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