How Foreign Manufacturers Can Get CDSCO Import License to Manufacture in India 2026

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Get CDSCO Import License to Manufacture – Foreign manufacturers looking to import medical devices into India whether for direct sale, distribution, local assembly, or further manufacturing—must secure a CDSCO Import License (Form MD-15). Under the Medical Devices Rules, 2017 (with 2025–2026 updates including perpetual validity, retention fees, and provisions for subsequent importers/brand endorsements), foreign entities cannot apply directly. They must appoint an Indian Authorized Agent (or Authorized Indian Importer) to handle the entire process via the SUGAM portal (cdscomdonline.gov.in or NSWS portal).

This license enables legal importation of finished devices, components, semi-finished products, or raw materials for manufacturing in India. If the end goal is local production, you may also need a separate manufacturing license (MD-5/MD-9 via State/CDSCO), but the import license is the entry point for bringing goods in.

Why Foreign Manufacturers Need This License

  • All notified/regulated medical devices (most Class A sterile/measuring, B, C, D) require it.
  • Non-sterile/non-measuring Class A devices are exempt from full import license but need registration (MD-42).
  • Recent 2025 circulars simplified “subsequent importer” options for multiple agents per brand, reducing redundancy for established devices.

Step-by-Step Guide for Foreign Manufacturers (2026)

  1. Classify Your Device Use CDSCO risk classification guidelines (A–D). Confirm if regulated via the portal or notifications. This determines fees, scrutiny level, and documentation depth.
  2. Appoint an Indian Authorized Agent
    • Must be an Indian entity (firm/individual) with:
      • Wholesale license (Form 20B/21B under Drugs Rules) or
      • Medical Device Registration Certificate (Form MD-42 under MDR 2017).
    • Grant a notarized/apostilled Power of Attorney (authenticated in India, by Indian Embassy in origin country, or equivalent authority).
    • The agent acts as liaison, submits applications, handles queries, and holds the MD-15 license.
  3. Register on SUGAM Portal Agent registers/activates account on SUGAM (cdscomdonline.gov.in). Foreign manufacturer provides necessary details/data.
  4. Prepare & Submit Application
    • File Form MD-14 (application for import license) online.
    • For new/novel devices (no predicate): Apply for permission first via MD-26 (leading to MD-27).
    • Upload all required documents + pay fees.
    • For brand endorsement/subsequent importer (if device already licensed via another agent): Use simplified process with existing license details.
  5. CDSCO Review & Queries CDSCO evaluates (document review, possible queries, site inspection for high-risk Class C/D). May accept international inspections (FDA, EU, etc.) or conduct own.
  6. Approval & Issuance
    • Receive Form MD-15 digitally via email/portal upon approval.
    • Validity: Perpetual (as per recent amendments), but pay retention fee every 5 years to maintain.
    • Timeline: 6–9 months typical (faster for complete/low-risk apps; longer with queries).

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

Fees per Second Schedule MDR 2017 (subject to updates):

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

Additional: Processing fees, retention every 5 years. Pay via challan on SUGAM.

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

From CDSCO official checklists:

  • Covering letter.
  • Duly filled Form MD-14.
  • Fee challan/receipt.
  • Power of Attorney + undertaking from agent (Part I, Fourth Schedule MDR 2017; authenticated/apostilled).
  • Copy of agent’s wholesale/manufacturing license or MD-42 certificate.
  • Constitution details of agent.
  • Free Sale Certificate (FSC) / Marketing Authorization from country of origin (notarized; preferably from USA, UK, EU, Canada, Japan, Australia).
  • Overseas manufacturing site registration/inspection report (last 3 years if available).
  • 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, stability data, etc.).
  • Labeling/IFU samples.
  • For subsequent importers/brand endorsement: Existing license details + no-change undertaking.

Pro Tips for Success

  • Use a reputable regulatory consultant or Authorized Agent experienced in CDSCO submissions to avoid delays.
  • Ensure all foreign documents are apostilled/notarized.
  • For manufacturing in India post-import: Comply with local GMP/ISO 13485; apply separately for manufacturing license if needed.
  • Check latest on cdsco.gov.in or SUGAM for 2026 drafts (e.g., IVD import guidance Jan 2026).
  • Recent simplifications for subsequent importers can speed entry if your device is already approved via another agent.

This route opens India’s booming medtech market—valued for its growth and “Make in India” incentives. Start with agent appointment and classification for smooth progress.

By Sam Michael

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FAQ Schema

Question: Can foreign manufacturers apply directly for CDSCO import license? Answer: No—must appoint an Indian Authorized Agent with wholesale/manufacturing license (Form 20B/21B or MD-42) to submit via Power of Attorney.

Question: What form is used to apply for the import license? Answer: Form MD-14 (application); approved as Form MD-15 (license). For new devices, MD-26/MD-27 may apply first.

Question: What are the typical fees for CDSCO import license? Answer: Vary 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, provided retention fees are paid every 5 years.

Review Schema

Item Reviewed: CDSCO Import License Process for Foreign Manufacturers in India 2026 Reviewer: Sam Michael Review Rating: 4.7/5 Review Body: Detailed, up-to-date guide on appointing agents, Form MD-14/MD-15, fees, and documents—crucial for foreign manufacturers entering India’s market. Recent updates like perpetual validity and subsequent importer options make it more accessible; always verify on official portal.

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