AUTHORIZED REPRESENTATIVE SERVICES IN INDIA
Your Authorized Representative in India for Medical Devices
Enter the Indian medical device market with confidence.
Sinnov8 provides Authorized Indian Representative services to overseas medical device manufacturers, supporting regulatory submissions, CDSCO licensing, compliance management and ongoing regulatory coordination in India.
Services Offered
- Authorized Indian Representative
Act as the overseas manufacturer's authorized agent in India under the applicable regulatory framework, with support for regulatory representation and coordination with CDSCO.
- CDSCO Import Licensing
Support applications, documentation, submissions and licensing coordination for medical device imports, including MD-14 and MD-15 pathways, as applicable.
- Regulatory Compliance Management
Support ongoing compliance with the Medical Devices Rules, 2017, including licence conditions, regulatory changes and documentation updates.
- Post-Market Surveillance & Vigilance
Support adverse event reporting, safety communication, field safety corrective actions and recall-related regulatory coordination.
- Import & Market Access Support
Coordinate with importers and distributors on regulatory documentation, product registration requirements and India market-entry activities.
- Ongoing Regulatory Support
Assist with product additions, brand changes, model additions, licence amendments, renewals where applicable and regulatory queries.
Why Choose Sinnov8?
- Dedicated Indian Regulatory Partner
A single point of contact for regulatory coordination.
- Medical Device Expertise
Experience across Class A, B, C and D medical devices and IVDs.
- End-to-End RAQA Capabilities
Regulatory Affairs, Quality Assurance and market access services.
- CDSCO Licensing Experience
Support across import licensing and post-licensing activities.
- international Manufacturer Focus
Support for overseas manufacturers entering the Indian market.
- Scalable Engagement:
Flexible support depending on the manufacturer's product portfolio and regulatory requirements.
Who Should Use Our Services?
Our Authorized Representative services are designed for:
- Medical device manufacturers based in the USA
- European medical device manufacturers
- UK-based medical device manufacturers
- Manufacturers from South Korea, Japan and other international markets
- Overseas IVD manufacturers
- Medical technology startups and SMEs planning to enter India
How the Booking Process Works
1
Initial Regulatory Assessment
Define the engagement, authorization requirements and supporting documentation.
2
Appointment & Documentation
Define the engagement, authorization requirements and supporting documentation.
3
CDSCO Licensing Support
Coordinate applicable import licence applications and regulatory submissions.
4
Regulatory Representation
Provide agreed authorized-agent support and regulatory coordination.
5
Ongoing
Compliance
Ongoing Compliance
Support post-licensing activities, regulatory changes and vigilance-related obligations.
Why India Needs a Local Regulatory Representative
Planning to sell your medical devices in India?
India regulates medical devices under the Medical Devices Rules, 2017. Overseas manufacturers generally need an appropriately appointed authorized agent in India to support applicable import licensing and regulatory obligations.
Sinnov8 helps international manufacturers navigate these requirements through local regulatory representation, CDSCO licensing support and ongoing compliance assistance.
Looking for an Authorized Representative in India?
Let Sinnov8 be your local regulatory partner for medical device market entry and ongoing compliance in India.
