Class C & D Manufacturing
(Forms MD-7 & MD-9)
Navigate stringent CDSCO regulations to secure your MD-9 license for manufacturing high-risk and moderate-risk medical devices in India.
Consult Our CDSCO Experts
High & Moderate Risk Devices
Companies established in India intending to manufacture and distribute high-risk or moderate-high risk medical devices must obtain a manufacturing license from the Central Licensing Authority (CLA).
Class C: Moderate-High Risk
Requires strict regulatory controls compared to lower classes.
- Blood Bags
- Catheters
- Disposable Perfusion Sets
- Ablation Devices
Class D: High Risk
Subject to the most stringent regulations to ensure patient safety.
- Aneurysm clips
- Heart Valves
- Cortical electrodes
- Cervical spine immobilization
The MD-7 to MD-9 Process
Form MD-7 is the application submitted electronically via the CDSCO portal. Upon successful review, the CLA grants Form MD-9, the official manufacturing license.
Application via MD-7
Electronic submission to the Central Licensing Authority.
Rigorous Documentation
Submit Plant & Device Master Files (MDR 2017 format), robust QMS documentation, valid Quality Certificates, Test Licenses, and IVD performance evaluation reports if applicable.
CDSCO Audit & Inspection
The CLA will review the dossier and conduct a thorough physical inspection of the manufacturing site to verify Fifth Schedule QMS compliance.
MD-9 Issuance
The license is granted indefinitely, contingent on the payment of retention fees every 5 years to avoid suspension.
Expert Regulatory Guidance
Due to the critical risk associated with Class C & D devices, CDSCO scrutiny is intense. We ensure your facility and dossiers are perfectly compliant.
- Site readiness & mock audits for licensing
- MDR 2017 compliant Device/Site Master Files
- ISO 13485 QMS implementation support