CDSCO License for Intermittent urethral drainage catheter, non- sterile

Introduction to Intermittent Urethral Drainage Catheters and Regulatory Importance

Intermittent urethral drainage catheters, non-sterile, are vital urology devices designed for individuals unable to void urine naturally. These flexible or rigid tubes are self-applied to provide short-term urine drainage, improving patient autonomy and quality of life. Given their direct interaction with the urinary tract, regulatory oversight ensures safety, quality, and performance.

In India, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or importing such devices. Navigating CDSCO’s licensing process can be complex, especially for Class B medical devices like intermittent urethral drainage catheters. With over 25 years of experience and having assisted 500+ companies secure CDSCO licenses, we break down the entire process to help manufacturers and importers enter the Indian market smoothly.

CDSCO Regulatory Framework for Intermittent Urethral Drainage Catheters

The CDSCO categorizes medical devices based on risk and intended use. Intermittent urethral drainage catheters fall under the urology category and are classified as Class B medical devices per the notification [File No. 29/Misc./03/2020-DC (145)] dated 23.08.2021.

Class B devices pose low to moderate risk and require a manufacturing license (MD5) from the State Licensing Authority. These devices must comply with Indian Medical Device Rules (IMDR) 2017 and related amendments. For importers, the Import License (MD15) from the Central Licensing Authority is mandatory.

Risk Classification and License Requirements for Class B Devices

• Risk Class: B (Low to moderate risk)
• Manufacturing License Required: MD5 License (Application Form MD3)
• Issuing Authority: State Licensing Authority
• Import License Required: MD15 License (Application Form MD14)
• Issuing Authority for Import: Central Licensing Authority

The MD5 license process involves obtaining a test license (MD13), product testing by government-approved labs, audit by notified bodies, and compliance with quality management systems.

Manufacturing License Process for Intermittent Urethral Drainage Catheters (MD5)

The MD5 manufacturing license is a multi-step process:

1. Apply for Test License (Form MD13): This preliminary license allows sample testing and takes approximately 1.5 to 2 months to process.
2. Product Testing: Samples must be tested at CDSCO-approved labs. You can find the list of testing laboratories authorized for this purpose.
3. Document Preparation: Compile all required documents, including Device Master File (DMF), Plant Master File (PMF), QMS documents, risk management files, and labels.
4. Submit Application (Form MD3) for MD5 License: Applied through the CDSCO MD Online Portal.
5. Audit by a Notified Body: Conducted to verify manufacturing premises and quality systems. Refer to the list of notified bodies for audit services.
6. Resolve Queries: Address any issues raised during audit or by the regulatory authority.
7. License Grant: Issued on Form MD5 after successful compliance.

The entire process typically spans 3 to 4 months from test license application to final license issuance.

Manufacturing License Documents Required

For your intermittent urethral drainage catheter, you need to submit the following:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, manufacturing process, and validation. Our comprehensive Device Master File guide can assist in preparation.
• Plant Master File (PMF): Description of manufacturing facilities and quality control measures. Learn to prepare one with our Plant Master File Guide.
• Essential Principles Checklist
• Risk Management File detailing hazard analysis and mitigation measures. Refer to our Risk Management resource for best practices.
• Test Reports from Government-Approved Laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification documents

Ensure all documents are current, accurate, and compliant with CDSCO standards to avoid delays.

Import License Process for Intermittent Urethral Drainage Catheters (MD15)

For importers, the MD15 license is mandatory to legally bring the device into India. The process includes:

1. Document Preparation: Gather all required documents such as manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, DMF, PMF, wholesale license, and company constitution.
2. Submit Application (Form MD14): Applied through the CDSCO MD Online Portal.
3. Queries Resolution: Address any clarifications requested by CDSCO.
4. License Grant: Issued on Form MD15.

Unlike manufacturing, no test license is needed for import. The total timeline is approximately 5 to 6 months.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate from Regulatory Authority of Exporting Country
• ISO 13485:2016 Certificate
• CE Certificate or Equivalent
• Device Master File (DMF)
• Plant Master File (PMF)
• Wholesale License for Distribution in India
• Company Constitution and Incorporation Documents

Adhering strictly to document requirements and ensuring authenticity reduces the risk of rejection.

Timeline and Processing Duration

Plan your regulatory submissions accordingly to align with your product launch timelines.

Government Fees and Costs

• MD5 License: Rs 5000 per application + Rs 500 per product
• MD13 Test License: Included in MD5 process fees
• MD15 Import License: Fees vary by device class; for Class B devices, expect approximately Rs 2000 per site + Rs 1000 per product

Additional costs include testing laboratory fees, notified body audit charges, and consultancy fees if applicable. Budgeting for these upfront avoids unexpected expenses.

Common Challenges and Solutions

• Delays in Test Reports: Selecting an accredited and responsive testing lab is critical. Use the official Testing Laboratories list to select suitable labs.
• Incomplete Documentation: Use detailed checklists and expert reviews to ensure all documents meet CDSCO standards.
• Audit Non-Compliance: Prepare rigorously for notified body audits by implementing a robust QMS and conducting internal pre-audits.
• Query Resolution Delays: Respond promptly and thoroughly to regulatory queries. Maintain open communication channels.

Our experience shows that proactive planning and expert support significantly reduce these hurdles.

Expert Consultation and Support

Navigating CDSCO licensing requires specialized knowledge of regulations, documentation, and audit processes. With over 25 years of hands-on experience and having supported 500+ companies, we provide tailored consultancy that covers:

• Detailed gap analysis for your device and facility
• End-to-end document preparation assistance
• Liaising with notified bodies and testing labs
• Audit readiness training
• Query management and regulatory liaison

Our goal is to streamline your CDSCO license acquisition, minimizing delays and maximizing compliance.

Getting Started with Your CDSCO License Application

Here’s how to initiate your regulatory journey for the intermittent urethral drainage catheter:

1. Assess Device Classification: Confirm your device’s Class B status using the Medical Device Classification guide.
2. Preliminary Documentation: Begin compiling your Device Master File, Plant Master File, and risk management documentation.
3. Identify Testing Labs and Notified Bodies: Choose from CDSCO-approved options to ensure timely testing and audits.
4. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal to kickstart product testing.
5. Plan for Audit: Prepare your manufacturing site and quality systems in parallel.
6. Consult Experts: Engage with regulatory consultants to review your submissions and guide you through audit preparations.

By following these actionable steps and leveraging expert support, manufacturers and importers can confidently enter the Indian market with their intermittent urethral drainage catheters, ensuring compliance and patient safety.

For detailed guides on each license type, consider exploring resources such as our MD5 License Guide and Import License Guide.

Embark on your CDSCO licensing journey today with confidence and clarity.