CDSCO License for RETRIEVAL SNARE

Comprehensive Guide to CDSCO Licensing for Retrieval Snare Medical Devices (Class D)

Retrieval Snare devices are critical medical tools used for the atraumatic retrieval and manipulation of foreign bodies within coronary, peripheral, and extracranial neurovascular systems. As high-risk Class D devices, they require thorough regulatory compliance overseen by the Central Drugs Standard Control Organization (CDSCO) in India. Navigating this complex regulatory landscape demands expert knowledge and precise documentation to ensure timely market access.

With over 25 years of experience and having supported 500+ medical device companies, we provide you with a detailed, step-by-step guide to obtaining your CDSCO MD9 manufacturing or import license for Retrieval Snare devices.

CDSCO Regulatory Framework for Retrieval Snare (Class D Catheters)

The CDSCO regulates medical devices according to risk classification. Retrieval Snares, categorized under catheters and notified under Notification 29/Misc/3/2017-DC (292) dated 06.06.2018, fall into the highest risk Class D. This classification mandates Central Licensing Authority oversight, rigorous testing, and comprehensive audits.

Compliance is governed by the Medical Device Rules 2017, requiring manufacturers and importers to secure the MD9 manufacturing license or MD15 import license respectively before market entry.

For detailed device classification, refer to the Medical Device Classification guide.

Risk Classification and License Requirements for Retrieval Snare

• Risk Class: D (highest risk)
• Regulatory Authority: Central Licensing Authority, CDSCO
• Licensing Form: MD9 (Application Form MD7)
• Process Duration: Approximately 4-5 months
• Cost: ₹50,000 per application + ₹1,000 per product

This classification requires adherence to stringent quality management systems (QMS), clinical evaluations, risk management, and product testing by government-approved laboratories.

Manufacturing License Process (MD9) for Retrieval Snare

Step 1: Obtain Test License (Form MD13)

Before applying for the MD9 license, manufacturers must secure a test license (MD13), which takes around 1.5 to 2 months. This license allows you to legally manufacture prototype devices for testing purposes.

Step 2: Product Testing

Products are tested in government-recognized labs to verify compliance with Indian and international standards. Access the list of Testing Laboratories approved by CDSCO.

Step 3: Document Preparation

Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Evidence of QMS implementation. Our Device Master File guide and Plant Master File guide can assist in this critical phase.

Step 4: Submit Application (Form MD7)

Submit your MD9 license application through the CDSCO MD Online Portal with all required documents.

Step 5: CDSCO Audit and Inspection

Post submission, CDSCO inspectors conduct a detailed audit of your manufacturing facility, quality systems, and documentation.

Step 6: Query Resolution

Respond promptly to queries raised by CDSCO or auditors to avoid delays.

Step 7: Grant of MD9 License

Upon satisfactory inspection and documentation review, CDSCO grants the MD9 manufacturing license on Form MD9.

For a comprehensive overview, consult our MD9 License Guide.

Manufacturing License Documents Required for Retrieval Snare

Prepare the following mandatory documents to ensure a smooth approval process:

• Certificate of Incorporation and Company Constitution
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing device design, manufacturing process, and validations
• Plant Master File (PMF) describing infrastructure and facilities
• Essential Principles Checklist confirming compliance with Medical Device Rules
• Risk Management File adhering to ISO 14971 principles (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU) compliant with CDSCO requirements
• Quality Management System documentation (ISO 13485:2016 certified)

Import License Process (MD15) for Retrieval Snare

For importers, the process is centralized and involves:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016 certificate, Device Master File, and Plant Master File
• Submission of application Form MD14 via the CDSCO MD Online Portal
• Departmental review and query resolution
• Grant of Import License (MD15)

The typical timeline is 5-6 months without the need for a test license.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• CE Certificate (if applicable)
• ISO 13485:2016 Certification
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Details

Government fees vary by device class:

• Class D devices: ₹3,00,000 per site + ₹1,50,000 per product

Refer to our detailed Import License Guide for tailored assistance.

Timeline and Processing Duration

Total Estimated Time: 4-5 months for MD9 license

For imports via MD15, expect 5-6 months.

Government Fees and Costs

• MD9 License: ₹50,000 per application + ₹1,000 per product
• Test License (MD13): Included in overall process fees
• Import License (MD15): ₹3,00,000 per site + ₹1,50,000 per product for Class D devices

Additional costs may include notified body audit fees and testing lab charges.

Common Challenges and Solutions

• Challenge: Delays in product testing due to lab backlogs

  • Solution: Pre-book testing slots with CDSCO-approved labs early; check the latest Testing Laboratories list.

• Challenge: Incomplete or inconsistent documentation

  • Solution: Use standardized templates for Device and Plant Master Files and risk management documentation. Refer to our master file guides.

• Challenge: Audit non-compliance due to facility gaps

  • Solution: Conduct mock audits and gap assessments before CDSCO inspections.

• Challenge: Slow response to CDSCO queries

  • Solution: Maintain a dedicated regulatory affairs team for timely communication.

Expert Consultation and Support

Navigating the CDSCO regulatory maze for high-risk devices like Retrieval Snares requires specialist expertise. Our team offers:

• End-to-end regulatory strategy
• Documentation preparation and review
• Liaison with CDSCO and notified bodies
• Mock audits and compliance training
• Post-license market surveillance advice

Partnering with experienced consultants can reduce approval times and prevent costly rejections.

Getting Started with Your CDSCO License Application for Retrieval Snare

1. Assess Classification: Confirm your Retrieval Snare is Class D per CDSCO notification.
2. Prepare Documentation: Begin compiling your Device Master File, Plant Master File, QMS records, and risk management documents.
3. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal to legally start prototype manufacturing.
4. Schedule Product Testing: Coordinate with government-approved labs early to avoid delays.
5. Organize Facility Audit: Prepare for notified body audit by reviewing compliance checklists and conducting internal assessments.
6. Submit MD9 Application: Complete Form MD7 with all requisite attachments via the online portal.
7. Engage Proactively: Monitor application status, promptly address queries, and maintain open communication with CDSCO.

By following this practical roadmap and leveraging our extensive experience, manufacturers and importers of Retrieval Snare devices can confidently navigate CDSCO licensing requirements and successfully enter the Indian market.

For personalized assistance, consult our detailed MD9 License Guide.

Navigating the regulatory requirements for high-risk medical devices need not be daunting. With informed planning and expert support, your Retrieval Snare device can achieve timely CDSCO approval, ensuring safe, compliant access to the Indian healthcare market.