Government Authority
Ministry of Health & Family Welfare, Government of India
CDSCO Regulatory Consultancy Services
Professional Medical Device Regulatory Support for the Indian Market
Complete licensing, registration, documentation, and regulatory compliance services for medical device manufacturers and importers in India.
About CDSCO
CDSCO (Central Drugs Standard Control Organization) is India's national regulatory authority for pharmaceuticals, cosmetics, and medical devices operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
The organization is responsible for ensuring the safety, quality, performance, and regulatory compliance of medical devices marketed in India.
QM Service Global provides comprehensive CDSCO consultancy services to manufacturers, importers, and healthcare organizations seeking regulatory approvals for medical devices.
Our CDSCO Regulatory Services
Professional regulatory support for Class A, B, C & D Medical Devices.
CDSCO Manufacturing License
Class A & B Devices
• FORM MD-3 Application
• FORM MD-5 Manufacturing License
Class C & D Devices
• FORM MD-7 Application
• FORM MD-9 Manufacturing License
Complete documentation, quality management system review, regulatory submissions, and licensing support.
CDSCO Import License
All Classes of Medical Devices
• FORM MD-14 Application
• FORM MD-15 Import License
Regulatory support for foreign manufacturers seeking market access in India including technical documentation and regulatory submissions.
CDSCO Test License
For All Classes of Medical Devices
• FORM MD-11 Application
• FORM MD-12 Test License
Support for clinical investigation, performance evaluation, product testing, and regulatory approvals.
CDSCO Manufacturing Loan License
Class A & B Devices
• FORM MD-4 Application
• FORM MD-6 Loan License
Class C & D Devices
• FORM MD-8 Application
• FORM MD-10 Loan License
Complete consultancy support for third-party manufacturing arrangements and licensing approvals.
Why Choose QM Service Global?
Expert Documentation
Professional preparation of regulatory dossiers and application packages.
Regulatory Guidance
End-to-end support throughout the approval process.
Faster Approvals
Structured submission process to minimize delays.
Complete Compliance
Support aligned with current CDSCO Medical Device Rules.
Our Consultancy Support Includes
✔ Device Classification Assistance
✔ Regulatory Strategy Development
✔ Technical Documentation Preparation
✔ Application Submission Support
✔ Quality Management System Compliance
✔ Authority Liaison Support
✔ Audit & Inspection Preparation
✔ Post-Approval Regulatory Guidance
Ready to Obtain CDSCO Approval?
Partner with QM Service Global for professional CDSCO licensing, registration, and regulatory consultancy services.