Importing medical devices into India requires compliance with the regulations established by the Central Drugs Standard Control Organization (CDSCO). Whether you are a foreign manufacturer, authorized Indian representative, importer, or distributor, obtaining the appropriate CDSCO Import License is a critical step before placing medical devices on the Indian market.
Our CDSCO import license consulting services help medical device companies navigate the complete registration and licensing process efficiently while ensuring compliance with the Medical Devices Rules, 2017.

Our CDSCO Import License Services

• Import License Application Support (MD-14 & MD-15)
• Authorized Indian Agent Assistance
• Device Classification Assessment
• Regulatory Documentation Review
• Technical File and Dossier Preparation
• Free Sale Certificate Evaluation
• ISO 13485 Documentation Support
• CDSCO Query Response Management
• Import Compliance Guidance
• Post-Approval Regulatory Support

Who Can Benefit?

• Foreign Medical Device Manufacturers
• Medical Device Importers
• Authorized Indian Representatives
• Healthcare Product Distributors
• Diagnostic Device Manufacturers
• In-Vitro Diagnostic (IVD) Companies

Why Professional CDSCO Consulting Matters

The CDSCO import licensing process involves detailed technical documentation, regulatory submissions, and compliance verification. Incomplete or inaccurate submissions can result in delays, additional queries, or application rejection. Experienced regulatory consultants help streamline the process, reduce compliance risks, and improve the chances of timely approval.

Why Choose TRACC Global?

TRACC Global provides comprehensive regulatory consulting solutions for medical device manufacturers and importers seeking market access in India. Our team supports clients throughout the licensing lifecycle, from document preparation and application submission to regulatory correspondence and post-approval compliance.

Get Expert Assistance

Planning to import medical devices into India? Contact TRACC Global for professional guidance on CDSCO Import License applications, regulatory requirements, and compliance support.

Contact Us Today

• Regulatory Consultation
• Import License Assessment
• Documentation Review
• End-to-End CDSCO Support

Visit TRACC Global to discuss your CDSCO Medical Device Import License requirements and receive expert regulatory assistance.