CDSCO License for Urethrographic  Male Catheter

Comprehensive Guide to CDSCO Licensing for Urethrographic Male Catheters (Class B)

Manufacturing or importing a Urethrographic Male Catheter in India demands a thorough understanding of the Central Drugs Standard Control Organization (CDSCO) regulatory landscape. This device, classified as Class B under the notified category of catheters (Notification 29/Misc/3/2017-DC (292), dated 06.06.2018), serves a critical purpose in urological procedures by facilitating bladder access. Given its medium risk classification, obtaining the appropriate CDSCO license is essential to ensure compliance, market access, and patient safety.

With over 25 years of regulatory consulting experience and support to 500+ companies, we distill this complex process into actionable steps tailored specifically for Urethrographic Male Catheters.

CDSCO Regulatory Framework for Urethrographic Male Catheters

The CDSCO governs all medical devices under the Medical Device Rules (MDR) 2017. Urethrographic Male Catheters fall under Class B, indicating moderate risk requiring state-level licensing.

This regulatory framework ensures that devices meet quality, safety, and efficacy standards before commercial distribution. Compliance involves multiple stages, including testing, documentation, audits, and licensing.

You can initiate and track your application by submitting documents through the CDSCO MD Online Portal.

Risk Classification and License Requirements

Medical devices in India are classified into four risk categories:

• Class A (Low risk)
• Class B (Low-moderate risk)
• Class C (Moderate-high risk)
• Class D (High risk)

Urethrographic Male Catheters are Class B devices, requiring an MD5 manufacturing license granted by the State Licensing Authority.

License Type for Class B Device:

• Manufacturing License: MD5 License (Application Form MD3)
• Authority: State Licensing Authority
• Typical Timeline: 3-4 months
• Government Fees: INR 5,000 per application + INR 500 per product

Understanding this classification helps in selecting the correct application form and preparing the relevant documents.

Manufacturing License Process for Urethrographic Male Catheters (MD5)

The journey to obtaining an MD5 license for manufacturing a Class B device involves several well-defined steps:

1. Test License Application (Form MD13): Before full license application, a test license is mandatory. This allows you to manufacture limited quantities for laboratory testing.

2. Product Testing: The catheter must be tested in government-approved laboratories to validate compliance with Indian standards. Refer to the official list of Testing Laboratories.

3. Preparation of Technical Documentation: Device Master File, Plant Master File, Risk Management File, and other technical documents must be compiled.

4. Application Submission (Form MD3): Submit the full manufacturing license application along with supporting documents via the CDSCO MD Online Portal.

5. Audit by Notified Body: An on-site audit by a notified body is required to verify compliance. Check the Notified Bodies List for authorized auditors.

6. Query Resolution: Address any queries raised by the licensing authority or auditors promptly to avoid delays.

7. License Grant: Upon successful audit and documentation review, the MD5 license will be granted.

Practical Tip:

Plan the test license and laboratory testing well in advance as these steps typically consume 1.5 to 2 months.

Manufacturing License Documents Required for Urethrographic Male Catheter

Accurate and complete documentation is pivotal. Below is a detailed checklist:

• Company Constitution Documents (e.g., Certificate of Incorporation, Partnership Deed)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device description, manufacturing process, and quality control measures. For guidance, see our Device Master File Guide.
• Plant Master File (PMF): Description of manufacturing facility, equipment, and quality systems. Learn more at our Plant Master File Guide.
• Essential Principles Checklist to demonstrate compliance with Indian MDR
• Risk Management File demonstrating hazard analysis and mitigation strategies. Refer to our Risk Management Resource.
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU) complying with regulatory standards
• Quality Management System (QMS) documentation, preferably ISO 13485-certified

Import License Process for Urethrographic Male Catheters (MD15)

If you intend to import this device, an MD15 import license from the Central Licensing Authority is mandatory.

Key Steps:

1. Document Preparation: Compile manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution.

2. Application Submission (Form MD14): Submit through the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any clarifications.

4. License Grant: The MD15 license will be issued typically within 5-6 months.

Import License Fees for Class B Device:

• INR 2000 per site
• INR 1000 per product

Timeline and Processing Duration

Overall, expect approximately 4.5 to 6 months from initiating the test license to receiving the manufacturing license.

Government Fees and Costs

• Test License (MD13): No separate fee; included in application.
• MD5 License: INR 5000 per application + INR 500 per product
• Notified Body Audit: Varies, typically INR 50,000 - 100,000 depending on auditor.
• Testing Fees: Approximately INR 30,000 - 60,000 per product depending on test scope.

Budgeting for these costs upfront helps avoid surprises and plan your market entry strategy effectively.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or inadequate test reports.

Solution: Engage experienced regulatory consultants to prepare thorough documentation and select accredited labs for testing.

Challenge: Audit non-compliance findings leading to repeated visits.

Solution: Conduct internal audits and gap analyses before notified body visits.

Challenge: Prolonged query resolution timelines.

Solution: Assign dedicated personnel to monitor application status and respond promptly to CDSCO queries.

Expert Consultation and Support

Navigating the CDSCO licensing maze for Urethrographic Male Catheters can be daunting. Our team has successfully assisted 500+ organizations in securing timely approvals by offering:

• End-to-end regulatory strategy and documentation support
• Coordination with notified bodies and testing laboratories
• Pre-audit readiness assessment
• Tailored training on compliance and quality systems

Partnering with seasoned experts mitigates risks and accelerates your product launch.

Getting Started with Your CDSCO License Application for Urethrographic Male Catheters

1. Assess Your Device Classification: Confirm your device's Class B status using resources like the Medical Device Classification guide.

2. Prepare Test License Application: Gather preliminary documents and apply for the test license via the CDSCO MD Online Portal.

3. Select Accredited Testing Laboratory: Choose from the CDSCO-approved list to perform product testing.

4. Compile Essential Documentation: Utilize our Device and Plant Master File guides to streamline preparation.

5. Schedule Notified Body Audit: Coordinate with an authorized body early to minimize waiting times.

6. Submit Manufacturing License Application (Form MD3): Upload your complete application online and track progress.

7. Prepare for Queries and Audit: Maintain readiness to address any deficiencies promptly.

Starting early and leveraging expert support ensures a smoother journey to obtaining your MD5 manufacturing license, enabling you to deliver the Urethrographic Male Catheter safely and compliantly to the Indian market.

For detailed assistance, contact our regulatory team to tailor a compliance roadmap designed for your unique product and business model.