures device safety & compliance • Needed for tender participation

  4. Device Classification • Class A – Low Risk • Class B – Low–Moderate Risk • Class C – Moderate–High Risk • Class D – High Risk

  5. Who Needs Registration • Manufacturers • Importers • Foreign Manufacturers • Authorized Indian Representatives

  6. Registration Process • 1. Device Classification • 2. Documentation Preparation • 3. Authorized Indian Representative (if applicable) • 4. CDSCO Portal Submission • 5. Review & Clarifications • 6. License Issuance

  7. Documents Required • ISO 13485 Certificate • Device Master File • Plant Master File • Free Sale Certificate (Imports) • Risk & Clinical Evaluation

  8. Why Operon Strategist • 12+ years regulatory experience • Expert documentation support • Fast & smooth approval processing

  9. Contact • Prepared by: Abhishek Dhole • Email: dhole7852@gmail.com • Company: Operon Strategist

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