We assist foreign manufacturers and Indian authorized agents in obtaining MD-14 Import License under Medical Device Rules 2017. Our Regulatory experts handle documentation, SUGAM portal submission, and CDSCO query management for smooth and timely apporval.

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Our Lab Certification

Our Main Service

India market Entry for US Medical Device Manufacturers

Our Facilities

  • Indian Authorized Agent Services
  • Fast Documentation Review
  • Transparent Process & Timeline 

Service US & Global Manufacturers

Remote regulatory support for: 

  • United State
  • Europe
  • Asia-Pacific 

Schedule Free Consultation

Planning to export medical devices to India? 

Our team handles CDSCO registration, MD-14 filling, documentation review, and regulatory query responses – ensuring smooth and compliant approval.

Book an appoitnment

+91 8920964801

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India Market entry Experts for uS medical Device companies

Regulatory Consulting | MD 14 Import Licence | Authorized Agent Representation 

Specialized in CDSCO Import License MD-14 & Indian Authorized Agent Services

“Clear regulatory guidance and structured documentation support for smooth India market entry.”

Regulatory Consulting Team

India Medical Device Compliance Experts

helping uS Medical Device manfacturers Successfully Enter the Indian Market since
2020

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cDSCO mD-14 Import License

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Indian Authorized Agent Service

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Regulatory Documentation & compliance

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why uS medical device manufacturers trust us

Entering the Indian medical device market require deep regulatory knowledge and structured documentation. We provide professional CDSCO compliance support, ensuring smooth and accurate MD-14 import license approval.

cDSCO Regulatory expertise

In depth knowledge of Medical Device Rules 2017 and import compliance requirements.

Indian Authorized Agent support

Complete representation services for foreign manufacturers entering India.

Accurate Documentation Review

Technical file verification, Form MD-14 preparation, and compliance gap analysis.

Transparent & Timely Process

Clear Communication, defined timelines, and proactive query handling.

Successful India market Entry Cases

Examples of medical device import Licensing and regulatory compliance support provided to global manufacturers entering the Indian market.

What Our Regulatory clients Say | client feedback - india market entry support

Rated 5 out of 5
"our team received structured guidance for CDSCO MD-14 filling and documentation preparation. The process was clearly explained and professionally managed."
INTERNATIONAL MEDICAL DEVICE MANUFACTURER
Rated 5 out of 5
"Reliable regulatory coordination and transparent communication throughout the India registration process."
foreign device exporter
Rated 5 out of 5
"Strong understanding of Indian Medical Device Rules and compliance requirements."
Global healthcare company

dedicated regulatory support for global manufacturers

Our regulatory advisory team specializes in CDSCO Medical Device Rules 2017, MD-14 import licensing, and Indian Authorized agent services for foreign manufacturers entering the Indian Market.

Experience with class a b & c device registrations

Head of Laboratory Department

supporting uS & global manufacturers

Senior Pathologist

transparent regulatory coordination

Laboratory Technician

enter the imdian market with full cDSCO Compliance

End to End MD-14 Import License Consultancy Under Medical Device Rules, 2017.

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Address

103, First Floor. Harsha Corner Complex, Gazipur 110096 India | 323 Nangloi Delhi 10041 near Nangloi Metro Station India

Whatsapp Now

+91-8920964801