CDSCO – Page 4

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 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 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 registration for cochlear implants in India — Class D route, Form MD-9/MD-15, ISO 14708-7, government fees and the approval timeline.

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.

CDSCO registration for blood pressure monitors in India — Class B classification, IEC 80601-2-30 and ISO 81060-2 standards, documents, fees and timeline.

CDSCO registration for blood gas analysers in India — Class C IVD, Form MD-9/MD-15, required documents, fees and the approval timeline.

CDSCO registration for blood collection tubes in India — vacutainers, Class A device, Form MD-5/MD-15, ISO 6710, documents, fees and timeline.

Doctors thread a cardiac catheter through the blood vessels into the heart. They use it to diagnose or treat heart disease, for example in angiography, angioplasty and electrophysiology. Because it enters the central circulatory system, CDSCO regulates it as a Class C device. However, specialised ablation and structural-heart catheters can sit at the higher end.

A condom is a barrier contraceptive that also prevents the transmission of infection, so its integrity is a genuine public-health matter. CDSCO regulates the male latex condom as a Class B medical device with a defined burst-volume, leakage and freedom-from-holes test regime and validated manufacturing behind the licence. This guide covers the full CDSCO registration