CDSCO Licence for Heart Valves in India: Class D Registration, ISO 5840 and Process
CDSCO registration for heart valves in India — mechanical & tissue valves, Class D implant, Form MD-9/MD-15, ISO 5840, clinical evidence, fees and timeline.
Compliance Guides – Page 2
CDSCO Licence for HIV Test Kits in India: Class D IVD Registration and Process
CDSCO registration for HIV test kits in India — Class D IVD, Form MD-9/MD-15, performance evaluation, sensitivity/specificity, documents, fees and timeline.
CDSCO Licence for Hearing Aids in India: Class B Registration, IEC 60118 and Process
CDSCO registration for hearing aids in India — Class B device, Form MD-5/MD-15, IEC 60118 & IEC 60601, documents, fees and timeline.
CDSCO Licence for Guidewires in India: Class C Registration, ISO 11070 and Process
CDSCO registration for guidewires in India — Class C device, Form MD-9/MD-15, ISO 11070, sterility and biocompatibility, documents, fees and timeline.
CDSCO Licence for Blood Glucose Test Strips in India: Class C IVD Registration and Process
CDSCO registration for blood glucose test strips in India — Class C IVD, Form MD-9/MD-15, ISO 15197, performance evaluation, documents, fees and timeline.
CDSCO Licence for Enteral Feeding Tubes in India: Class B Registration, ISO 20695 and Process
CDSCO registration for enteral feeding tubes in India — NG/PEG tubes, Class B, Form MD-5/MD-15, ISO 20695 & ISO 80369-3, documents, fees and timeline.
CDSCO Licence for Examination Gloves in India: Class A Registration, ISO 11193 and Process
CDSCO registration for examination gloves in India — Class A device, Form MD-5/MD-15, ISO 11193 & IS 15354, documents, fees and timeline.
CDSCO Licence for Endotracheal Tubes in India: Class B Registration, ISO 5361 and Process
CDSCO registration for endotracheal tubes in India — airway devices, Class B, Form MD-5/MD-15, ISO 5361, sterility, documents, fees and timeline.
CDSCO Licence for Endoscopes in India: Class C Registration, ISO 8600 and Process
CDSCO registration for endoscopes in India — flexible & rigid, Class C, Form MD-9/MD-15, ISO 8600, reprocessing, documents, fees and timeline.
CDSCO Licence for Electrosurgical Units in India: Class C Registration, IEC 60601-2-2 and Process
CDSCO registration for electrosurgical units in India — diathermy/cautery, Class C, Form MD-9/MD-15, IEC 60601-2-2, documents, fees and timeline.