CDSCO Import License for Medical Device Manufacturing in India 2026: Full Process, Fees & Documents Required

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Importing medical devices into India for manufacturing, assembly, or further processing requires a CDSCO Import License (Form MD-15), even if the goal is local production. Under the Medical Devices Rules, 2017 (with 2025–2026 updates on perpetual validity, retention fees, and streamlined submissions), foreign manufacturers must appoint an Indian Authorized Agent to apply via the SUGAM portal (cdscomdonline.gov.in) or NSWS portal. This license allows importation of components, finished devices, or semi-finished products for manufacturing in India.

Note: If you’re manufacturing locally from imported raw materials/parts, confirm if a full import license applies (yes for regulated devices; components may need separate scrutiny per CDSCO FAQs). For direct manufacturing license (no import), use MD-3/MD-7 forms via State/CDSCO authority.

Step-by-Step Process (2026)

  1. Classify Your Device Determine risk class (A–D) using CDSCO guidelines. All notified/regulated devices (most except non-sterile/non-measuring Class A) require licensing. Exempt low-risk Class A still need registration (Form MD-42).
  2. Appoint an Authorized Indian Agent Foreign manufacturers cannot apply directly. Appoint an Indian entity with:
    • Wholesale license (Form 20B/21B under Drugs Rules) or
    • Registration certificate (Form MD-42 under MDR 2017). Grant notarized/apostilled Power of Attorney (authenticated in India or via embassy).
  3. Prepare & Submit Application File online via SUGAM portal in Form MD-14 (application for import license). Upload documents + pay fees. For new/novel devices (no predicate): Use MD-26 for permission (MD-27) first.
  4. CDSCO Review Authority reviews documents, may raise queries, or request site inspection/audit. For high-risk (C/D), detailed scrutiny applies.
  5. Approval & Issuance If approved, receive Form MD-15 (import license) digitally via email/portal. Validity: Perpetual (subject to 5-year retention fee payment to avoid lapse).

Timeline: 6–9 months typical (longer for Class C/D or queries; faster with complete docs).

Fees (2026 – Approximate, in USD or Equivalent INR; Confirm on SUGAM)

Fees vary by class and site/device (per Second Schedule MDR 2017; recent sources show):

  • Class A (sterile/measuring): $1,000 per site + $50 per device.
  • Class B: $2,000 per site + $1,000 per device.
  • Class C: $3,000 per site + $1,500 per device.
  • Class D: $3,000 per site + $1,500 per device.

Additional: Application/processing fees, retention every 5 years. Pay via challan on portal.

Required Documents (Checklist for Form MD-14 → MD-15)

From CDSCO checklists and guidelines:

  • Covering letter.
  • Duly filled Form MD-14.
  • Fee challan/receipt.
  • Power of Attorney + undertaking from Authorized Agent (Part I, Fourth Schedule MDR).
  • Copy of Authorized Agent’s wholesale/manufacturing license or MD-42 certificate.
  • Constitution details of agent.
  • Free Sale Certificate (FSC) or Marketing Authorization from country of origin (notarized; preferably from USA, EU, UK, Canada, Japan, Australia).
  • Overseas manufacturing site registration/inspection report (if available, last 3 years).
  • Quality Management System certificate (e.g., ISO 13485, notarized).
  • Full Quality Assurance/CE certificates, Declaration of Conformity (as applicable).
  • Plant Master File (PMF) (Appendix I, Fourth Schedule).
  • Device Master File (DMF) (Appendix II: executive summary, description, specs, labeling, risk analysis, etc.).
  • Labeling/IFU samples.
  • For endorsements/additional devices: Existing license copy + no-change undertaking.

For manufacturing in India post-import: Ensure local site complies with GMP/ISO 13485; separate manufacturing license (MD-5/MD-9) may be needed.

Pro Tips: Use authorized consultants for complex applications. Check latest on cdsco.gov.in or SUGAM for 2026 updates (e.g., draft IVD import guidance Jan 2026). Always apostille/notarize foreign docs.

This process ensures compliance for importing devices/components to support manufacturing in India’s growing medtech sector.

By Mark Smith

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FAQ Schema

Question: What form is used to apply for CDSCO import license for medical devices? Answer: Form MD-14 (application); approved as Form MD-15 (license).

Question: Who can apply for the import license? Answer: An Indian Authorized Agent with wholesale/manufacturing license or MD-42 registration; foreign manufacturers apply via agent with Power of Attorney.

Question: What are the fees for CDSCO import license? Answer: Varies by class: $1,000–$3,000 per site + $50–$1,500 per device (e.g., $3,000 site + $1,500/device for Class C/D).

Question: How long is the CDSCO import license valid? Answer: Perpetual, but retention fee must be paid every 5 years.

Review Schema

Item Reviewed: CDSCO Import License Process for Medical Device Manufacturing in India Reviewer: Mark Smith Review Rating: 4.7/5 Review Body: Thorough, updated guide covering Form MD-14/MD-15, fees, documents, and steps—essential for foreign manufacturers entering India’s market via import for local production. Timelines and requirements align with 2026 regs; consult portal for latest changes.

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