Medical Device License for Nephrology and Renal Care Devices
Nephrology and renal care devices are specialized medical instruments designed to diagnose, treat, and manage kidney diseases and renal conditions. These devices include dialysis machines, kidney function monitors, and therapeutic equipment that are vital for patients with kidney disorders.
The Central Drugs Standard Control Organization (CDSCO) regulates all nephrology and renal care devices under the Medical Device Rules, 2017. Whether you manufacture or import, obtaining the correct CDSCO license is mandatory for legal market access, patient safety, and product credibility.
With over 25 years of experience and 500+ successful licenses, our team guides you through every regulatory step—ensuring your nephrology devices meet the highest standards of safety, quality, and compliance.

Key CDSCO Licenses for Nephrology and Renal Care Devices

MD5 Manufacturing License
- Test License (MD13)
- Product Testing
- Documentation
- Audit by Notified Body

MD9 Manufacturing License
- Test License (MD13)
- Product Testing
- Documentation
- CDSCO Audit

MD15 Import License
- Dossier Preparation
- Foreign Certificates
- Application Submission
- CDSCO Review
All Articles on Nephrology and Renal Care Devices
CDSCO License for Hollow-fibre haemodialysis dialyser
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Hollow-fibre haemodialysis dialysers, detailing timelines, costs, documents, and practical tips.
CDSCO License for Peritoneal dialysis catheter adaptor
Expert guidance on obtaining CDSCO MD5 manufacturing license for Peritoneal Dialysis Catheter Adaptors, covering timelines, costs, documents, and practical steps.
CDSCO License for Dialyser connector
Expert guide to obtaining CDSCO MD5 license for Dialyser Connector (Class B) with detailed timelines, costs, document checklist, and practical tips from 25+ years' regulatory experience.
CDSCO License for Crimp for plier, Haemodialysis
Expert guidance on obtaining CDSCO MD5 license for Class A Crimp for Plier, Haemodialysis device with detailed timelines, costs, and document requirements.
CDSCO License for Kidney donor-organ preservation/transport system
Expert CDSCO licensing guidance for Kidney Donor-Organ Preservation Systems, detailing risk class C requirements, timelines, costs, and step-by-step regulatory compliance for Indian market entry.
CDSCO License for Shunt thrombus suction set
Expert guidance on obtaining CDSCO MD5 license for Shunt Thrombus Suction Set, including timelines, costs, documents, and practical steps for Class B nephrology devices.
CDSCO License for Dialysis apheresis unit, Therapeutic
Secure your CDSCO MD9 license for Dialysis Apheresis Units with expert guidance on timelines, documents, costs, and compliance for Class C nephrology devices.
CDSCO License for Haemodialysis dialysate water chlorine test kit/strip
Comprehensive guide to obtaining CDSCO MD5 license for Haemodialysis dialysate water chlorine test kits, covering timelines, costs, documents, and expert tips for Class B devices.
CDSCO License for Portable continuous peritoneal perfusate thermal conditioner
Navigate CDSCO licensing for Portable Continuous Peritoneal Perfusate Thermal Conditioner (Class B) with expert timelines, costs, and document guidance for seamless market entry.
CDSCO License for Hemodiafiltration system
Expert guidance on obtaining CDSCO MD9 license for Hemodiafiltration systems, covering timelines, costs, document requirements, and practical tips for Class C nephrology devices.
CDSCO License for Haemodialysis system plasma filtration unit
Navigate the CDSCO license process for your Class C Haemodialysis System Plasma Filtration Unit with expert guidance on timelines, costs, and documentation.
CDSCO License for Reverse Osmosis Unit (for dialysis)
Navigate the CDSCO licensing process for Reverse Osmosis Units (Class C) with expert guidance on timelines, costs, documentation, and regulatory compliance.
CDSCO License for Extracorporeal circuit waste bag
Expert guide for obtaining CDSCO MD5 license for Extracorporeal Circuit Waste Bags with detailed timelines, costs, and documentation for Class B nephrology devices.
CDSCO License for Sodium carbonate haemodialysis system cleaning cartridge
Expert guidance on obtaining a CDSCO MD9 manufacturing license for Sodium Carbonate Haemodialysis System Cleaning Cartridges (Class C), including timelines, costs, and document requirements.
CDSCO License for Peritoneal dialysis ultraviolet irradiation unit
Expert guide to obtaining CDSCO MD5 license for Peritoneal Dialysis UV Irradiation Unit, covering timelines, costs, documentation, and practical tips for Class B devices in nephrology.
CDSCO License for Haemodialysis system air/foam detector
Navigate the CDSCO MD9 manufacturing and import license process for your Class C haemodialysis system air/foam detector with expert timelines, documents, and cost guidance.
CDSCO License for Urinary stone retrieval basket
Expert guidance on obtaining CDSCO MD5 manufacturing license for urinary stone retrieval baskets, detailing timelines, costs, documentation, and practical steps.
CDSCO License for Hemodialysis Catheter
Expert guidance on obtaining a CDSCO MD5 manufacturing license for Hemodialysis Catheters (Class B) including timelines, costs, required documents, and practical tips.
CDSCO License for Haemodialysis conductivity standard solution
Expert guidance on obtaining CDSCO MD9 license for Haemodialysis conductivity standard solution—complete process, timelines, costs, and documentation for Class C medical devices in India.
CDSCO License for Hemodialysis system bicarbonate mixer
Navigate CDSCO licensing for your Class C Hemodialysis System Bicarbonate Mixer with expert guidance on timelines, costs, and documentation for a smooth approval process.
CDSCO License for Haemodialysis Concentrate
Expert guidance on obtaining CDSCO MD9 license for Haemodialysis Concentrate, covering timelines, costs, documents, and practical tips for Class C nephrology devices.
CDSCO License for Automated peritoneal dialysis system
Expert guidance on obtaining CDSCO MD9 manufacturing and import licenses for Automated Peritoneal Dialysis Systems, with detailed timelines, costs, and documentation tailored for Class C devices.
CDSCO License for Hemodialysis blood tubing/Extracorporeal systems for blood purification
Expert guide to obtaining CDSCO MD5 license for Hemodialysis Blood Tubing, covering timelines, costs, detailed document requirements, and practical tips for smooth approval.
CDSCO License for Electrical conductivity measuring instrument for dialysis fluid
Expert guidance on obtaining CDSCO MD9 license for electrical conductivity measuring instruments for dialysis fluid, covering timelines, costs, documents, and practical tips for Class C nephrology devices.
CDSCO License for Kidney stone filter
Get expert guidance on obtaining the CDSCO MD9 manufacturing license for your Class C Kidney Stone Filter, including timelines, costs, and detailed documentation requirements.
CDSCO License for Multi-patient dialysis fluid delivery system
Expert guidance on obtaining CDSCO MD9 license for Multi-patient dialysis fluid delivery systems, covering timelines, costs, documents, and practical steps for smooth regulatory approval in India.
CDSCO License for Peritoneal Dialysis Transfer Set
Expert guidance on obtaining CDSCO MD5 license for Peritoneal Dialysis Transfer Sets, including timelines, costs, documentation, and practical tips for Class B nephrology devices.
CDSCO License for Disposable Hemoperfusion Cartridge
Expert guidance on securing CDSCO MD9 license for Disposable Hemoperfusion Cartridge (Class C), including timelines, costs, documentation, and practical tips from 25+ years’ experience.
CDSCO License for Haemodialysis system central monitor
Expert guidance on obtaining CDSCO MD9 license for Haemodialysis System Central Monitor (Class C), covering timelines, documents, costs, and practical steps for seamless regulatory approval.
CDSCO License for Peritoneal dialysis dialysate warmer
Navigate CDSCO licensing for Peritoneal Dialysis Dialysate Warmers (Class C) with expert guidance on timelines, costs, documents, and practical steps for smooth approval.
CDSCO License for Peritoneal dialysis catheter guidewire
Expert guidance on obtaining CDSCO MD5 license for Peritoneal Dialysis Catheter Guidewire (Class B), detailing timelines, costs, documents, and practical tips for smooth approval.
CDSCO License for Haemodialyzer reprocessing system
Expert guidance on obtaining CDSCO MD9 license for Haemodialyzer reprocessing systems (Class C) including timelines, costs, documentation, and practical tips for seamless market entry.
CDSCO License for Peritoneal dialysis system dialysate filter
Expert guidance on securing CDSCO MD9 manufacturing license for Class C Peritoneal Dialysis System Dialysate Filters with timelines, costs, and practical tips.
CDSCO License for Citric acid haemodialysis system cleaning cartridge
Expert guidance on obtaining CDSCO MD5 license for Citric Acid Haemodialysis System Cleaning Cartridge, including timelines, costs, document checklist, and regulatory insights for Class B nephrology devices.
CDSCO License for Collagen-containing peritoneum absorbable catheter cuff
Expert guidance on obtaining CDSCO MD9 license for Class D collagen-containing peritoneum absorbable catheter cuffs, including timelines, costs, and document requirements.
CDSCO License for Haemofilters
Expert guide to obtaining CDSCO MD9 license for Class C haemofilters, with detailed timelines, costs, and document requirements for smooth market entry in India.
CDSCO License for Absorbable peritoneum catheter cuff
Navigate CDSCO MD9 license approval for your Class D Absorbable Peritoneum Catheter Cuff with our expert 25+ years guidance on timelines, costs, and documentation.
CDSCO License for Chair, Haemodialysis, Electrically powered/Manual.
Expert guidance on obtaining CDSCO MD5 license for Chair, Haemodialysis (Class A) with timelines, costs, and document insights to streamline your Indian market entry.