The field of urology deals with male and female urinary tract-related diseases. The primary focus is the functioning and disorder of kidneys, ureters, bladder, and urethra. Additionally, disorders of the male organs, such as penis, testes, scrotum, prostate, etc., also fall under the purview of urology. A doctor who specializes in treating urological disorders is known as a urologist. Notably, urology is among the fastest growing specialities, with high demand for urologists. Moreover, urologists use a wide range of specialized equipment and medical devices. Hence, medical devices for urology are in high demand. Thus, the quality, efficacy, and safety of urological medical devices are strictly regulated by the CDSCO. Therefore, securing the CDSCO urological medical device license is mandatory. In this blog, we have curated a detailed guide on how to secure the CDSCO medical device license for urological devices. 

Urologists require certain specialized medical devices that are designed specifically for the field of urology. Urine collection bags, urine drainage catheters, foley balloon catheters, and irrigation sets are some of the commonly used urological medical devices. Additionally, specialized diagnostic and therapeutic imaging medical devices are required. Furthermore, urological examination chair or table is a mandatory requirement for any urology clinic. Moreover, surgical instruments, such as forceps, urethral sounds, scissors, catheter introducers, and surgical sutures, are also required. Given the role of medical devices in urology, they have to be stringently regulated. Thus, urological medical device manufacturers and importers are required to strictly abide by CDSCO regulations. CDSCO aims to ensure high-quality, safe, and effective medical devices reach the Indian healthcare industry.

Indian urological medical device market trends

The Indian urology market size is expected to touch approximately USD 599.81 million by 2029. Notably, it is expected to grow at a CAGR of 9.03% during the 2024 to 2029 period.

The Indian urological medical device market can be divided into the following segments:

• Product type: Stone management devices, benign prostate hyperplasia treatment devices, erectile dysfunction treatment devices, and urinary incontinence devices
• End users: Government hospitals, private hospitals, and urology clinics

The Indian urological medical device market is being driven by various factors. First, the rise in incidence of urological diseases and increase in health awareness. Second, increase in number of specialized urological medical facilities and clinics. Third, technological advancements of urological medical devices. Moreover, the government has introduced various schemes to promote domestic medical device production. Furthermore, it is trying to simplify the CDSCO urological medical device license application process to help medical device companies. Finally, India is witnessing a rise in healthcare expenditure and investment in health insurance schemes.

CDSCO urological medical device license application

Securing the CDSCO urological medical device license is mandatory to launch your devices in India. To manufacture urological devices in India, you have to secure the CDSCO medical device manufacturing license. On the other hand, to import urological devices into India, you have to secure the CDSCO medical device import license. To secure these licenses, you have to abide by the CDSCO regulatory guidelines. Furthermore, an understanding of the CDSCO medical device classification system is required to proceed with the CDSCO license application process. This is because the CDSCO class will determine the next steps in the license application process.

Understanding the CDSCO urological medical device classification system

Based on the risk level associated with their intended use, the CDSCO has classified medical devices into four classes, A, B, C, and D. This CDSCO medical device classification system has been formulated to simplify the medical device license application process. Specific application processes and licenses are applicable for specific CDSCO medical device classes. Hence, an understanding of the CDSCO medical device classification system is required for the medical device license application process.

CDSCO urological medical device classes

To give you a basic idea, we have listed few examples of urological devices belonging to the different CDSCO classes. To check which class your medical device belongs to, you can use our free tool.

CDSCO class A

• 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
• Home faecal specimen collection kit
• Incontinence device suspender
• Incontinence pants liner
• Incontinence pants, reusable
• Incontinence penis clamp, reusable

Class B

• Biliary/urinary stone retrieval basket, reusable
• Bladder-emptying vibratory stimulator
• Cystometer
• Cystometer probe, ultrasonic
• Cystoscopic electrode
• Electrohydraulic lithotripsy system
• Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use
• Electromechanical lithotripsy system, intracorporeal
• Fibreoptic ureteral catheter, reusable
• Filiform urethral bougie
• Flexible endoscopic stone-retrieval forceps, reusable
• Flexible fibreoptic cystonephroscope
• Flexible fibreoptic cystoscope
• Flexible fibreoptic cystourethroscope
• Flexible fibreoptic nephroscope
• Flexible fibreoptic ureterorenoscope
• Flexible fibreoptic ureteroscope
• Flexible fibreoptic urethroscope
• Flexible ureteral sheath/fibreoptic telescope
• Flexible video cystonephroscope
• Flexible video cystoscope, reusable
• Flexible video cystourethroscope
• Flexible video nephroscope
• Flexible video ureterorenoscope, reusable
• Flexible video ureteroscope, reusable
• Flexible video urethroscope
• General-purpose ureteral catheter
• Hand pneumatic lithotripsy system, urinary
• Hepatic function analysis system
• Incontinence sensor/alarm

CDSCO class C

• 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

CDSCO urological medical devices license types

• Importing urological devices into India: MD 15 Import License has to be secured from the CDSCO to import urological devices into India.
• Manufacturing class A and B urological devices: MD 5 License will be required to manufacture class A and B urological devices. Moreover, a fee of Rs. 5,000 for the manufacturing license is required. Additionally, Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
• Manufacturing class C and D urological devices: MD 9 License  will be required to manufacture class C and D urological devices. Moreover, a fee of Rs. 50,000 for the manufacturing license is required. Additionally, Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.

Documents required for securing the CDSCO urological medical device license

We have listed the documents required to apply for the CDSCO urological medical device license.

1. Device Master File
2. Plant Master File
3. Organization identity proof
4. Sale Deed/Rent Deed of the Premises
5. Building Layout with Dimension
6. Documents for the team of qualified and experienced staff who can manufacture and test your medical devices.
7. Environmental regulation compliance documents
8. Certificate of analysis of 3 consecutive batches
9. ISO 13485 Certificate
10. Test License, if required for testing the urological medical device

We have provided an overview of the documents required. For a detailed list of documents, feel free to contact us. Furthermore, our team of experts will help you prepare and compile the documents as per CDSCO guidelines. We have extensive expertise in CDSCO document preparation.

CDSCO urological medical devices license application process

The CDSCO license application process for urological devices involves the following steps:

• Check CDSCO Class: The first step while applying for CDSCO medical device license is to check which class your medical device belongs to.
• Document preparation: Compile all necessary documents, including clinical trial data and product specifications. All supporting documents have to be meticulously prepared.
• Application Submission: File the application online on CDSCO’s official online portal.
• Query Resolution: CDSCO may raise queries that have to be promptly and accurately addressed.
• Inspection: Prepare for the CDSCO medical device facility inspection and audit phase.
• License Approval: Once all the criteria are satisfied, CDSCO will grant the medical device license.

CDSCO urological medical devices license validity

The CDSCO urological medical devices license is valid indefinitely. However, the license retention fee has to be paid every 5 years; otherwise, the license will be cancelled automatically.

Pharmadocx Consultants: Your trusted ally

The CDSCO urological medical device license application process is an arduous and time-consuming process. With the help of the Pharmadocx Consultants team, you can have a smooth and efficient CDSCO regulatory journey. Call/Whatsapp on 9996859227 or drop an email at [email protected] to let us handle the CDSCO license application and regulatory hassles.