Blogs & Compliance Insights
Browse our compliance blogs and certification guides for manufacturers and importers in India, covering BIS, CDSCO, BEE, WPC, EPR, DGFT and more.
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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CDSCO Licence for Blood Pressure Monitors in India: Class B Registration, IEC 80601-2-30 and Process
CDSCO registration for blood pressure monitors in India — Class B classification, IEC 80601-2-30 and ISO 81060-2 standards, documents, fees and timeline.
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