CDSCO Registration for Medical Devices
CDSCO (Central Drugs Standard Control Organisation) is the national regulatory authority for pharmaceuticals and medical devices in India. All medical devices must be registered/licensed with CDSCO before they can be manufactured, imported, or sold in India under the Medical Device Rules 2017.
Medical Device Classification
- Class A: Low risk (thermometers, bandages)
- Class B: Low-moderate risk (needles, surgical gloves)
- Class C: Moderate-high risk (ventilators, implants)
- Class D: High risk (heart valves, pacemakers)
Services We Offer
- Import License (MD-14/MD-15)
- Manufacturing License (MD-3/MD-5)
- Registration for Class A & B devices
- Import/manufacturing approval for Class C & D
- Clinical investigation permission
- Free Sale Certificate (FSC)
Documents Required
- Device Master File
- ISO 13485 certificate
- CE / US FDA approval (if applicable)
- Clinical data & test reports
- Quality Management System documents
Why Choose MCS?
- Expert regulatory consultants
- Complete documentation & filing
- Faster approvals
- Post-approval compliance