CDSCO manufacturing license process 2026

The CDSCO manufacturing license process for medical devices in India is governed by the Medical Devices Rules, 2017 (with ongoing updates and amendments through 2026). The Central Drugs Standard Control Organisation (CDSCO) oversees approvals, primarily through its online SUGAM portal (cdscomdonline.gov.in). Licensing depends on the device’s risk classification (Class A to D), with State Licensing Authorities handling lower-risk devices (Class A and B) and Central Licensing Authority (CLA) managing higher-risk ones (Class C and D).

All medical devices are regulated since 2020 notifications, except non-sterile, non-measuring Class A devices (exempt from licensing per recent exemptions).

Key Forms for Manufacturing License

Forms vary by risk class:

• Class A and B (Low to Moderate Risk) — Issued by State Licensing Authority (effective for notified devices since October 2022).
  • Application Form: MD-3 (for fresh grant to manufacturer) or MD-4 (for loan license).
  • License Form: MD-5 (manufacturing license) or MD-6 (loan license).
• Class C and D (Moderate-High to High Risk) — Issued by Central Licensing Authority (CDSCO) (effective for non-notified since October 2023).
  • Application Form: MD-7 (for fresh grant) or MD-8 (for loan license).
  • License Form: MD-9 (manufacturing license) or MD-10 (loan license).

These forms apply to manufacturing for sale/distribution. Test licenses (small quantities for evaluation/training) use separate forms like MD-16/MD-17.

Step-by-Step Procedure to Obtain Manufacturing License

1. Classify the Device — Use CDSCO risk-based classification guidelines (based on intended use, invasiveness, etc.). Check if notified/regulated via the CDSCO portal or notifications.
2. Prepare Facility & Compliance — Ensure the manufacturing site complies with ISO 13485 (Quality Management System), GMP, and essential safety/performance principles. Appoint qualified technical staff.
3. Register on SUGAM Portal — Create/login to the CDSCO SUGAM portal (or NSWS portal). Upload required documents and pay fees online.
4. Submit Application — File the appropriate form (MD-3/MD-7) with supporting files:
   • Covering letter
   • Fee challan/receipt
   • Site Master File (SMF) / Plant Master File (PMF) as per Fourth Schedule
   • Device Master File (DMF) with technical details
   • ISO 13485 certificate
   • Layout plan, machinery list, qualified personnel details
   • Constitution of firm documents
   • Risk analysis, stability data, labeling, etc. (per checklist on portal)
5. Pay Fees — Vary by class (approximate, in INR; check portal for exact/current rates):
   • Class A/B: License fee ~₹5,000 + ₹500 per device.
   • Class C/D: License fee ~₹50,000 + ₹1,000 per device (higher for complex/high-risk).
   • Additional fees for variations/endorsements.
6. Review & Inspection — CDSCO/State authority reviews documents. May raise queries or schedule site inspection (mandatory for most cases).
7. Approval & Issuance — If compliant, license issued digitally (MD-5/MD-9) via email/portal. Rejection includes reasons.

Timeline: Typically 4–9 months (4–6 for Class A/B; longer for C/D due to detailed scrutiny/inspection). Delays possible from queries or incomplete docs.

Validity: Perpetual (as per amendments), subject to paying license retention fee every 5 years to maintain.

Post-Approval: Comply with post-market surveillance, adverse event reporting, and audits. For loan licenses (third-party manufacturing), additional rules apply.

Always verify latest checklists, fees, and notifications on the official CDSCO website (cdsco.gov.in) or SUGAM portal, as regulations evolve (e.g., 2025–2026 updates on perpetual validity, simplified processes, and exemptions). Consult a regulatory expert or authorized consultant for complex applications.

Comparison Table: Manufacturing License by Risk Class

Risk Class	Licensing Authority	Application Form	License Form	Typical Timeline	Key Focus Areas	Fee Example (Approx.)
Class A & B (Low-Moderate)	State Licensing Authority	MD-3 (fresh) / MD-4 (loan)	MD-5 / MD-6	4–6 months	Site compliance, basic QMS	₹5,000 license + ₹500/device
Class C & D (Moderate-High to High)	Central Licensing Authority (CDSCO)	MD-7 (fresh) / MD-8 (loan)	MD-9 / MD-10	6–9+ months	Detailed technical review, inspection	₹50,000 license + ₹1,000/device

This process ensures devices meet safety, quality, and efficacy standards before market entry in India.

By Sam Michael

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FAQ Schema

Question: What forms are used for CDSCO manufacturing license for Class A and B devices? Answer: Application in Form MD-3 (or MD-4 for loan license), with license issued in Form MD-5 (or MD-6).

Question: Who issues the manufacturing license for Class C and D medical devices? Answer: The Central Licensing Authority (CDSCO) issues it via Form MD-9 (or MD-10 for loan license) after application in Form MD-7/MD-8.

Question: How long is a CDSCO manufacturing license valid? Answer: Perpetual, but requires payment of retention fees every 5 years.

Question: What is the typical timeline for obtaining a CDSCO manufacturing license? Answer: 4–9 months, depending on risk class, documentation completeness, and inspection requirements.

Review Schema

Item Reviewed: CDSCO Medical Device Manufacturing License Process Reviewer: Sam Michael Review Rating: 4.6/5 Review Body: The process under Medical Devices Rules 2017 is structured and online-focused via SUGAM—forms like MD-3/MD-5 for lower risk and MD-7/MD-9 for higher ensure compliance, though timelines can stretch with inspections. Essential for market entry in India’s growing medtech sector.