Medical Device Import License in India — Form MD-14 / MD-15 Guidance
Form MD-14 is the official application submitted to CDSCO’s Central Licensing Authority for an import license for medical devices. Form MD-15 is the legal import license issued upon approval — the statutory document authorizing foreign-manufactured medical devices to be imported, cleared through customs, and sold across India. Every Class A, B, C, and D medical device manufactured overseas requires a valid MD-15 license before arriving at Indian ports. DK Reg Compliance prepares Device Master Files, acts as or supports Indian Authorised Agents, and drives SUGAM portal approvals.
- Foreign medical device manufacturers entering India across Class A, B, C, and D risk categories
- Indian medical equipment distributors and importers acting as authorized national distributors
- Indian Authorised Agents (IAA) filing multi-product import dossiers on behalf of overseas principals
Connect with our senior regulatory experts in 15 mins.
Overview & Local Scope
Fast-Track Medical Device Import License India | MD-14 & MD-15 Consultant in Karnataka
Form MD-14 is the official application submitted to CDSCO’s Central Licensing Authority for an import license for medical devices. Form MD-15 is the legal import license issued upon approval — the statutory document authorizing foreign-manufactured medical devices to be imported, cleared through customs, and sold across India. Every Class A, B, C, and D medical device manufactured overseas requires a valid MD-15 license before arriving at Indian ports. DK Reg Compliance prepares Device Master Files, acts as or supports Indian Authorised Agents, and drives SUGAM portal approvals.
Need help with Medical Device Import License India | MD-14 & MD-15 Consultant in Karnataka?
Our local experts are ready to guide you through the process.
Contact UsForeign medical device manufacturers entering India across Class A, B, C, and D risk categories
Indian medical equipment distributors and importers acting as authorized national distributors
Indian Authorised Agents (IAA) filing multi-product import dossiers on behalf of overseas principals
In-vitro diagnostic (IVD) kit and instrument importers seeking rapid customs clearance
Healthcare institutions importing specialized or heavy medical diagnostic machinery
Step-by-step process
How our Karnataka registration works
Indian Authorised Agent (IAA) Verification: We verify or establish your Indian Authorised Agent holding valid Form 20B/21B or MD-42 wholesale licenses.
Power of Attorney (POA) Execution: We draft the legal Power of Attorney in CDSCO statutory format linking the foreign site to the IAA.
Technical Dossier Compilation (MD-14): We assemble Device Master Files (DMF), Plant Master Files (PMF), CE/FDA certificates, and Free Sale Certificates.
SUGAM Portal Upload & Fee Payment: We submit Form MD-14 online and pay the government application fee per manufacturing site and device product.
Query Management & MD-15 Grant: We resolve technical query letters raised by CDSCO biomedical reviewers until Form MD-15 import license certificate issuance.
Documents required
Filing checklist for Karnataka
- Power of Attorney (POA) executed by the foreign manufacturer and notarized/apostilled in country of origin
- Free Sale Certificate (FSC) / Certificate to Foreign Government from country of origin health authority
- ISO 13485:2016 Quality Management System certificate of the actual overseas manufacturing site
- Device Master File (DMF) detailing device description, sterilization, biocompatibility, and clinical safety
- Plant Master File (PMF) detailing manufacturing site cleanroom layout and quality controls
- CE Certificate / US FDA 510(k) summary / PMDA approval copies (where available for fast tracking)
- Indian Authorised Agent wholesale drug license copy (Form 20B/21B or Form MD-42)
Verified Support in Karnataka
Whether you are located in the business center of Karnataka or surrounding industrial corridors, our consultants manage state and zonal submissions directly.
Guaranteed Benefits
Medical Device Import License India | MD-14 & MD-15 Consultant in Nearby Cities
Explore our fast-track regulatory consultancy and compliance assistance in nearby locations:
Other Compliance Services in Karnataka
Complete statutory and license solutions provided by our regulatory consultants:
FAQs about Medical Device Import License India | MD-14 & MD-15 Consultant in Karnataka
Find your question below or submit your inquiry for quick assistance.
Ready to proceed?