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.
Import Compliance – Guides & Updates
Guides to the approvals needed before goods can clear Indian customs. Depending on the product, importers may need an Import Export Code (IEC) from DGFT, BIS ISI or CRS certification, CDSCO registration, WPC-ETA approval, Legal Metrology (LMPC) registration or an EPR licence. These articles explain which approvals apply, in what order, and how to avoid shipments being held at port. For licensing help, see our DGFT and import services.
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.