A Simplified Guide to Manufacturing Licences for Medical Devices in India under the Medical Devices Rules, 2017

If you are planning to manufacture medical devices in India for sale or distribution, the process is now risk-based. The higher the risk class (A → B → C → D), the stricter the scrutiny. Here’s a clear, step-by-step breakdown of what Rule 20–33 actually demands.

1. Class A and Class B Medical Devices (Low to Moderate Risk)

Examples: Hypodermic syringes, surgical gloves, nebulizers, most IVD kits like pregnancy tests, glucometers, etc.

Who approves?

State Licensing Authority (SLA)

Key Highlights:

• Apply online in Form MD-3 (own manufacturing) or MD-4 (loan licence) + fees (Second Schedule).
• Submit Quality Management System (ISO 13485 equivalent) undertaking – Fifth Schedule compliance is mandatory.
• For Class A: No pre-licence audit required. Licence is granted within 45 days. Post-licence audit by Notified Body within 120 days.
• For Class B: Pre-licence audit by registered Notified Body is compulsory (audit within 90 days → report within 30 days → licence decision within 20 days).
• Licence issued in Form MD-5 (regular) or MD-6 (loan licence).
• Validity: Perpetual (forever), provided you pay retention fee every 5 years.

2. Class C and Class D Medical Devices (Moderate-High to High Risk)

Examples: Ventilators, orthopaedic implants, heart valves, stents, high-end IVDs like HIV/HCV kits, CT scanners, etc.

Who approves?

Central Licensing Authority (CDSCO)

Process:

• Apply online in Form MD-7 (own) or MD-8 (loan licence) + higher fees.
• Documents as per Part II of Fourth Schedule.
• CDSCO scrutinises documents within 45 days.
• Mandatory site inspection (within 60 days) by CDSCO officers ± experts or Notified Body.
• Inspection report → final decision within 45 days.
• Licence in Form MD-9 (regular) or MD-10 (loan licence).
• Again perpetual validity with 5-year retention fee.

3. Common Requirements for All Manufacturing Licences

• Premises must comply with Fifth Schedule (Quality Management System – largely ISO 13485).
• Competent technical staff mandatory:
  • Production in-charge: Degree + 2 yrs or Diploma + 4 yrs experience.
  • Testing in-charge: Degree/Diploma + 2 yrs in testing.
• Post-licence conditions (Rule 26) you must follow:
  • Report unexpected serious adverse events & recalls within 15 days.
  • Major changes (Sixth Schedule) need prior approval (45 days silence = deemed approval).
  • Minor changes to be informed within 30 days.
  • Batch testing & retention samples (180 days beyond expiry for invasive/IVD).
  • Maintain inspection book (Form MD-11).

4. Adding New Devices to Existing Licence

Just apply with the prescribed fee and documents to the same authority (SLA or CLA). No need for fresh full licence.

5. Test Licence for Clinical Investigation, R&D, Demonstration (Rule 31–33)

Want to make small quantities for trials or demos?

• Apply in Form MD-12 to CDSCO + fee.
• Get test licence in Form MD-13 (valid 3 years).
• Strictly for the approved purpose and premises only.

6. Validity, Retention Fee & Consequences

• All manufacturing licences are now valid forever.
• Pay licence retention fee before completion of every 5 years.
• Delay up to 180 days → pay + 2% late fee per month.

No payment within 180 days → licence deemed cancelled

7. Suspension/Cancellation & Appeal

• SLA (Class A/B) or CLA (Class C/D) can suspend/cancel after show-cause.
• Appeal within 45 days to State Government (for SLA decisions) or Central Government (for CLA decisions) → to be decided within 60 days.

8. Unannounced Inspections (Class A & B)

State authorities must conduct surprise inspections of at least 2% of the total sites audited by Notified Bodies every year.

Bottom Line – Which Path Should You Take?

Starting a medical device manufacturing unit in India has become far more structured and predictable than the old drug-licence era. Focus on building a solid QMS (Fifth Schedule) right from day one – that’s the single biggest factor that decides whether you sail through or get stuck.

Last Updated : 13 Feb 2026