CDSCO Licence for Orthopaedic Implants in India: Class C Registration, ISO 5832 and Process
CDSCO registration for orthopaedic implants in India — screws & trauma implants, Class C, Form MD-9/MD-15, ISO 5832/14630, documents, fees and timeline.
Medical Devices – Guides & Updates
Guides to registering medical devices in India with CDSCO under the Medical Devices Rules 2017. Learn how devices are classified into risk classes A to D, when you need an import licence (MD-14/MD-15) or a manufacturing licence, the documents and quality certificates required, and typical timelines. Each guide focuses on a specific device type. For regulatory support, see our CDSCO medical device registration service.
CDSCO Licence for Nebulizers in India: Class B Registration, ISO 27427 and Process
CDSCO registration for nebulizers in India — Class B device, Form MD-5/MD-15, ISO 27427 & IEC 60601, documents, fees and timeline for makers and importers.
CDSCO Licence for Surgical Gloves in India: Class B Registration, IS 4148 and Process
CDSCO registration for surgical gloves in India — Class B device, Form MD-5/MD-15, IS 4148 & ISO 10282, sterilisation, documents, fees and timeline.
CDSCO Licence for Surgical Blades & Scalpels in India: Class A Registration, ISO 7740 and Process
CDSCO registration for surgical blades & scalpels in India — Class A device, Form MD-5/MD-15, ISO 7740, sterility, documents, fees and timeline.
CDSCO Licence for Suction Machines in India: Class B Registration, ISO 10079 and Process
CDSCO registration for suction machines in India — medical aspirators, Class B, Form MD-5/MD-15, ISO 10079 & IEC 60601, documents, fees and timeline.
CDSCO Licence for Spinal Implants in India: Class D Registration, Standards and Process
CDSCO registration for spinal implants in India — Class D implant, Form MD-9/MD-15, ISO 5832/14630, documents, fees and timeline.
CDSCO Licence for Pulse Oximeters in India: Class B Registration, ISO 80601-2-61 and Process
CDSCO registration for pulse oximeters in India — Class B device, Form MD-5/MD-15, ISO 80601-2-61 & IEC 60601, accuracy, documents, fees and timeline.
CDSCO Licence for Hospital Beds in India: Class B Registration, IEC 60601-2-52 and Process
CDSCO registration for hospital beds in India — electric medical beds, Class B, Form MD-5/MD-15, IEC 60601-2-52, documents, fees and timeline.
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.
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.