CDSCO Regulatory Services

End-to-end regulatory support for medical devices and IVDs in India.

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End-to-End Support for Indian Market Entry.

Regulatory Expertise
India Market Knowledge
End-to-End Support
Faster Time-to-Market

OVERVIEW

What Are CDSCO Regulatory Services?

We help medical device companies with classification, registration, licensing, and ongoing compliance under the Medical Devices Rules, 2017, ensuring a smooth and timely market entry in India.

OUR CDSCO SERVICES

Our CDSCO Services

Medical Device Registration
Support for device classification and registration under the Medical Devices Rules, 2017.
Import & Sale Licence Support (MD-14/15, MD-41/42)
Guidance and documentation support for import licences (Form MD-14/MD-15), sale & distribution registrations (Form MD-41/MD-42), and related submissions.
Manufacturing Licence Support
Support for manufacturing/loan licence applications (Form MD-7/MD-8) and regulatory documentation.
Post-Approval Compliance
Support for renewals, changes, and ongoing compliance with CDSCO requirements.

OUR PROCESS

A Simple and Structured Approach

01
Assess
Understand your product and regulatory requirements.
02
Plan
Define the regulatory pathway and prepare documentation.
03
Submit
Submit to CDSCO and manage queries.
04
Approve
Receive approval and ensure ongoing compliance.

KEY DELIVERABLES

Key Deliverables

Regulatory pathway and classification report
Registration and licence application documents
Technical documentation support (as per CDSCO)
Labeling and IFU compliance
Post-approval compliance support

WHY CHOOSE MEDSCAPE?

Why Choose Medscape?

India Regulatory Expertise
Experienced team with deep knowledge of CDSCO requirements.
Accurate Documentation
High-quality and compliant submissions.
Strategic Guidance
Right regulatory pathway for faster approvals.
End-to-End Support
From planning to approval and post-market compliance.