Medical Device License for Urology Devices
Urology devices are specialized medical instruments designed to diagnose, treat, and manage conditions of the urinary system and male reproductive organs. These devices include diagnostic equipment, surgical instruments, and therapeutic devices for kidney, bladder, and prostate care.
The Central Drugs Standard Control Organization (CDSCO) regulates all urology 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 urology devices meet the highest standards of safety, quality, and compliance.

Key CDSCO Licenses for Urology 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 Urology Devices
CDSCO License for Flexible video ureteroscope, reusable
Expert CDSCO licensing guidance for Flexible Video Ureteroscope (Class B) including timelines, document requirements, costs, and practical tips for smooth approval.
CDSCO License for Inflatable penile prosthesis
Expert guide to obtaining CDSCO MD9 license for Inflatable Penile Prosthesis (Class C), detailing timelines, costs, documents, and practical steps for Indian market entry.
CDSCO License for Drip wearable urinal
Navigate CDSCO Class A licensing for your Drip wearable urinal with expert guidance on timelines, costs, documents, and regulatory compliance.
CDSCO License for Hand pneumatic lithotripsy system, urinary
Navigate CDSCO licensing for Hand Pneumatic Lithotripsy Systems (Class B) with expert guidance on timelines, costs, documents, and practical steps to ensure smooth market entry in India.
CDSCO License for Electrohydraulic lithotripsy system
Expert guidance on obtaining a CDSCO MD5 license for Electrohydraulic Lithotripsy Systems, detailing timelines, costs, documentation, and practical tips for smooth regulatory approval.
CDSCO License for Suprapubic needle, surgical, reusable
Navigate the CDSCO licensing process for your reusable suprapubic surgical needle with expert guidance on timelines, costs, and documentation for Class B medical devices in India.
CDSCO License for Flexible fibreoptic cystourethroscope
Expert guidance on CDSCO MD5 license for Flexible Fibreoptic Cystourethroscope, covering timelines, costs, documents, and practical steps for Class B urology devices in India.
CDSCO License for Hydraulic male urinary incontinence treatment system tubing
Expert guidance on obtaining your CDSCO MD9 license for Hydraulic Male Urinary Incontinence Treatment System Tubing—detailed timelines, costs, and document requirements.
CDSCO License for Rigid urethroscope
Expert guidance on obtaining CDSCO MD5 license for Rigid Urethroscope (Class B) with detailed timelines, costs, documents, and proven strategies for smooth regulatory approval in India.
CDSCO License for Pyeloscope
Expert guide to securing CDSCO MD5 license for Pyeloscope, covering timelines, costs, documents, and practical tips for Class B urology devices in India.
CDSCO License for Flexible video nephroscope
Expert guidance on obtaining CDSCO MD5 license for Flexible Video Nephroscope (Class B) with timelines, costs, documents, and practical tips to streamline your regulatory journey.
CDSCO License for Rigid video ureterorenoscope
Comprehensive guide to obtaining CDSCO MD5 manufacturing license for Rigid Video Ureterorenoscope (Class B), including timelines, costs, documents, and expert tips.
CDSCO License for Male urinary outflow analysis system
Expert CDSCO license guidance for Male Urinary Outflow Analysis System (Class B) covering timelines, costs, documentation, and practical steps to ensure smooth market entry in India.
CDSCO License for Transobturator needle, reusable
Expert guidance on obtaining CDSCO MD5 license for reusable Transobturator needles (Class B), including timelines, costs, required documents, and practical tips for seamless regulatory approval.
CDSCO License for Intermittent urethral drainage catheter, sterile
Expert guidance on obtaining CDSCO MD5 manufacturing license for sterile intermittent urethral drainage catheters (Class B), covering timelines, documents, costs, and practical tips.
CDSCO License for Penile extracorporeal shock wave therapy system
Expert guidance on obtaining CDSCO MD5 license for Penile extracorporeal shock wave therapy systems (Class B) with detailed timelines, costs, and document requirements.
CDSCO License for Hand-held urinal, male, reusable
Expert guidance on obtaining CDSCO MD5 license for Class A Hand-held male urinal, covering timelines, costs, documents, and practical tips for smooth market entry in India.
CDSCO License for Male urinary outflow analysis system cuff
Comprehensive guide to obtaining CDSCO MD5 license for Male Urinary Outflow Analysis System Cuff (Class B), covering timelines, costs, documents, and practical regulatory insights.
CDSCO License for Urodynamic measurement system
Expert guide for obtaining CDSCO MD5 license for Urodynamic Measurement System (Class B), covering timelines, costs, documents, and practical tips for smooth regulatory approval.
CDSCO License for Flexible ureteral sheath/fibreoptic telescope
Navigate the CDSCO licensing process for Flexible Ureteral Sheath/Fibreoptic Telescope (Class B) with expert guidance on timelines, costs, and documentation for swift market entry.
CDSCO License for Cystometer
Expert guide on obtaining CDSCO MD5 license for Cystometer (Class B device) with detailed timelines, costs, documents, and practical advice for smooth market entry in India.
CDSCO License for Diaphragm wearable urinal
Comprehensive guide for obtaining CDSCO MD5 license for Class A Diaphragm Wearable Urinal devices, detailing process, timelines, costs, and documentation.
CDSCO License for Draping incontinence liner
Comprehensive guide for obtaining CDSCO MD5 license for Draping Incontinence Liner (Class A), covering timelines, costs, documents, and expert tips for smooth regulatory approval.
CDSCO License for Rigid cystourethroscope
Expert guide to CDSCO MD5 license for Rigid Cystourethroscope (Class B) with timelines, costs, documents, and practical tips for smooth regulatory approval.
CDSCO License for Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use
Expert guidance on securing CDSCO MD5 license for Electrohydraulic/Pneumatic Lithotripsy System Probe, Risk Class B device, with detailed timelines, costs, and documentation.
CDSCO License for Flexible endoscopic stone- retrieval forceps, reusable
Expert guidance on obtaining CDSCO MD5 manufacturing license for reusable flexible endoscopic stone-retrieval forceps (Class B) with timelines, costs, and document essentials.
CDSCO License for Microwave hyperthermia system catheter, prostatic- ablation, reusable
Expert guidance on obtaining CDSCO MD9 license for Microwave Hyperthermia System Catheter, including timelines, costs, documentation, and practical steps for Class C urology devices.
CDSCO License for Rigid ureteroscope
Comprehensive guide for obtaining CDSCO MD5 license for Rigid Ureteroscope Class B devices, covering timelines, costs, documentation, and expert insights.
CDSCO License for Flexible fibreoptic nephroscope
Expert guidance on obtaining CDSCO MD5 license for Flexible Fibreoptic Nephroscope (Class B), detailing timelines, costs, documentation, and practical tips for smooth regulatory approval.
CDSCO License for Flexible video cystonephroscope
Navigate the CDSCO licensing process for Flexible Video Cystonephroscopes (Class B) with expert guidance on timelines, costs, documentation, and practical tips.
CDSCO License for Manometric catheter sheath
Expert guidance on obtaining CDSCO MD5 manufacturing license for Manometric Catheter Sheath (Class B) with timelines, costs, documents, and practical tips.
CDSCO License for Electromechanical lithotripsy system, intracorporeal
Expert guidance on obtaining CDSCO MD5 license for Electromechanical Lithotripsy System (Class B) with detailed timelines, costs, documentation, and practical tips.
CDSCO License for Electromechanical lithotripsy system, extracorporeal
Expert guidance on obtaining CDSCO MD5 manufacturing license for Electromechanical Lithotripsy System (Class B), including timelines, costs, documentation, and practical steps.
CDSCO License for Piezoelectric lithotripsy system
Expert guidance on obtaining CDSCO MD9 license for Class C Piezoelectric Lithotripsy Systems with detailed timelines, costs, and document requirements.
CDSCO License for Laser lithotripsy fibre/suction guide
Expert guidance on obtaining CDSCO MD9 manufacturing license for Class C Laser Lithotripsy Fibre/Suction Guide with timelines, costs, documents, and practical tips.
CDSCO License for Cystoscopic electrode
Expert guidance on obtaining CDSCO MD5 manufacturing license for your Class B cystoscopic electrode, detailing timelines, costs, documentation, and practical steps.
CDSCO License for Urinary-incontinence vaginal insert, reusable
Expert guidance on obtaining CDSCO MD5 manufacturing license for Class A urinary-incontinence vaginal inserts with detailed timelines, costs, and document checklist.
CDSCO License for Laser lithotripsy system
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C Laser Lithotripsy Systems, including timelines, costs, and documentation.
CDSCO License for Hepatic function analysis system
Expert guidance on obtaining CDSCO MD5 manufacturing license for Hepatic Function Analysis Systems (Class B medical devices) with detailed timelines, costs, and document requirements.
CDSCO License for Rigid cystoscope
Expert guidance on obtaining CDSCO MD5 license for rigid cystoscopes in India, covering timelines, costs, documentation, and practical regulatory insights.
CDSCO License for Intracorporeal lithotripsy suction system
Expert guidance on obtaining CDSCO MD5 manufacturing license for Intracorporeal Lithotripsy Suction System (Class B) with detailed timelines, costs, and documentation.
CDSCO License for Urethral/suprapubic catheter valve-connector
Expert guidance on obtaining CDSCO MD5 manufacturing license for urethral/suprapubic catheter valve-connectors with timelines, costs, documents, and practical tips.
CDSCO License for Flexible video cystourethroscope
Navigate the CDSCO MD5 licensing process for your Flexible Video Cystourethroscope with expert guidance on timelines, costs, and documentation for Class B urology devices.
CDSCO License for Bladder-emptying vibratory stimulator
Navigate the CDSCO licensing process for your Class B bladder-emptying vibratory stimulator with our expert, step-by-step guide covering timelines, costs, documents, and practical insights.
CDSCO License for Intermittent urethral catheterization kit, non- sterile
Expert guidance on obtaining CDSCO MD5 license for Intermittent Urethral Catheterization Kits (Class B) with detailed timelines, costs, documents, and practical tips.
CDSCO License for Flexible fibreoptic cystoscope
Comprehensive guide for obtaining CDSCO MD5 license for Flexible Fibreoptic Cystoscope (Class B) covering timelines, costs, documents, and expert tips.
CDSCO License for Penile extracorporeal shock wave therapy system applicator
Expert guidance on CDSCO licensing for Penile Extracorporeal Shock Wave Therapy System Applicator, a Class B urology device, covering timelines, costs, documents, and practical tips.
CDSCO License for Flexible video urethroscope
Comprehensive guide for obtaining CDSCO MD5 license for Flexible Video Urethroscope (Class B) with expert timelines, costs, and documentation insights.
CDSCO License for Cystometer probe, ultrasonic
Expert guidance on obtaining CDSCO MD5 license for ultrasonic cystometer probes, covering timelines, costs, documentation, and practical tips for smooth regulatory compliance in India.
CDSCO License for Intermittent urethral catheterization kit, sterile
Expert guidance on obtaining CDSCO MD5 manufacturing license for sterile intermittent urethral catheterization kits, including timelines, costs, and documentation tailored for Class B urology devices.
CDSCO License for Flexible fibreoptic cystonephroscope
Navigate the CDSCO licensing journey for Flexible Fibreoptic Cystonephroscopes with expert guidance on timelines, costs, documents, and practical insights for Class B medical devices in India.
CDSCO License for Hand-held urinal, female
Expert guidance on obtaining CDSCO MD5 license for Class A Hand-held Female Urinal devices, with detailed timelines, costs, and documentation for smooth market entry.
CDSCO License for Closed-ended wearable urine collection bag, non- sterile
Get expert guidance on obtaining your CDSCO MD5 license for Class A closed-ended wearable urine collection bags, with detailed timelines, costs, and document requirements.
CDSCO License for Ultrasonic lithotripsy system
Expert guide to CDSCO licensing for Ultrasonic Lithotripsy Systems (Class B), detailing timelines, costs, documents, and practical steps to streamline your regulatory approval in India.
CDSCO License for Home faecal specimen collection kit
Expert guide on obtaining CDSCO MD5 license for Home Faecal Specimen Collection Kit (Class A), detailing timelines, costs, document checklist, and practical steps for smooth regulatory approval.
CDSCO License for Penis wearable urinal
Expert guidance on obtaining CDSCO MD5 license for Penis Wearable Urinal (Class B) with detailed timelines, costs, documentation, and practical tips for smooth regulatory approval.
CDSCO License for Perineal orifice incontinence-control electrical stimulation system, remote control
Expert guidance on obtaining CDSCO MD9 license for Class C urology devices like perineal orifice incontinence-control electrical stimulation systems with detailed timelines, costs, and document requirements.
CDSCO License for Spark-gap lithotripsy system
Expert guidance on obtaining CDSCO MD5 manufacturing license for Spark-gap lithotripsy systems (Class B) with timelines, costs, and document requirements.
CDSCO License for Flexible video cystoscope, reusable
Navigate CDSCO licensing for your reusable flexible video cystoscope with expert guidance on timelines, costs, documentation, and regulatory compliance.
CDSCO License for General-purpose ureteral catheter
Get expert guidance on obtaining your CDSCO MD5 manufacturing license for a Class B general-purpose ureteral catheter, including timelines, costs, and document requirements.
CDSCO License for Female wearable urinal, reusable
Expert guidance on obtaining CDSCO MD5 license for Female Wearable Urinal (Class A), detailing timelines, costs, documentation, and practical steps for Indian market entry.
CDSCO License for Flexible video ureterorenoscope, reusable
Expert guidance on obtaining CDSCO MD5 license for Flexible Video Ureterorenoscope, Class B device, with detailed timelines, costs, documents, and practical tips for smooth approval.
CDSCO License for Flexible fibreoptic urethroscope
Comprehensive guide for obtaining CDSCO MD5 license for Flexible Fibreoptic Urethroscope (Class B) with timelines, costs, and document insights.
CDSCO License for Incontinence device suspender
Expert guide to obtaining CDSCO MD5 license for Incontinence Device Suspenders (Class A) with detailed timelines, costs, document requirements, and practical tips for seamless market entry.
CDSCO License for Closed-ended wearable urine collection bag, sterile
Expert guidance on obtaining CDSCO MD5 license for sterile closed-ended wearable urine collection bags, covering timelines, costs, documents, and practical tips for Class A devices.
CDSCO License for Filiform urethral bougie
Expert guide to obtaining a CDSCO MD5 manufacturing license for Filiform urethral bougie, covering timelines, costs, documents, and practical tips for Class B urology devices.
CDSCO License for Incontinence sensor/alarm
Expert guide to obtaining CDSCO MD5 license for Incontinence Sensor/Alarm (Class B) detailing timelines, costs, document requirements, and practical steps for smooth regulatory approval.
CDSCO License for Ureteral patency kit
Expert guide to obtaining a CDSCO MD5 manufacturing license for Class B Ureteral Patency Kits, including timelines, costs, documents, and practical tips.
CDSCO License for Rigid ureterorenoscope
Navigate the CDSCO licensing process for your Class B rigid ureterorenoscope with expert insights on timelines, costs, documents, and practical steps for seamless market entry in India.
CDSCO License for Biliary/urinary stone retrieval basket
Get expert guidance on obtaining your CDSCO MD5 manufacturing license for Biliary/Urinary Stone Retrieval Basket (Class B device) with detailed timelines, costs, and documentation.
CDSCO License for Penis/scrotum wearable urinal
Expert guidance on obtaining CDSCO MD5 license for Class B Penis/Scrotum Wearable Urinal devices with detailed timelines, costs, and document requirements.
CDSCO License for Rigid nephroscope
Expert guidance on obtaining CDSCO MD5 license for rigid nephroscopes, covering timelines, costs, documents, and practical tips to succeed in India's regulatory landscape.
CDSCO License for Incontinence penis clamp, reusable
Expert guidance on obtaining CDSCO MD5 license for incontinence penis clamps (Class A), including timelines, costs, and document requirements for smooth market entry.
CDSCO License for Lithotrite
Navigate the CDSCO licensing process for your Class B Lithotrite device with expert guidance on timelines, costs, and documentation to ensure smooth market entry in India.
CDSCO License for Hydraulic male urinary incontinence treatment system
Expert guide for obtaining CDSCO MD9 license for Hydraulic Male Urinary Incontinence Treatment Systems, detailing timelines, costs, documentation, and practical steps for Class C urology devices.
CDSCO License for Intraurethral valve/pump
Expert guidance on obtaining CDSCO MD5 manufacturing license for intraurethral valve/pump (Class B urology device) with detailed timelines, costs, and documentation.
CDSCO License for Flexible fibreoptic ureteroscope
Navigate the CDSCO licensing process for Flexible Fibreoptic Ureteroscope Class B devices with expert guidance on timelines, costs, and document requirements.
CDSCO License for Flexible fibreoptic ureterorenoscope
Navigate the CDSCO licensing process for Flexible Fibreoptic Ureterorenoscopes (Class B) with expert guidance on timelines, costs, documents, and practical tips for Indian market entry.
CDSCO License for Urethral drainage catheter punch
Expert guidance on obtaining CDSCO MD5 license for urethral drainage catheter punch, including timelines, costs, documents, and practical tips for Class B medical devices in urology.
CDSCO License for Transvaginal needle, surgical
Expert guidance on obtaining CDSCO MD5 license for Transvaginal Needle, surgical (Class B) with detailed timelines, costs, documents, and practical tips for seamless approval.
CDSCO License for Bare-metal urethral stent, short-term
Navigate the CDSCO licensing process for your Class C bare-metal urethral stent with expert insights on timelines, costs, documentation, and compliance for smooth market entry in India.
CDSCO License for Bladder neck spreader
Expert guide to obtaining CDSCO MD5 license for Bladder Neck Spreader, covering timelines, costs, documentation, and practical steps for Class A urology devices.
CDSCO License for Intermittent urethral drainage catheter, antimicrobial
Expert guidance on obtaining CDSCO MD5 manufacturing and MD15 import licenses for antimicrobial intermittent urethral drainage catheters (Class B). Timelines, costs, documents detailed.
CDSCO License for Hydraulic male urinary incontinence treatment system port
Expert guidance on obtaining CDSCO MD9 license for Hydraulic male urinary incontinence treatment system port, detailing timelines, costs, documents, and practical steps for Class C devices.
CDSCO License for Hydraulic male urinary incontinence treatment system tubing plug
Navigate CDSCO licensing for your Class C hydraulic male urinary incontinence tubing plug with expert timelines, costs, and document guidance tailored to urology devices.
CDSCO License for Fibreoptic ureteral catheter, reusable
Expert guidance on obtaining a CDSCO MD5 manufacturing license for reusable fibreoptic ureteral catheters (Class B), including timelines, costs, and documentation.
CDSCO License for Intermittent urethral drainage catheter, non- sterile
Expert guidance on obtaining CDSCO MD5 license for Class B intermittent urethral drainage catheters, detailing timelines, costs, documentation, and practical regulatory insights.
CDSCO License for Temperature-monitoring indwelling urethral drainage catheter
Navigate CDSCO licensing for Temperature-monitoring Indwelling Urethral Drainage Catheters with expert guidance on timelines, costs, and documentation for Class B devices.