MD-10 Loan License for Class C & D Devices
An MD-10 Loan License allows companies to manufacture Class C and D devices (implants, active devices) at contract facilities that hold valid MD-09 manufacturing licenses. This is issued by the Central Licensing Authority (CLA) in New Delhi and requires comprehensive dossier compliance and tech-transfer documentation. We assist in tech-transfer protocols, stability studies, and SUGAM filings.
Key Benefits
- Enables rapid production scale-up of complex devices
- Reduces cleanroom construction costs
- Fully CDSCO compliant contract manufacturing
Recognized Standards
Our Methodology
Required Documents
Common Questions
Related Regulatory Insights
Navigating the New CDSCO Medical Device Regulations: A Definitive Compliance Guide
Understand the regulatory shift under India's Medical Device Rules (MDR) 2017, classification pathways, and MD-15 import licensing requirements for global manufacturers.
The MD-42 Trade License: Selling Medical Devices in India
A breakdown of the MD-42 wholesale registration requirements for distributors, importers, and traders operating in India.
Need Assistance with MD-10 Loan License for Class C & D Devices?
Our experts are ready to guide you through every step of the regulatory process. Let's discuss your project today.
Speak with a Consultant