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CDSCO MD-15 License for Medical Devices – Expert Consultancy by PSR Compliance Get Your Medical Device License Hassle-Free
A CDSCO MD-15 License is required for businesses dealing with Class A & B medical devices in India. At PSR Compliance, we provide end-to-end consultancy for obtaining your MD-15 license quickly and in full compliance with the Medical Device Rules, 2017 regulated by the Central Drugs Standard Control Organization (CDSCO).
Who Needs an MD-15 License?
✔ Manufacturers of Class A & B Medical Devices
✔ Importers & Distributors of Medical Devices
✔ Hospitals & Healthcare Equipment Suppliers
✔ Companies Involved in Selling Diagnostic Equipment
Examples of Class A & B Medical Devices
✅ Class A (Low-Risk Devices) – Thermometers, Surgical Dressings, Stethoscopes, Weighing Machines.
✅ Class B (Low to Moderate-Risk Devices) – Blood Pressure Monitors, Nebulizers, Syringes, Catheters.
Documents Required for MD-15 License
📌 Duly Filled MD-15 Application Form
📌 Manufacturing Site Details & Layout
📌 Product List & Device Classification (Class A/B)
📌 Quality Management System (ISO 13485 Certification)
📌 Undertaking for Compliance with Medical Device Rules, 2017
📌 Authorization Letter for CDSCO Portal Submission
Our Services
🚀 Complete MD-15 Application Filing & Approval Support
📑 Technical Documentation & Quality Compliance Assistance
🔍 ISO 13485 & Regulatory Compliance Guidance
💼 CDSCO Portal Registration & Liaison Support
⚡ Fast Processing & Hassle-Free Licensing
Why Choose PSR Compliance?
✅ Expert CDSCO Licensing Consultants
✅ 100% Compliance with Medical Device Rules
✅ Quick & Transparent Process
✅ Pan-India Support for Medical Device Businesses
📞 Apply for Your CDSCO MD-15 License Today!
📍 Available Across India | 💼 For Medical Device Manufacturers & Importers