MD-09 License for Class C & D Devices
Moderate-high risk (Class C) and high-risk (Class D) medical devices (such as implants, active diagnostics, and cardiac devices) require a Form MD-09 manufacturing license. This license is issued directly by the Central Licensing Authority (CDSCO Headquarters, New Delhi). The approval process is highly technical, demanding rigorous product evaluation, clinical data validation, and a joint inspection by Central and State drug inspectors. We provide comprehensive dossier preparation, clinical data writing, and regulatory liaison.
Key Benefits
- Rigorous pre-screening of technical files by senior regulatory consultants
- Liaison with Central Licensing Authority (CLA) and joint inspection teams
- Accelerated resolution of CDSCO technical and clinical validation queries
Recognized Standards
Our Methodology
Required Documents
Common Questions
Related Regulatory Insights
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