CDSCO Licence for ECG Machines in India: Class B Registration, IEC 60601-2-25 and Process
CDSCO registration for ecg machines in India — Class B device, Form MD-5/MD-15, IEC 60601-2-25 & IEC 60601, documents, fees and timeline.
Compliance Guides – Page 3
CDSCO Licence for Digital Thermometers in India: Class B Registration, ISO 80601-2-56 and Process
CDSCO registration for digital thermometers in India — Class B, Form MD-5/MD-15, ISO 80601-2-56, documents, fees and timeline.
CDSCO Licence for Dialysers in India: Class C Registration, ISO 8637 and Process
CDSCO registration for dialysers in India — haemodialysers, Class C device, Form MD-9/MD-15, ISO 8637 & ISO 10993, documents, fees and timeline.
CDSCO Licence for Dental Implants in India: Class C Registration, ISO 14801 and Process
CDSCO registration for dental implants in India — Class C implant, Form MD-9/MD-15, ISO 14801 fatigue & ISO 10993, documents, fees and timeline.
CDSCO Licence for Dental Chairs in India: Class B Registration, ISO 6875 and Process
CDSCO registration for dental chairs in India — dental units, Class B, Form MD-5/MD-15, ISO 6875 & IEC 60601, documents, fees and timeline.
CDSCO Licence for Defibrillators in India: Class C Registration, IEC 60601-2-4 and Process
CDSCO registration for defibrillators in India — external defibrillators & AEDs, Class C, Form MD-9/MD-15, IEC 60601-2-4, documents, fees and timeline.
CDSCO Licence for CT Scanners in India: Class C Registration, IEC 60601-2-44 and Process
CDSCO registration for ct scanners in India — Class C device, Form MD-9/MD-15, IEC 60601-2-44 & IEC 60601, plus AERB, documents, fees and timeline.
CDSCO Licence for Bone Cement in India: Class D Registration, ISO 5833 and Process
CDSCO registration for bone cement in India — PMMA Class D device, Form MD-9/MD-15, ISO 5833, required documents, government fees and the approval timeline.
CDSCO Licence for Cochlear Implants in India: Class D Registration, ISO 14708-7 and Process
CDSCO registration for cochlear implants in India — Class D route, Form MD-9/MD-15, ISO 14708-7, government fees and the approval timeline.
CDSCO Licence for Blood Tubing Sets in India: Class C Registration, ISO 8637-2 and Process
CDSCO registration for blood tubing sets in India — Class C device, Form MD-9/MD-15, ISO 8637-2, government fees and the approval timeline.