📄 Documents Required for Medical Device Registration (CDSCO India)
To register and import medical devices into India, the following documents are required based on the Medical Device Rules, 2017 (MDR 2017) under CDSCO – Central Drugs Standard Control Organization:
🩺 1. Applicant / Importer Documents
✅ Cover Letter & Authorization Letter
✅ Copy of Wholesale Drug License (Form 20B/21B or 42)
✅ Certificate of Incorporation / Company Registration
✅ Undertaking for Authorized Indian Agent (if applicable)
✅ Power of Attorney (Notarized & Apostilled)
🌍 2. Manufacturer Documents
✅ Free Sale Certificate (FSC) issued by the Country of Origin
✅ ISO 13485 Certificate (Quality Management System)
✅ Manufacturing License / GMP Certificate
✅ Details of Manufacturing Site (address, layout, and production flow)
✅ CE Certificate (if applicable)
⚙️ 3. Device-Specific Technical Documents
✅ Device Description & Intended Use
✅ Device Classification (Class A, B, C, or D)
✅ Labeling Information as per CDSCO guidelines
✅ List of Variants / Models
✅ Test Reports (if applicable)
✅ Risk Analysis & Essential Principles Checklist
✅ Device Master File (DMF)
✅ Plant Master File (PMF)
📬 4. Additional Documents (if applicable)
✅ Import License (Form MD-15)
✅ Registration Certificate (Form MD-14)
✅ Clinical Evaluation / Performance Data (for certain devices)
✅ Shelf Life & Storage Conditions
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