A CDSCO urological medical device license is mandatory under India's Medical Devices Rules, 2017 for any manufacturer or importer of notified urological devices — including urine drainage catheters, foley balloon catheters, cystoscopes, lithotripsy systems, ureteral stents, and irrigation sets. Urological devices span Class A through Class D. Manufacturing Class A and B devices requires a Form MD5 license from the State Licensing Authority (fee: Rs. 5,000 plus Rs. 500 per device). Manufacturing Class C and D devices requires a Form MD9 license from CDSCO Central (fee: Rs. 50,000 plus Rs. 1,000 per device). Importing any class requires a Form MD15 import license from CDSCO. All three license types are valid indefinitely, subject to a retention fee paid every 5 years — non-payment results in automatic cancellation. Applications are submitted through the CDSCO SUGAM portal (cdscoonline.gov.in). ISO 13485 certification and a Device Master File are mandatory for all manufacturing license applications.
Urology is the medical specialty concerned with the health of the urinary system — the kidneys, ureters, bladder, and urethra — as well as male reproductive health, encompassing conditions of the penis, testes, scrotum, and prostate. Urological conditions span a wide clinical range: kidney stones, urinary tract infections, benign prostatic hyperplasia, urinary incontinence, urological cancers, and erectile dysfunction. Urological medical devices serve this broad landscape — from simple continence management products such as wearable urinals and incontinence liners through complex diagnostic instruments such as flexible video cystoscopes, to advanced therapeutic systems such as lithotripters and implantable sacral nerve stimulators.
Urology is among the fastest-growing medical specialties in India, driven by an expanding population of older adults, rising rates of diabetes and hypertension that directly increase kidney stone and urinary dysfunction risk, and growing public awareness of treatable urological conditions. As more specialist urology centres open and the breadth of urological interventions available across India widens, the demand for the full spectrum of urological medical devices — diagnostic, therapeutic, and surgical — is growing commensurately. CDSCO's regulatory framework for this device category is designed to ensure that this growing demand is met by devices that meet the quality, safety, and performance standards India's patients require. Securing the applicable CDSCO urological medical device license is a legal prerequisite for any manufacturer or importer who intends to participate in this market.
📑 Quick Navigation
- India's Urological Medical Device Market
- CDSCO Regulations for Urological Devices: Mandatory Compliance
- CDSCO Classification: Urological Devices by Class
- Mandatory Documents for CDSCO Urological Device License
- Three CDSCO License Types: MD5, MD9, MD15
- 5-Step Application Process Through CDSCO SUGAM
- License Validity and Retention Fee Requirements
- 5 Benefits of CDSCO Licensing for Urological Device Manufacturers
- How Rego Services Supports Your CDSCO Application
- Frequently Asked Questions
India's Urological Medical Device Market
India's urological device market is one of the more commercially attractive segments within the country's broader medical device landscape. The Indian urology market is projected to reach approximately USD 600 million by 2029, growing at a compound annual rate of around 9% from 2024 — a trajectory that reflects both the depth of unmet urological care needs and the structural factors accelerating the market's development.
The market spans four principal product segments: stone management devices (including lithotripsy systems and stone retrieval baskets), benign prostate hyperplasia treatment devices, erectile dysfunction treatment devices, and urinary incontinence devices. Each of these segments is driven by a distinct but overlapping set of epidemiological and demographic factors. Kidney stone prevalence in India is among the highest globally, driven by dietary patterns, water quality variation, and high ambient temperatures in many regions — generating sustained demand for lithotripsy systems, stone retrieval baskets, and ureteral stents at scale. Benign prostatic hyperplasia is nearly universal among men over 60 and increasingly symptomatic among those over 50, and India's ageing male population is expanding this addressable patient group every year. Urinary incontinence, historically undertreated due to social stigma, is increasingly being addressed by specialist clinics, expanding demand for both conservative management devices and surgical treatment options.
Several structural drivers are reinforcing this growth trajectory beyond the baseline disease burden. Government schemes promoting domestic medical device production — including the Production Linked Incentive (PLI) scheme for medical devices — are incentivising domestic manufacturing investment, including in urological device categories. Increasing numbers of dedicated urology clinics and specialist centres, particularly in Tier 2 and Tier 3 cities, are expanding the geographic footprint of addressable demand well beyond the metropolitan centres where specialist urology was previously concentrated. Growing health insurance penetration is reducing the financial barrier that previously prevented many patients from accessing advanced urological interventions, expanding the commercial market for higher-value devices such as laser lithotripsy systems and hydraulic incontinence treatment systems. For medical device companies that engage seriously with CDSCO's licensing requirements, India's urology device market offers a combination of scale, growth, and underserved demand that is difficult to match elsewhere.
CDSCO Regulations for Urological Devices: Mandatory Compliance
CDSCO's regulatory oversight of urological medical devices is grounded in the same risk-proportionate logic that governs all medical device regulation under the Medical Devices Rules, 2017. Urological devices collectively present a wide and varied risk profile — from low-risk continence management accessories that pose minimal patient safety risk if they underperform, through moderate-risk diagnostic instruments such as flexible cystoscopes whose performance directly affects the accuracy of clinical findings, to high-risk implantable devices such as artificial urinary sphincters and sacral nerve stimulators where device failure can have serious and irreversible consequences for the patient's quality of life and health.
CDSCO requires all manufacturers and importers of notified urological devices to obtain the applicable license before any manufacturing or import activity commences. This is a legally enforceable obligation under the Drugs and Cosmetics Act and the Medical Devices Rules, 2017 — not a voluntary compliance step. Operating without the applicable license exposes manufacturers and importers to enforcement action, product seizure, and reputational risk with the hospital, clinic, and distributor partners on whom commercial success in India's urology market depends.
CDSCO Classification: Urological Devices by Class
All notified urological medical devices fall within one of four CDSCO risk classes — A (lowest risk) through D (highest risk). Understanding the correct class for a specific device is the essential first step in any licensing process, since it determines which license type applies, which authority issues the license, and what fee structure governs the application. The following provides real device examples across all four classes.
- Bladder neck spreader
- Closed-ended wearable urine collection bag, non-sterile
- Closed-ended wearable urine collection bag, sterile
- Diaphragm wearable urinal
- Draping incontinence liner
- Drip wearable urinal
- Female wearable urinal, reusable
- Hand-held urinal, female
- Hand-held urinal, male, reusable
- Incontinence device suspender
- Incontinence pants liner
- Incontinence pants, reusable
- Incontinence penis clamp, reusable
- Home faecal specimen collection kit
- Biliary/urinary stone retrieval basket, reusable
- Bladder-emptying vibratory stimulator
- Cystometer / cystometer probe (ultrasonic)
- Cystoscopic electrode
- Electrohydraulic lithotripsy system
- Electromechanical lithotripsy system, intracorporeal
- Fibreoptic ureteral catheter, reusable
- Filiform urethral bougie
- Flexible video cystoscope, reusable
- Flexible fibreoptic nephroscope
- Flexible video ureteroscope, reusable
- Flexible video ureterorenoscope, reusable
- General-purpose ureteral catheter
- Incontinence sensor / alarm
- Hand pneumatic lithotripsy system, urinary
- Bare-metal urethral stent, short-term
- Electromechanical lithotripsy system, extracorporeal
- Hydraulic male urinary incontinence treatment system
- Hydraulic male urinary incontinence treatment system port
- Hydraulic male urinary incontinence treatment system tubing
- Hydraulic male urinary incontinence treatment system tubing plug
- Laser lithotripsy system
- Laser lithotripsy fibre / suction guide
- Implantable sacral nerve electrical stimulation system for bladder/bowel control
- Artificial urinary sphincter (implantable)
- Drug-eluting ureteral stent
- Bioabsorbable ureteral stent, long-term
- Implantable penile prosthesis
- Implantable urethral bulking agent delivery system
- Permanently implantable urological electrostimulation system
Mandatory Documents for CDSCO Urological Device License Application
A well-prepared, complete document set is the principal factor determining whether a CDSCO urological device license application moves through review efficiently or accumulates reviewer queries and delays. The following documents are required for all MD5, MD9, and MD15 urological device license applications, with the level of technical detail expected scaling with device risk class.
- Organisation identity proof — Certificate of Incorporation, Memorandum and Articles of Association, GST registration certificate, and other applicable documents establishing the legal identity and standing of the applicant company in India.
- Sale Deed or Rent Deed of the premises — Valid documentary evidence of the applicant's legal right to occupy the manufacturing facility or registered premises declared in the application.
- Building Layout with dimension — An accurate, dimensioned floor plan of the manufacturing facility showing production areas, quality control laboratory, storage areas, clean zones (relevant for sterile urological device manufacturing), and personnel facilities, prepared in accordance with CDSCO requirements.
- Plant Master File (PMF) — A comprehensive document describing the manufacturing facility's location, layout, process flows, manufacturing equipment, calibration and maintenance programme, environmental monitoring systems, and quality management infrastructure. For Class C and D urological devices — including implantable systems and drug-eluting stents — the PMF must demonstrate full GMP compliance consistent with sterile implantable device manufacturing requirements.
- Device Master File (DMF) — A comprehensive technical dossier covering the urological device's design history, intended use and indications, manufacturing process, risk management file (prepared to ISO 14971), biocompatibility testing data (prepared to ISO 10993, critically important for devices in sustained contact with the urinary tract mucosa or bladder wall), performance and accuracy testing data, sterility and shelf-life data (for sterile devices), labelling and Instructions for Use, and post-market surveillance plan.
- Documents for the team of qualified staff — Curriculum vitae, qualifications, and appointment letters for personnel responsible for manufacturing and testing the urological devices, demonstrating that CDSCO's minimum qualification requirements for manufacturing and quality control personnel are met.
- Environmental regulation compliance documents — Applicable Pollution Control Board clearances and waste disposal documentation, particularly relevant for manufacturing facilities that generate regulated waste streams from device testing or sterilisation processes.
- Certificate of Analysis of 3 consecutive batches — Documentary proof that the manufacturing process consistently produces urological devices meeting all declared specifications. For first-time manufacturers without existing licensed production, these batches must be produced under a prior CDSCO MD13 test license.
- ISO 13485 Certificate — A current, in-scope certificate from an IAF-accredited certification body covering the manufacturing activities relevant to the urological device being licensed. This is a mandatory hard requirement for both MD5 and MD9 applications.
- Test License, if required for testing the device — Where production batches were manufactured under an MD13 test license prior to the permanent license application, a copy of that test license is required to contextualise the batch data submitted in support of the application.
For Class C and D urological devices — laser lithotripsy systems, hydraulic incontinence treatment systems, implantable sacral nerve stimulators, drug-eluting ureteral stents, and artificial urinary sphincters — the biocompatibility testing data and risk management file within the Device Master File receive particularly close CDSCO scrutiny. Devices that remain in sustained contact with the urinary tract mucosa or bladder wall, or that are permanently implanted, must demonstrate biocompatibility to the relevant ISO 10993 endpoints for the specific tissue contact type and duration. Risk management documentation prepared to ISO 14971 must address the specific failure modes and hazards applicable to the device's mechanism of action and implant or intraluminal position.
CDSCO Medical Device Test License (MD13 / MD17) India 2026 — Complete Guide
If you are a first-time manufacturer of urological medical devices and need to produce the three consecutive batch Certificate of Analysis required for your MD5 or MD9 application, an MD13 test license is the legally required first step before licensed production can begin. This guide covers the complete test license process — mandatory documents, the 5-step SUGAM application, and validity rules.
Three CDSCO License Types: MD5, MD9, MD15
Three distinct CDSCO license types apply to urological medical devices, determined by whether the applicant is manufacturing or importing, and — for manufacturers — the risk class of the specific device being licensed.
Manufacturing Class A and B urological devices — such as wearable urine collection bags, incontinence pants, cystoscopes, and stone retrieval baskets — requires an MD5 license with a fee of Rs. 5,000 plus Rs. 500 for each distinct device, obtained from the State Licensing Authority. Manufacturing Class C and D urological devices — such as laser lithotripsy systems, hydraulic incontinence treatment systems, implantable sacral nerve stimulators, and artificial urinary sphincters — requires an MD9 license with a fee of Rs. 50,000 plus Rs. 1,000 for each distinct device, obtained from CDSCO's Central Licensing Authority. Importing urological devices of any class into India requires an MD15 import license from CDSCO Central.
5-Step Application Process Through CDSCO SUGAM
The CDSCO urological medical device license application follows a defined five-step process, filed entirely through the CDSCO SUGAM online portal at cdscoonline.gov.in.
Compile all mandatory documents — organisation identity proof, premises documents, building layout, Plant Master File, Device Master File, qualified personnel documentation, environmental compliance documents, Certificate of Analysis for three consecutive batches, ISO 13485 certificate, and test license if applicable. For Class C and D urological devices, the Device Master File must include a complete ISO 14971 risk management file and ISO 10993 biocompatibility data covering all relevant tissue contact endpoints. Every document must be internally reviewed for completeness, consistency, and compliance with CDSCO format requirements before submission.
File the application online on CDSCO's official SUGAM portal at cdscoonline.gov.in, selecting the applicable license form — MD5, MD9, or MD15 — based on the confirmed device classification. Attach all required supporting documents in the formats and file sizes specified by the portal, and pay the applicable government fee. Common procedural errors at this stage — incorrect form selection, missing document attachments, or fee calculation errors — generate avoidable delays that can set an application timeline back by weeks.
CDSCO reviewers may raise written queries on the submitted application through the SUGAM portal. For Class C and D urological device applications, queries most frequently relate to the Device Master File's biocompatibility testing data, sterility validation, risk management scope, and performance testing methodology. Queries must be addressed promptly and with precision — delayed, incomplete, or unclear responses are the most common driver of extended application timelines in this device category.
For manufacturing license applications (MD5 and MD9), CDSCO regulatory officials may visit the manufacturing facility to verify that the premises, manufacturing processes, quality systems, and personnel qualifications declared in the Plant Master File and Device Master File reflect actual conditions. For Class C and D implantable urological device manufacturers, inspection preparedness — including demonstrable GMP implementation, validated sterilisation processes, and controlled environment compliance — is a critical factor in achieving a successful inspection outcome.
Once all criteria are satisfied — reviewer queries fully resolved and any inspection findings addressed — CDSCO grants the applicable urological medical device license: Form MD5, MD9, or MD15, issued through the SUGAM portal. The license is specific to the device(s) and manufacturing premises declared in the application, and is granted in the applicant's name.
License Validity and Retention Fee Requirements
The CDSCO urological medical device license is valid indefinitely from the date of grant. However, the license retention fee must be paid every 5 years — failure to do so results in automatic cancellation of the license, requiring a completely fresh application to resume any manufacturing or import activity.
| Parameter | MD5 — Class A/B Manufacture | MD9 — Class C/D Manufacture | MD15 — Import All Classes |
|---|---|---|---|
| Validity | Indefinite | Indefinite | Indefinite |
| Retention fee cycle | Every 5 years | Every 5 years | Every 5 years |
| Effect of non-payment | Automatic cancellation | Automatic cancellation | Automatic cancellation |
| Issuing authority | State Licensing Authority | CDSCO (Central) | CDSCO (Central) |
| Initial license fee | Rs. 5,000 + Rs. 500/device | Rs. 50,000 + Rs. 1,000/device | Class-dependent |
5 Benefits of CDSCO Licensing for Urological Device Manufacturers
A valid CDSCO license is the legal prerequisite for placing urological devices on the Indian market — a segment characterised by a large and growing underlying disease burden across kidney stones, BPH, urinary incontinence, and urological cancers, combined with expanding specialist infrastructure to serve it. Licensing converts this commercial opportunity into a legally accessible channel, while ensuring the manufacturer competes on quality and regulatory standing rather than through unlicensed short-cuts that expose both patients and the business to unacceptable risk.
Urologists and hospital procurement teams evaluating suppliers of cystoscopes, lithotripsy systems, ureteral stents, and incontinence treatment devices apply rigorous due diligence to device quality and regulatory status. CDSCO licensing — backed by ISO 13485 certification and comprehensive Device Master File documentation — signals that a manufacturer's products have been independently reviewed against defined quality and safety standards, strengthening commercial negotiations and enabling inclusion on hospital approved supplier lists.
Urological devices imported without a valid CDSCO MD15 license face customs detention and potential seizure at Indian ports of entry. For hospitals and urology centres relying on regular consignments of lithotripsy consumables, ureteral catheters, or cystoscopy accessories, even a short customs delay can disrupt clinical schedules. A valid MD15 license ensures that imported urological devices clear customs without complication, supporting the reliable supply continuity that clinical and commercial partners require.
India's government hospitals and health schemes represent a substantial and stable procurement channel for urological devices — particularly for stone management and continence care devices, where government programmes are actively expanding access. CDSCO licensing is a mandatory eligibility condition for supply to government hospitals, central procurement authorities, and empanelled scheme providers. Manufacturers and importers with valid licenses can participate in government tenders and supply agreements that are entirely inaccessible to unlicensed competitors.
With the Indian urology market growing at approximately 9% annually, driven by demographics, rising disease incidence, and expanding specialist infrastructure, the commercial opportunity for urological device manufacturers is durable rather than cyclical. A CDSCO license with indefinite validity provides the long-term regulatory foundation from which manufacturers can scale their urological device portfolio — adding new device categories, higher-risk therapeutic devices, and consumable ranges — as their India market position and clinical relationships develop over time.
CDSCO Nephrology Medical Device License India 2026 — Complete Guide
Urological device manufacturers whose portfolio also includes nephrology devices — haemodialysis systems, peritoneal dialysis products, or kidney stone management devices classified under the nephrology category — should review the CDSCO licensing requirements for the nephrology device category, which apply alongside urological device licensing for any products classified within that schedule.
How Rego Services Supports Your CDSCO Application
Securing the CDSCO urological medical device license is a substantive regulatory undertaking that requires precise device classification, thorough preparation of technically demanding documents, and disciplined management of the SUGAM portal submission and review process. For Class C and D urological devices — implantable systems, laser lithotripsy equipment, and hydraulic incontinence treatment systems — the documentation requirements are particularly demanding, with biocompatibility testing data and risk management files subject to close CDSCO reviewer scrutiny. Rego Services Private Limited provides end-to-end support for CDSCO urological medical device license applications across all device classes and license types.
- Device classification confirmation and licensing strategy — We confirm the CDSCO class of your urological device, identify the applicable license type (MD5, MD9, or MD15), and assess whether an MD13 test license is required before the permanent license application can be filed.
- ISO 13485 certification support — Where ISO 13485 certification is not yet in place, we support the full certification process on a timeline coordinated with the CDSCO license application to avoid unnecessary elapsed time between certification and license grant.
- Device Master File preparation — We prepare comprehensive Device Master Files for urological devices, with particular emphasis on ISO 10993 biocompatibility testing data for devices in contact with the urinary tract, ISO 14971 risk management files, and sterility and shelf-life documentation for sterile urological products.
- Plant Master File preparation — We prepare Plant Master Files that accurately and fully describe the manufacturing facility — including GMP compliance evidence, validated sterilisation processes (for sterile urological devices), and environmental monitoring data — to the standard CDSCO reviewers and inspectors expect.
- Batch production and Certificate of Analysis support — We support the planning and documentation of the three consecutive batch production runs required for MD5 and MD9 applications, including coordination with test license requirements for first-time urological device manufacturers.
- SUGAM portal submission management — We manage the complete online application process — form selection, document upload, fee payment, and formal submission — eliminating procedural errors that generate avoidable delays.
- Query response and inspection preparation — We draft responses to CDSCO reviewer queries and prepare manufacturing facilities for CDSCO inspection, drawing on our direct experience of the query patterns and inspection focus areas most commonly encountered in urological device applications.
- Post-grant compliance and retention fee management — We maintain retention fee compliance calendars and provide ongoing CDSCO compliance support after license grant, helping you maintain active license status and avoid the automatic cancellation risk associated with missed retention fee deadlines.
Frequently Asked Questions
Does a single MD15 import license cover all urological device products, or is a separate license required for each device?
A single MD15 import license can cover multiple distinct urological device products, provided each distinct product is individually declared in the application and the applicable per-device fee is paid for each one. Importers planning to bring multiple urological products — for example, a flexible video cystoscope, a laser lithotripsy fibre, and a ureteral stent — into India should compile a complete product inventory and confirm the notified status and CDSCO class of each before filing, to ensure the MD15 license covers the full intended import portfolio from the date of grant.
Why are hydraulic male urinary incontinence treatment systems classified as Class C rather than Class B?
Hydraulic male urinary incontinence treatment systems — including the device itself and its individual components such as the port, tubing, and tubing plug — are classified as Class C because they are surgically implanted devices that perform a mechanical function (controlling urinary outflow) through a hydraulic mechanism within the body. They interface with urethral and periurethral tissues on a long-term basis, and their failure or malfunction directly affects urinary function and patient quality of life. This combination of surgical implantation, sustained internal contact, and critical functional role places them firmly in the moderate-to-high risk Class C tier rather than the Class B tier applicable to external or non-implanted urological instruments.
Can a manufacturer of Class A wearable urological devices add a Class B cystoscope to their existing MD5 license, or does this require a new application?
Adding a new device to an existing MD5 license requires a license amendment application through the CDSCO SUGAM portal, not a fresh license application. The amendment application must declare the new device, provide the applicable per-device fee (Rs. 500 for each additional Class B device), and submit any additional documentation specific to the new device — particularly a Device Master File covering the cystoscope's design, performance testing, and sterility data if it is a sterile device. Rego Services manages license amendment applications on behalf of clients expanding their licensed urological device portfolios.
Are laser lithotripsy systems and their fibres / suction guides licensed together or separately?
A laser lithotripsy system and its dedicated laser lithotripsy fibre/suction guide are separately notified Class C urological devices under CDSCO's schedule. If a manufacturer produces or imports both — the laser lithotripsy system and the dedicated fibre/suction guide used with it — each must be separately declared in the MD9 or MD15 application, with the applicable per-device fee paid for each. Manufacturers and importers who supply the complete lithotripsy system including accessories in a single commercial offering should confirm the notified status of each individual component to ensure their license covers every element of the product they intend to place on the Indian market.
What is the significance of the "reusable" designation in Class B urological device classification?
CDSCO's urological device schedule distinguishes between single-use and reusable versions of several Class B urological instruments — flexible video cystoscopes, stone retrieval baskets, and fibreoptic ureteroscopes, among others. The "reusable" designation indicates that the specific device is designed, validated, and labelled for reprocessing and multiple uses across patients, which carries implications for the device's cleaning, disinfection, and sterilisation validation documentation within the Device Master File. Manufacturers and importers must ensure that the reusable versus single-use designation in their license application precisely matches the intended use and labelling of the specific device, since a misclassified designation can generate reviewer queries or, more seriously, lead to a license that does not accurately reflect the device's actual intended use.
✓ Key Takeaways
- India's urological device market is projected to reach approximately USD 600 million by 2029 at ~9% CAGR — driven by kidney stones, BPH, urinary incontinence, and urological cancer incidence across a large and ageing population
- Urological devices span all four CDSCO risk classes — from wearable urine collection bags and incontinence liners (Class A) through cystoscopes and stone retrieval baskets (Class B), laser lithotripsy systems and hydraulic incontinence treatment systems (Class C), to implantable sacral nerve stimulators and artificial urinary sphincters (Class D)
- Three license types apply: MD5 (manufacture Class A/B — State Licensing Authority, Rs. 5,000 + Rs. 500/device), MD9 (manufacture Class C/D — CDSCO Central, Rs. 50,000 + Rs. 1,000/device), and MD15 (import all classes — CDSCO Central)
- All three license types are valid indefinitely — but the retention fee must be paid every 5 years, or the license is automatically cancelled with no grace period or reinstatement mechanism
- ISO 13485 certification and a comprehensive Device Master File — with particular emphasis on ISO 10993 biocompatibility data for devices in urinary tract contact and ISO 14971 risk management for implantable devices — are mandatory for all manufacturing license applications
- The CDSCO application process follows 5 structured steps: document preparation, SUGAM portal submission, query resolution, facility inspection (for manufacturing licenses), and license approval
- First-time manufacturers requiring initial batch Certificate of Analysis data will need an MD13 test license before applying for the permanent MD5 or MD9 license
- The reusable vs single-use designation in CDSCO's urological device schedule carries regulatory significance — the Device Master File must include reprocessing validation for reusable devices, and the license application must precisely reflect the intended use and labelling of the specific product
Your Next Step
India's urology device market combines one of the world's largest underlying disease burdens with a rapidly expanding specialist care infrastructure and strong structural growth drivers — making it one of the more commercially compelling segments within the country's broader medical device landscape. For manufacturers and importers entering this segment, securing the correct CDSCO license is both the legal prerequisite for market participation and the foundation of the commercial credibility that hospital procurement teams and specialist urologists require from their device suppliers.
Rego Services' regulatory team brings comprehensive experience with CDSCO's requirements across the full spectrum of urological devices — from Class A wearable urological accessories through Class B diagnostic cystoscopes and stone retrieval systems, Class C laser lithotripsy equipment and implantable incontinence treatment systems, to Class D sacral nerve stimulators and artificial urinary sphincters. With our support, the path from device classification through ISO 13485 certification, Device Master File and Plant Master File preparation, SUGAM portal submission, query resolution, and license grant becomes a structured, managed process rather than the complex undertaking it can be without specialist regulatory guidance.
Contact Rego Services today to discuss your CDSCO urological medical device license requirements and receive a device-specific regulatory plan with a realistic timeline for your India market entry.