A Complete Guide to Import of Medical Devices in India under Medical Devices Rules, 2017 (As Amended up to 2025)

The import of medical devices in India is governed by Chapter V of the Medical Devices Rules, 2017 (as amended). With the introduction of perpetual licensing (valid forever, subject to retention fee every 5 years), the process has become more business-friendly, yet remains stringent to ensure patient safety. Below is a practical, step-by-step guide for importers, authorised agents, and overseas manufacturers.

1. Who Can Apply for an Import Licence?

Only an Indian Authorised Agent who already holds:

• A valid Wholesale Licence (Form MD-42/MD-44) OR
• A Manufacturing Licence (for sale/distribution)

can apply for an Import Licence in Form MD-15.

2. Application Process (Rule 34)

3. Fast-Track Route for GHTF Countries (Rule 36(3))

If your device has a Free Sale Certificate (FSC)/Certificate to Foreign Government (CFG) from any of these five regulatory jurisdictions:

• Australia (TGA)
• Canada (Health Canada)
• Japan (MHLW/PMDA)
• European Union (Notified Body CE certificate under MDR/IVDR)
• United States (US FDA 510(k) clearance or PMA)

→ No clinical investigation in India is required even for Class C & D devices.

Licence is normally granted within 9 months (often much faster now).

4. Devices from Non-GHTF Countries (Rule 36)

Class A & B: Published safety/performance data + FSC from country of origin is sufficient.

Class C & D: Generally require local clinical investigation in India unless waived on a case-to-case basis.

6. Validity of Import Licence (Rule 37) – Perpetual Licence

• Valid in perpetuity (forever)
• Pay Licence Retention Fee after every 5 years (per manufacturing site & per device)
• Late fee: 2% per month (max 90 days)
• Failure to pay within 90 days → Licence deemed cancelled

7. Major Post-Approval Responsibilities of the Authorised Agent (Rule 38)

8. Change in Constitution (Rule 39)

If the overseas manufacturer or authorised agent changes constitution (merger, acquisition, etc.), apply afresh within 180 days. Existing licence remains valid till new one is issued/rejected.

9. Test Licence for Clinical Investigation, Demo & Training (Rule 40–41)

• Apply in Form MD-16 → Granted in Form MD-17 (valid 3 years)
• Strictly for test, evaluation, CI, demo, training only
• Quantity decided by CDSCO
• Record keeping mandatory

10. Compassionate Use / Unmet Medical Need (Rule 42)

Government hospitals can apply in Form MD-18 for life-threatening conditions → Permission in Form MD-19

11. Personal Use Import (Rule 43)

• As part of bona-fide personal baggage (with prescription) – no prior permission
• Courier/post (not baggage) → Apply in Form MD-20 → Permission in Form MD-21 (decided in 7 days)

Quick Reference Table: Key Forms for Import

PRO TIPS FOR SMOOTH APPROVALS

1. Always appoint an experienced Indian Authorised Agent with wholesale licence.
2. For GHTF-country devices, approval is almost routine if documents are complete.
3. Start paying retention fee well before the 5-year mark – avoid late fees.
4. Keep Sixth Schedule handy – many changes are now “deemed approved” after 60 days of silence.
5. Report any global regulatory action within 15 days – delay can lead to suspension.

The perpetual licensing system introduced in 2020 and retained in all subsequent amendments has drastically reduced renewal burden, making India one of the most attractive markets for medical device companies worldwide.

For latest fees (Second Schedule) and document checklist (Fourth & Sixth Schedules), always refer to the official CDSCO website or the latest Gazette notification.

Stay compliant, stay safe!

Last Updated : 13 Feb 2026