CDSCO License for Double lumen Female Urethrographic Catheter

Introduction to Double Lumen Female Urethrographic Catheter and Regulatory Importance

The Double lumen Female Urethrographic Catheter is a specialized vascular access device used for infusion and withdrawal of blood, blood products, and fluids. It plays a crucial role in procedures such as plasma pheresis, hyperalimentation, central venous blood sampling, and continuous or intermittent drug infusion. Given its invasive nature and critical applications, this catheter is classified as a Class B medical device under the Indian regulatory framework.

Navigating the regulatory landscape for such a device is essential for manufacturers and importers aiming to enter the Indian market legally and efficiently. Compliance with Central Drugs Standard Control Organization (CDSCO) regulations ensures patient safety, product quality, and market acceptance.

CDSCO Regulatory Framework for Double Lumen Female Urethrographic Catheters

The CDSCO regulates medical devices through a risk-based classification system. For Class B devices like the Double lumen Female Urethrographic Catheter, the licensing falls under the State Licensing Authorities, requiring an MD5 manufacturing license. The regulatory pathway includes obtaining a test license, product testing at government-approved laboratories, document submission, and audit by a notified body.

This framework is designed to maintain high safety standards while facilitating timely access to the market. Our extensive experience helping over 500 companies navigate this process makes us a trusted partner in your regulatory journey.

Risk Classification and License Requirements for Class B Catheters

According to the Medical Device Classification guidelines, Class B devices represent low to moderate risk. For these devices, the MD5 manufacturing license is mandatory. This license involves detailed scrutiny of technical and quality management documents, ensuring that the device meets essential safety and performance criteria.

Specifically, for the Double lumen Female Urethrographic Catheter (Notification 29/Misc/3/2017-DC (292), dated 06.06.2018), compliance with the MD5 license framework is required before commencing manufacturing or marketing in India.

Manufacturing License Process (MD5) for Double Lumen Female Urethrographic Catheter

The MD5 license process involves several sequential steps:

1. Apply for Test License (Form MD13): This initial step allows the manufacturer to produce limited quantities for testing purposes. It typically takes 1.5 to 2 months.

2. Product Testing: Samples must be tested at government-approved laboratories to verify compliance with Indian standards. A list of Testing Laboratories is available on the CDSCO portal.

3. Document Preparation: Compile comprehensive technical documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Submit MD5 License Application (Form MD3): Application is submitted through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts an on-site audit of manufacturing facilities and quality systems. Refer to the list of notified bodies for audit selection.

6. Resolve Queries: Address any queries raised by the CDSCO or notified body promptly.

7. Grant of License: Upon successful completion of all steps, the MD5 license is granted.

Manufacturing License Documents Required

For the Double lumen Female Urethrographic Catheter, the following documents are critical:

• Company Constitution Documents: Certificate of incorporation, Memorandum and Articles of Association.
• Proof of Ownership or Lease of Manufacturing Premises: Rental agreements or ownership deeds.
• Technical Staff Details: Qualification and experience certificates of key personnel.
• Fire and Pollution NOCs: Obtained from local authorities.
• Device Master File (DMF): Detailed device design, specifications, and manufacturing process. Our Device Master File Guide offers practical insights.
• Plant Master File (PMF): Facility layout, equipment details, and quality control measures. Learn more from our Plant Master File Guide.
• Essential Principles Checklist: Compliance checklist based on Indian standards.
• Risk Management File: Documented risk analysis and mitigation strategies following international best practices. See our Risk Management guide.
• Product Test Reports: From government-approved labs.
• Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related procedures.

Import License Process (MD15) for Double Lumen Female Urethrographic Catheter

If you are an importer intending to bring this Class B catheter into India, an MD15 import license is mandatory. This license is granted by the Central Licensing Authority.

The steps include:

1. Document Compilation: Prepare documents such as Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, Wholesale license, and Company Constitution.

2. Application Submission: Submit application on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution: Respond to any clarification requests.

4. License Grant: Typically takes 5-6 months.

Refer to our detailed Import License Guide to streamline this process.

Import License Documents Required

Key documents for MD15 import license include:

• Manufacturer’s MD5 or MD9 Manufacturing License.
• Free Sale Certificate from the country of origin.
• ISO 13485:2016 certificate.
• CE Certificate or equivalent international certification.
• Device Master File and Plant Master File.
• Wholesale drug license for the importer.
• Company Constitution documents.

Timeline and Processing Duration for Class B Catheters

Overall, manufacturers should anticipate around 4-6 months to obtain full marketing authorization for the Double lumen Female Urethrographic Catheter.

Government Fees and Costs

For the MD5 manufacturing license relevant to Class B devices:

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs include fees for testing at approved laboratories and notified body audits.

For import licenses (MD15), fees vary based on device class; for Class B devices, costs are approximately $2,000 per site and$1,000 per product.

Common Challenges and Solutions in CDSCO Licensing

• Incomplete Documentation: Many applicants face delays due to missing or poorly prepared documents. We advise thorough checklist-based preparation.

• Testing Delays: Scheduling product testing at government labs can be time-consuming. Early booking and following up with labs mitigate this risk.

• Audit Readiness: Non-compliance during notified body audits causes rejections. Conduct internal pre-audits and staff training.

• Query Management: Prompt and clear responses to CDSCO queries accelerate approvals.

Our practical experience allows us to anticipate and resolve these pain points effectively.

Expert Consultation and Support

With over 25 years of experience and assisting 500+ companies, we provide end-to-end support for:

• Device classification and regulatory strategy
• Document preparation including DMF, PMF, and Risk Management Files
• Coordination with notified bodies and testing labs
• Application submission and follow-up
• Training and audit preparedness

Our expert team stays updated with the latest CDSCO notifications and guidelines to ensure your compliance.

Getting Started with Your CDSCO License Application for Double Lumen Female Urethrographic Catheter

1. Classify Your Device: Confirm your device’s Class B status using the Medical Device Classification resources.

2. Prepare Documentation: Begin compiling your Device Master File and Plant Master File using our comprehensive guides.

3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.

4. Schedule Testing: Engage with government-approved laboratories early.

5. Plan for Audit: Identify a suitable notified body from the Notified Bodies List and prepare your facility.

6. Submit MD5 Application: After testing and audit, submit Form MD3 through the portal.

7. Engage Expert Support: Consider partnering with regulatory consultants to ensure smooth navigation of the process.

Taking these informed, actionable steps will position your Double lumen Female Urethrographic Catheter for successful market entry in India. For personalized assistance, reach out to our regulatory experts who have a proven track record of success in CDSCO licensing.