CDSCO License for Kidney stone filter

Comprehensive Guide to CDSCO Licensing for Kidney Stone Filter (Class C Medical Device)

The kidney stone filter is a critical medical device designed for nephrology and renal care. Intended to be placed in the urinary duct, it prevents renal stones from migrating from the kidney into the bladder, reducing complications and improving patient outcomes. Given its invasive nature and the risk profile, this device falls under Class C as per the CDSCO classification system, requiring rigorous regulatory compliance before it can be manufactured or imported in India.

CDSCO Regulatory Framework for Kidney Stone Filter

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India, ensuring safety, efficacy, and quality. For the kidney stone filter, which is a Class C device, regulatory oversight is stringent. The device is notified under Notification 29/Misc./03/2020-DC (143) dated 13.9.2021, mandating compliance with the Medical Device Rules (MDR) 2017.

Manufacturers and importers must obtain the appropriate licenses from CDSCO—the Central Licensing Authority—to legally market this device.

Risk Classification and License Requirements for Kidney Stone Filter

Class C devices, like the kidney stone filter, represent moderate to high risk. They require a Manufacturing License (MD9) for domestic production and an Import License (MD15) for import. Both licenses are issued by the Central Licensing Authority at CDSCO headquarters in New Delhi.

Understanding your device's classification is critical. For more about medical device classification, refer to our detailed Medical Device Classification guide.

Manufacturing License Process (MD9) for Kidney Stone Filter

The MD9 license process is comprehensive, taking approximately 4 to 5 months from start to finish. Here’s a step-by-step breakdown:

1. Test License (MD13): Before applying for the MD9, you must first obtain a test license to conduct product testing. This takes about 1.5 to 2 months.
2. Product Testing: Testing must be performed at CDSCO-recognized laboratories. Ensure your kidney stone filter is tested for biocompatibility, sterility, and mechanical integrity. Find approved labs on the CDSCO testing laboratories list.
3. Documentation Preparation: Prepare detailed technical documents, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
4. License Application Submission: Apply on the CDSCO MD Online Portal using Form MD7.
5. Audit and Inspection: CDSCO inspectors will conduct an on-site audit of your manufacturing facility and review compliance.
6. Query Resolution: Address any queries raised by CDSCO or auditors promptly.
7. Grant of License: Upon successful compliance, the MD9 license is granted.

Manufacturing License Documents Required for Kidney Stone Filter (Class C)

For a smooth application, ensure you have the following ready:

• Company Constitution Documents (Incorporation Certificate, MOA, AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• List and Qualification Certificates of Technical Staff
• Fire Safety NOC
• Pollution Control NOC
• Device Master File (detailed product specifications, design, manufacturing process)
• Plant Master File (facility layout, equipment, quality controls) – refer to our Plant Master File guide
• Essential Principles Checklist confirming compliance with MDR
• Risk Management File demonstrating hazard analysis and mitigation – see our Risk Management resource
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (ISO 13485:2016 certification is highly recommended)

Import License Process (MD15) for Kidney Stone Filter

If you're importing the kidney stone filter, the MD15 license is mandatory. The import license process typically spans 5 to 6 months and involves:

1. Document Preparation: Collect all required documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, and technical files.
2. Application Submission: Apply through the CDSCO MD Online Portal using Form MD14.
3. Query Resolution: Respond to any queries from CDSCO promptly.
4. License Issuance: Upon satisfactory review, the import license (Form MD15) is granted.

Import License Documents Required for Kidney Stone Filter

• Valid Manufacturing License from the country of origin
• Free Sale Certificate (FSC) verifying product marketability abroad
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution Documents

Timeline and Processing Duration

Government Fees and Costs

MD9 Manufacturing License (Class C)

• Application Fee: Rs. 50,000
• Per Product Fee: Rs. 1,000 per product

MD15 Import License

• Class C & D Fees: $3,000 per site +$1,500 per product

Note: Fees are subject to periodic revision by CDSCO. Budgeting for additional costs such as notified body audits and product testing is essential.

Common Challenges and Solutions When Obtaining CDSCO License for Kidney Stone Filter

• Incomplete Documentation: Missing or inconsistent documents cause delays. Use checklists to verify completeness.
• Delayed Product Testing: Choose from CDSCO-recognized labs early and book testing slots in advance.
• Audit Non-Compliance: Prepare your plant and QMS thoroughly. Engage with notified bodies listed here for smooth audits.
• Query Resolution Delays: Assign a dedicated regulatory expert to monitor and respond to CDSCO queries promptly.

Expert Consultation and Support

With over 25 years of experience and having assisted 500+ companies, we understand the intricacies of CDSCO licensing. Our expert team guides you through:

• Tailored documentation preparation
• Liaison with CDSCO and notified bodies
• Product testing coordination
• Audit readiness and compliance
• Timely application submission through the CDSCO MD Online Portal

Getting Started with Your CDSCO License Application for Kidney Stone Filter

1. Determine License Type: For manufacturing, prepare for MD9; for import, prepare MD15.
2. Gather Initial Documents: Start with company constitution, premises proof, and technical staff details.
3. Initiate Test License (for manufacturing): Apply early for the MD13 test license.
4. Select Testing Laboratory: Identify and schedule testing at CDSCO-approved labs.
5. Develop Technical Files: Prepare Device and Plant Master Files along with Risk Management documentation.
6. Register on CDSCO Portal: Create your user account and submit your applications online.
7. Plan for Audit: Ensure your manufacturing facility complies with all QMS and MDR requirements.

By following these practical steps and leveraging professional support, your kidney stone filter can successfully navigate the CDSCO regulatory pathway, enabling you to access the Indian medical device market with confidence.

For detailed guides on license application forms and processes, visit our MD9 License Guide and Import License Guide.

Embark on your regulatory journey today and ensure compliance with India's evolving medical device landscape.