CDSCO License for Occlusion Catheter

Comprehensive Guide to CDSCO Licensing for Occlusion Catheters (Class D Medical Device)

As a trusted regulatory consultant with over 25 years of experience assisting more than 500 companies, we understand the challenges manufacturers and importers face when entering the Indian medical device market. The Occlusion Catheter, classified as a Class D device due to its high-risk nature, requires stringent compliance with the Central Drugs Standard Control Organization (CDSCO) regulations. This detailed guide covers everything you need to know about obtaining your CDSCO license efficiently and compliantly.

Understanding Occlusion Catheters and Their Regulatory Importance

Occlusion Catheters are specialized medical devices intended for insertion or development at any stage during intravenous (IV) therapy. Given their critical role in patient care and the potential risks involved, the Indian regulatory framework treats these devices with utmost seriousness. The official notification 29/Misc/3/2017-DC (292) dated 06.06.2018 formally classifies Occlusion Catheters under Class D, mandating the highest level of regulatory oversight.

CDSCO Regulatory Framework for Occlusion Catheters

The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, categorizing devices into four risk classes (A to D). Occlusion Catheters fall under Class D, which includes devices that are implantable or potentially life-supporting, and hence require Central Licensing Authority approval.

Accordingly, manufacturers and importers must obtain the MD9 manufacturing license or MD15 import license respectively, following a comprehensive process involving testing, documentation, audits, and compliance verification.

Risk Classification and License Requirements for Occlusion Catheters

Class D devices like Occlusion Catheters demand rigorous compliance including testing in government-approved labs and audits by CDSCO inspectors or notified bodies.

Manufacturing License Process (MD9) for Occlusion Catheters

Obtaining an MD9 license is a multi-step journey:

1. Test License (Form MD13): Apply for a test license which takes approximately 1.5 to 2 months. This allows you to manufacture the device batch for testing purposes.

2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories to validate safety and performance. Refer to the list of testing laboratories for approved facilities.

3. Document Preparation: Compile a comprehensive dossier including Device Master File, Plant Master File, Risk Management File, and essential principles checklist.

4. Application Submission (Form MD7): Submit the MD9 license application via the CDSCO MD Online Portal.

5. Audit: CDSCO inspectors conduct an on-site audit verifying compliance with quality systems and manufacturing practices.

6. Query Resolution: Address any queries or deficiencies raised by CDSCO during the review process promptly.

7. License Grant (Form MD9): Upon satisfactory evaluation, the MD9 manufacturing license is issued.

For a detailed step-by-step guide, consult our MD9 License Guide.

Manufacturing License Documents Required for Occlusion Catheters

The following documentation is critical for successful MD9 license approval:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualifications and Experience Details
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device description, manufacturing process, and validation. Learn how to prepare your DMF here.
• Plant Master File (PMF): Manufacturing facility details and quality system overview. See our PMF guide here.
• Essential Principles Compliance Checklist
• Risk Management File aligned with ISO 14971 standards. For implementing risk management, refer here.
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Occlusion Catheters

For importers, the MD15 license process requires:

1. Document Preparation: Collect all necessary documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE certificate, and product-specific dossiers.

2. Application Submission (Form MD14): File the application on the CDSCO MD Online Portal.

3. Review and Queries: CDSCO reviews the application and may raise queries for clarification.

4. License Grant (Form MD15): Upon satisfactory review, the import license is granted.

Unlike manufacturing licenses, no test license or product testing is mandatory for import licenses, but documentation and compliance remain stringent.

Refer to our detailed Import License Guide for further insights.

Import License Documents Required

• Valid Manufacturing License of foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License for importers
• Company Constitution and Incorporation Certificate
• Product Labels and IFU

Timeline and Processing Duration

Planning ahead is crucial. We recommend initiating the test license process well before the intended manufacturing start date to accommodate testing and audit timelines.

Government Fees and Costs

Note that these fees exclude costs related to product testing, consultancy, and document preparation.

Common Challenges and Practical Solutions

• Delays in Testing: Scheduling tests at government-approved labs can be time-consuming. Early booking and choosing less crowded labs help mitigate delays.

• Audit Readiness: Non-compliance during audits leads to query backlogs. Maintaining updated QMS and thorough internal audits can smooth the CDSCO inspection process.

• Documentation Gaps: Incomplete dossiers are a common cause for rejection. Utilize checklists and expert reviews to ensure completeness.

• Query Management: Prompt, detailed responses to CDSCO queries are essential. Assign dedicated resources for communication to avoid processing delays.

Expert Consultation and Support

Navigating the CDSCO licensing maze requires expertise. Our team has successfully supported 500+ clients in obtaining MD9 and MD15 licenses for high-risk devices like Occlusion Catheters. We offer:

• End-to-end application preparation
• Compliance gap analysis
• Audit preparation and mock inspections
• Risk management and QMS implementation

Partnering with us reduces risk, accelerates approvals, and ensures regulatory compliance.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device risk class via the Medical Device Classification tool.

2. Compile Required Documentation: Begin assembling your Device Master File, Plant Master File, and Risk Management File.

3. Apply for Test License (for MD9): Submit Form MD13 through the CDSCO MD Online Portal to initiate product testing.

4. Schedule Testing: Coordinate with approved laboratories early to avoid bottlenecks.

5. Prepare for Audit: Conduct internal audits and document reviews to ensure readiness.

6. Submit Manufacturing License Application: File Form MD7 with complete documentation and testing reports.

7. Engage with CDSCO: Respond swiftly to any queries or inspection requirements.

By following these actionable steps and leveraging expert support, you can successfully obtain your CDSCO license for Occlusion Catheters, enabling market access in India’s rapidly growing healthcare sector.