Posted by For businesses and individuals operating or trying to enter into the Indian urology device market, obtaining a CDSCO urology medical devices license is the first mandatory step. The Drugs Controller General of India (DCGI) under the Central Drugs Standard Control Organisation (CDSCO) regulates all medical devices, including urological equipment.
Classified under the Medical Devices Rules, 2017, each Medical device requires an approval in the form of a license for marketing and use in India. Whether you are a manufacturer or importer, complying with the CDSCO urology medical devices guidelines is essential to obtain a license and start your business. Read on to understand these guidelines in detail and how Dueran Consultants can help and support you.
What are Urology Medical Devices in India?
Urology medical devices in India are a part of the various categories notified by CDSCO in recent years. Equipment used in clinical settings, like Rigid cystoscope, Rigid urethroscope and urinary incontinence products, comes under the regulatory ambit.
CDSCO classified various types of urology instruments into low-risk and high-risk devices. Some examples are given below:
- Class A (low-risk): Bladder-neck spreader; Urine Collection bags; Incontinence device suspender.
- Class B (moderate risk): Biliary/urinary stone retrieval basket; Intermittent urethral drainage catheter, sterile.
- Class C (moderate‑high risk): Bare-metal urethral stent, short-term; Laser lithotripsy system
Who Can Apply for the CDSCO Urological Medical License in India?
The CDSCO urological medical device license can be applied by an entity involved in the manufacturing, importing, or distribution of urology devices for sale or use in the country.
Eligibility is based on your role in the supply chain and adherence to the Medical Devices Rules, 2017. The following can apply for the license:
- Indian manufacturers of urological medical devices – For Class A and B devices, apply to the State Licensing Authority (SLA). For Class C and D devices, apply to the Central Licensing Authority (CLA) at CDSCO.
- Foreign manufacturers – Foreign manufacturers desiring to supply urology medical devices in India must have an Indian Authorized Agent (IAA).
- Authorised Indian agents or license holders – Authorized Indian Agents holding a valid wholesale or manufacturing license under the Medical Devices Rules, 2017 can apply on behalf of foreign manufacturers.
- Distributors for market expansion – While distributors themselves cannot sell urology Medical devices without License. However, they can operate under the import or manufacturing license that is owned by the principal entity.
CDSCO Classification of Urology Medical Devices
CDSCO classifies all urological medical devices based on risk-based categories. Under the Medical Devices Rules formed in 2017, CDSCO has created the following classification:
- Class A: Low risk
- Class B: Low-to-moderate risk
- Class C: Moderate-to-high risk
- Class D: High risk
You can easily find out the risk class using this table, which shows the device-wise CDSCO urological medical device classification:
|
S. No |
Medical Device Names |
Risk Class |
| 1 | Bare-metal urethral stent, short-term | C |
| 2 | Biliary/urinary stone retrieval basket | B |
| 3 | Bladder neck spreader | A |
| 4 | Bladder-emptying vibratory stimulator | B |
| 5 | Closed-ended wearable urine collection bag, non- sterile | A |
| 6 | Closed-ended wearable urine collection bag, sterile | A |
| 7 | Cystometer | B |
| 8 | Cystometer probe, ultrasonic | B |
| 9 | Cystoscopic electrode | B |
| 10 | Diaphragm wearable urinal | A |
| 11 | Draping incontinence liner | A |
| 12 | Drip wearable urinal | A |
| 13 | Electrohydraulic lithotripsy system | B |
| 14 | Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use | B |
| 15 | Electromechanical lithotripsy system, extracorporeal | B |
| 16 | Electromechanical lithotripsy system, intracorporeal | B |
| 17 | Female wearable urinal, reusable | A |
| 18 | Fibreoptic ureteral catheter, reusable | B |
| 19 | Filiform urethral bougie | B |
| 20 | Flexible endoscopic stone- retrieval forceps, reusable | B |
| 21 | Flexible fibreoptic cystonephroscope | B |
| 22 | Flexible fibreoptic cystoscope | B |
| 23 | Flexible fibreoptic cystourethroscope | B |
| 24 | Flexible fibreoptic nephroscope | B |
| 25 | Flexible fibreoptic ureterorenoscope | B |
| 26 | Flexible fibreoptic ureteroscope | B |
| 27 | Flexible fibreoptic urethroscope | B |
| 28 | Flexible ureteral sheath/fibreoptic telescope | B |
| 29 | Flexible video cystonephroscope | B |
| 30 | Flexible video cystoscope, reusable | B |
| 31 | Flexible video cystourethroscope | B |
| 32 | Flexible video nephroscope | B |
| 33 | Flexible video ureterorenoscope, reusable | B |
| 34 | Flexible video ureteroscope, reusable | B |
| 35 | Flexible video urethroscope | B |
| 36 | General-purpose ureteral catheter | B |
| 37 | Hand pneumatic lithotripsy system, urinary | B |
| 38 | Hand-held urinal, female | A |
| 39 | Hand-held urinal, male, reusable | A |
| 40 | Hepatic function analysis system | B |
| 41 | Home faecal specimen collection kit | A |
| 42 | Hydraulic male urinary incontinence treatment system | C |
| 43 | Hydraulic male urinary incontinence treatment system port | C |
| 44 | Hydraulic male urinary incontinence treatment system tubing | C |
| 45 | Hydraulic male urinary incontinence treatment system tubing plug | C |
| 46 | Incontinence device suspender | A |
| 47 | Incontinence penis clamp, reusable | A |
| 48 | Incontinence sensor/alarm | B |
| 49 | Inflatable penile prosthesis | C |
| 50 | Intermittent urethral catheterization kit, non- sterile | B |
| 51 | Intermittent urethral catheterization kit, sterile | B |
| 52 | Intermittent urethral drainage catheter, antimicrobial | B |
| 53 | Intermittent urethral drainage catheter, non- sterile | B |
| 54 | Intermittent urethral drainage catheter, sterile | B |
| 55 | Intracorporeal lithotripsy suction system | B |
| 56 | Intraurethral valve/pump | B |
| 57 | Laser lithotripsy fibre/suction guide | C |
| 58 | Laser lithotripsy system | C |
| 59 | Lithotrite | B |
| 60 | Male urinary outflow analysis system | B |
| 61 | Male urinary outflow analysis system cuff | B |
| 62 | Manometric catheter sheath | B |
| 63 | Microwave hyperthermia system catheter, prostatic- ablation, reusable | C |
| 64 | Penile extracorporeal shock wave therapy system | B |
| 65 | Penile extracorporeal shock wave therapy system applicator | B |
| 66 | Penis wearable urinal | B |
| 67 | Penis/scrotum wearable urinal | B |
| 68 | Perineal orifice incontinence-control electrical stimulation system, remote control | C |
| 69 | Piezoelectric lithotripsy system | C |
| 70 | Pyeloscope | B |
| 71 | Rigid cystoscope | B |
| 72 | Rigid cystourethroscope | B |
| 73 | Rigid nephroscope | B |
| 74 | Rigid ureterorenoscope | B |
| 75 | Rigid ureteroscope | B |
| 76 | Rigid urethroscope | B |
| 77 | Rigid video ureterorenoscope | B |
| 78 | Spark-gap lithotripsy system | B |
| 79 | Suprapubic needle, surgical, reusable | B |
| 80 | Temperature-monitoring indwelling urethral drainage catheter | B |
| 81 | Transobturator needle, reusable | B |
| 82 | Transvaginal needle, surgical | B |
| 83 | Ultrasonic lithotripsy system | B |
| 84 | Ureteral patency kit | B |
| 85 | Urethral drainage catheter punch | B |
| 86 | Urethral/suprapubic catheter valve-connector | A |
| 87 | Urinary-incontinence vaginal insert, reusable | A |
| 88 | Urodynamic measurement system | B |
Why You Need a CDSCO License for Urology Medical Devices?
Once a part of the notified list, each urological medical device license in India (whether for manufacturing or import) must be secured. Otherwise, you cannot do its marketing.
The license is significant because it ensures the following:
- The device’s compliance with quality and safety norms
- Public health protection
- Legal and unquestionable access to the market
- Credible global-standard certification
Key Steps: CDSCO Urology Medical Devices Registration & Import License
Import license for urology medical devices, the following guides are essential to follow.
1. Risk Classification
Identify the risk class (A/B/C/D) for your urology medical device. For this, check the CDSCO’s official list.
2. Indian Authorized Agent (IAA)
Foreign OEMs must appoint an Indian Authorized Agent before starting this process. The IAA is registered as a legal entity in India and represents you locally before CDSCO. Also, the IAA will apply for an import license (Form MD‑15) on behalf of the manufacturer, for which the key requirements are as follows:
- Free Sale Certificate (FSC) from the country of origin and regulated countries like EU/USA/Japan/Canada/United Kingdom/ Australia.
- Regulatory approvals like an ISO 13485 Certificate from recognised bodies
- DMF and PMF in the prescribed CDSCO format.
3. Registration at Medical Device Sugam Portal
Registration and license submission happen through the e-governance MD Sugam portal. It is CDSCO’s official online platform for application, tracking, and uploading of documentation.
NOTE: A Foreign manufacturing unit cannot register on the MD Sugam portal directly. The Indian agent will create login credentials on behalf ofthe Foreign manufacturing unit, which can be further used for signing.
- Sign up on cdscomdonline.gov.in
- In the new window, choose the purpose of registration.
- Click Submit, and you will see the registration form.
- Create a username and password. Your username will be your corporate email ID. It should be distinct and you can use it as a username for the future filing.
- Upload the needed documents in PDF format.
- If you want to get SMS alerts, select the checkbox for it. You will receive messages related to registration and account verification via SMS.
- Click Submit and find the confirmation link in your registered email.
- The moment you tap the verification link, your application will go to the CDSCO officials, who will initiate the process for approval of login credential.
- Once the login credential gets approved, an email will be sent to your email ID.
- If the application is rejected, you will get a rejection email.
4. Prepare Documentation
Common documents include:
- Form MD‑14 in prescribe format
- ISO 13485 certification
- Declaration of conformity
- Free Sale Certificate (for imports)
- Device Master File (DMF), Plant Master File (PMF)
- CE or equivalent certification
- Quality assurance certificates,
- TR6 challan,
- Power of attorney, etc.
5. License Grant & Fees
Upon approval of your application, the CDSCO urology medical devices license is issued.
- Manufacturing and import licenses have an indefinite validity period
- Renewal or license retention fees should be given every five years.
How Dueran Consultant Helps You?
As a top medical device regulatory consultant, we provide end-to-end support and guidance for the CDSCO urological medical device license and registration in India. Our experts have been helping domestic manufacturers and importers with the licensing process, document preparation, online registration, and post-approval support. We not only ease this complex and lengthy process for you, but also provide strategies to grow your business with full compliance in India. You can schedule a consultation with the Dueran Consultant team and learn more about the different ways we can help you.
Frequently Asked Questions (FAQ’s)
1. What are the new innovations in urology?
The latest innovations in urology include AI-assisted surgical planning and surgery, Augmented Reality (AR) supported tumour removal, telemedicine and telesurgery, among others.
2. What is the future of urology?
The future of urology can be characterised by precision-based, patient-specific care and extensive AI use for diagnostics and minimally invasive treatments. Robotics and augmented reality within surgery will also assist with precise outcomes.
3. What equipment is used in urology?
Common urology equipment is urine analysers, cystoscopes, laparoscopes, and specialised equipment like urodynamic systems.
4. How big is the urology market?
The urology market in India is currently valued at $1.19 billion in 2024 and is projected to reach around $2.26 billion by 2033. This market is increasing at a CAGR of 7–9%.
5. What is urology technology?
Urology technology is a term for medical devices and advanced techniques for detecting, treating, and monitoring diseases of the urinary tract and male reproductive system. The technologies that are most used today are robotic-assisted surgery, AI-powered diagnostics, advanced imaging (MRI, CT, ultrasound), and minimally invasive endoscopy.
