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
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Overview & Local Scope
Fast-Track Medical Device Import License India | MD-14 & MD-15 Consultant in Ahmedabad
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.
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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 Ahmedabad 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 Ahmedabad
- 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)
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Whether you are located in the business center of Ahmedabad or surrounding industrial corridors, our consultants manage state and zonal submissions directly.
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