CDSCO License for Intravascular Occluding Catheter

Introduction to Intravascular Occluding Catheters and Regulatory Importance

Intravascular Occluding Catheters are specialized medical devices designed to block blood vessels using an inflatable or detachable balloon tip, primarily used for treating vascular malformations such as intracranial aneurysms. Given their critical application in neurovascular interventions and associated high risk due to their invasive nature, these catheters fall under Class D medical devices as per CDSCO classification, which mandates stringent regulatory oversight.

Navigating the CDSCO (Central Drugs Standard Control Organization) licensing process for such high-risk devices is crucial for manufacturers and importers aiming to enter the Indian market. A thorough understanding of the regulatory framework, documentation, timelines, and costs can significantly streamline approvals and ensure compliance.

CDSCO Regulatory Framework for Intravascular Occluding Catheters

The CDSCO regulates medical devices in India under the Medical Device Rules 2017, with classification based on risk. Intravascular Occluding Catheters, categorized as Class D devices, require a central licensing authority approval due to their potential impact on patient safety.

The relevant notification governing this device is Notification No. 29/Misc/3/2017-DC (292), dated 06.06.2018, which lists catheters under regulated medical devices requiring mandatory registration and licensing.

Risk Classification and License Requirements

Class D devices like the Intravascular Occluding Catheter are considered high risk due to their invasive use and critical functions. This classification necessitates obtaining an MD9 Manufacturing License for domestic manufacturers or an MD15 Import License for importers.

• MD9 License: For manufacturing Class C and D devices, issued by the Central Licensing Authority (CDSCO HQ).
• MD15 License: For importing Class C and D devices, also issued by CDSCO HQ.

Both licenses require detailed documentation, stringent audits, and product testing to ensure safety and efficacy.

Manufacturing License Process (MD9) for Intravascular Occluding Catheter

The MD9 license application process is comprehensive and typically takes 4-5 months from start to finish. The key stages include:

1. Test License Application (Form MD13): Obtain a test license for the device, required before full manufacturing license application. This stage takes approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory product testing at CDSCO-approved government laboratories. Testing validates compliance with Indian standards and essential principles.
3. Documentation Preparation: Compile all required documents including Device Master File, Plant Master File, risk management files, and quality system documentation.
4. License Application (Form MD7): Submit the MD9 license application through the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: Attend the detailed manufacturing site audit conducted by CDSCO officials.
6. Queries and Clarifications: Respond promptly to any queries raised by authorities or during the audit.
7. Grant of MD9 License (Form MD9): Upon successful review and audit, the license is granted.

Manufacturers should engage early with CDSCO and testing labs to anticipate and address any technical or compliance issues.

Manufacturing License Documents Required for MD9

For a Class D device manufacturing license, the following documents are essential:

• Company Constitution (Incorporation Certificate, MOA, AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• List and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing device design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File covering manufacturing facility details (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File specific to the Intravascular Occluding Catheter (Risk Management)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Labels, Instructions For Use (IFU), and packaging details
• Quality Management System Documents (ISO 13485 certification preferred)

Organizing these documents meticulously expedites the review process and reduces back-and-forth with regulators.

Import License Process (MD15) for Intravascular Occluding Catheter

Importers aiming to bring Intravascular Occluding Catheters into India must apply for the MD15 license through the CDSCO central authority. This process generally takes 5-6 months and does not require a test license but demands comprehensive documentation.

Steps involved:

1. Document Compilation: Prepare all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and Indian-specific documents.
2. Application Submission: File the application using Form MD14 on the CDSCO MD Online Portal.
3. Review and Queries: Address any clarifications or additional documentation requests.
4. Grant of MD15 License: After satisfactory review, the import license is issued.

Import License Documents Required for MD15

Key documents for import license include:

• Valid Manufacturing License from exporting country
• Free Sale Certificate confirming market access in the country of origin
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate or equivalent international regulatory approval
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution Documents

Timely submission of complete documentation reduces the risk of delays.

Timeline and Processing Duration

Planning ahead and initiating testing and documentation early is critical. We recommend starting at least 6 months before intended market launch.

Government Fees and Costs

Additional costs include testing fees at government-approved labs and audit-related expenses. Factoring in these costs during budgeting avoids surprises.

Common Challenges and Solutions

• Delayed Product Testing: CDSCO-approved labs often have backlogs. Engage labs early and consider multiple testing sites to expedite.
• Incomplete Documentation: Ensure all required documents are accurate and updated; use checklists to avoid omissions.
• Audit Non-compliance: Conduct internal pre-audits to identify gaps in quality systems and facility compliance.
• Query Resolution Delays: Respond promptly and clearly to CDSCO queries to prevent unnecessary hold-ups.

Our experience with over 500 successful licensing cases shows proactive planning and expert guidance mitigates most challenges.

Expert Consultation and Support

Navigating Class D device licensing requires specialized expertise. We provide end-to-end regulatory consulting including:

• Comprehensive dossier preparation
• Coordination with CDSCO and notified bodies
• Pre-audit readiness assessments
• Training on risk management and essential principles

Our team stays abreast of evolving regulations and offers tailored strategies for smooth approvals.

Getting Started with Your CDSCO License Application

To initiate your licensing process for Intravascular Occluding Catheters:

1. Register on the CDSCO MD Online Portal to access application forms and track submissions.
2. Engage a CDSCO-approved testing laboratory early to schedule product tests.
3. Prepare your Device Master File and Plant Master File meticulously, referencing our detailed guides.
4. Compile all statutory and technical documents as per MD9 requirements.
5. Plan for pre-audit inspections and internal quality checks.

By following these steps and leveraging expert support, manufacturers and importers can confidently navigate the complex regulatory landscape for Intravascular Occluding Catheters and achieve timely market access in India.