How to start
- Get an Import Export Code (IEC) from DGFT online; it is free and linked to your PAN.
- Register with EPCMD and get your RCMC (Registration-cum-Membership Certificate) through the DGFT e-RCMC system.
- Low-risk devices (dressings, bandages, simple instruments) need simpler approvals; start there.
- Many African and Asian markets accept Indian licence plus ISO 13485 with local registration.
Top buyer countries
- United States315.65 US$ million · 2025-26
- Germany108.32 US$ million · 2025-26
- Netherlands85.78 US$ million · 2025-26
- Brazil71.29 US$ million · 2025-26
- China53.1 US$ million · 2025-26
Certificates and registrations
- CDSCO manufacturing licence under the Medical Devices Rules, 2017
- ISO 13485 quality system
- CE marking under EU MDR, US FDA 510(k) or listing, or registration in the importing country
Watch out for
- EU MDR certification is slow and costly for small firms.
- The Principal Commodity group covers medical and scientific instruments together.
Businesses in the encyclopedia
Disposable Plastic Syringes →Surgical Bandage Making Unit →Surgical Absorbent Cotton (Cotton Wool) →Surgical Adhesive Tape Unit →
Sources (3)
- TradeStat, Department of Commerce — Export: Principal Commodity-wise, April–March 2026 (provisional), US$ million — row "M8, MEDICAL AND SCIENTIFIC INSTRUM"
- TradeStat (Export Import Data Bank), Department of Commerce — Commodity-wise all countries export, HS 9018, 2025-26, US$ million · 2025-26
- HBP Appendix 2T — List of EPCs / Commodity Boards (DGFT), via research/export-import.json · 2023
