Medical Device Distribution
Healthcare Market Access & Regulatory Representation
Enabling global medical device manufacturers to access regulated healthcare markets in India through structured distribution and CDSCO regulatory support.
Regulatory Framework
CDSCO Regulatory Pathway Support
India's Central Drugs Standard Control Organisation (CDSCO) regulates the import and distribution of medical devices. We provide end-to-end regulatory support for global manufacturers entering the Indian market.
Hapto Pharmaceuticals acts as the structured distribution and regulatory representation partner for medical devices in India, navigating the complex CDSCO framework on behalf of global OEMs and manufacturers.
What We Handle
Indian Authorized Agent (IAA)
Official representation for foreign manufacturers in India
Import License (MD-14 / MD-15)
Complete import licensing for medical devices
MDRC Registration
Medical Device Registration Certificate filing
PMF / DMF Coordination
Plant Master File & Device Master File management
Post-Market Surveillance
Ongoing compliance and reporting obligations
Adverse Event Reporting
CDSCO-mandated safety reporting management
Hospital Market Penetration
Distribution network access across hospitals and clinics
Target Segments
Device Categories We Support
We work with manufacturers across a diverse range of medical device categories and are focused on enabling their seamless market entry into India.
Rehabilitation Devices
Assistive technologies and rehabilitation equipment for patient care and recovery.
Smart Wearables
Connected health devices and wearable monitoring systems for continuous patient tracking.
Class A/B/C Devices
Support across all CDSCO risk classifications — from low-risk Class A to high-risk Class C devices.
Monitoring & Diagnostic
Patient monitoring equipment and diagnostic tools for hospitals and clinical settings.
Software-Integrated Solutions
Software as a Medical Device (SaMD) and connected digital health platforms requiring regulatory clearance.
Global OEM Partnership
Full-service regulatory and distribution partnership for international medical device manufacturers.
How It Works
Market Entry Process
A structured, clear pathway from initial engagement to market presence in India.
Assessment
Device classification and regulatory pathway determination
Documentation
PMF/DMF preparation and IAA appointment
Licensing
CDSCO filing, import license (MD-14/MD-15) & MDRC
Market Entry
Distribution activation & hospital market penetration
Looking to Enter the Indian Healthcare Market?
We help global medical device manufacturers navigate CDSCO regulations, secure import licenses, and establish distribution in India.