CDSCO License for Intracardiac Mapping, High  Density Array Catheter

Introduction: Understanding Intracardiac Mapping High Density Array Catheters and Regulatory Importance

Intracardiac Mapping High Density Array Catheters are advanced Class D medical devices designed to map complex arrhythmias within the right atrium and assess the effectiveness of ablation treatments. Given their critical role in cardiac care and potential patient risk, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing or manufacturing in India.

With over 25 years of experience and having supported 500+ companies in navigating CDSCO licensing, we understand the nuances and complexities involved in obtaining approval for such high-risk devices. This comprehensive guide offers practical insights, timelines, fees, and document requirements tailored specifically for Intracardiac Mapping Catheters.

CDSCO Regulatory Framework for Class D Catheters

Medical devices in India are regulated under the Medical Device Rules (MDR) 2017, issued by CDSCO. Devices are classified A to D based on risk, with Class D representing the highest risk category—which includes invasive devices like intracardiac catheters.

The regulatory framework mandates that Class D devices obtain a manufacturing license (MD9) or an import license (MD15) from the Central Licensing Authority before being manufactured or imported.

Risk Classification and License Requirements for Intracardiac Mapping Catheters

• Device: Intracardiac Mapping High Density Array Catheter
• Risk Class: D (High risk due to cardiac invasive use)
• License Type: MD9 Manufacturing License for domestic manufacturing
• Regulatory Notification: 29/Misc/3/2017-DC (292) dated 06.06.2018

Class D devices require stringent compliance, including product testing, detailed documentation, and audits by CDSCO inspectors.

Manufacturing License Process (MD9) for Class D Devices

The MD9 license process is centralized and includes several critical steps:

1. Test License (Form MD13): Before applying for MD9, manufacturers must obtain a test license for their device. This allows initial manufacturing for testing purposes.
2. Product Testing: Conduct product testing at CDSCO-approved laboratories to confirm compliance with Indian standards.
3. Preparation of Technical Documentation: Including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
4. Application Submission: Apply for MD9 license using Form MD7 via the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: The manufacturing site and QMS undergo inspection.
6. Query Resolution: Respond to any queries raised by CDSCO.
7. License Grant: Upon satisfactory review, the MD9 license is issued on Form MD9.

For detailed guidance, refer to our MD9 License Guide.

Manufacturing License Documents Required for Intracardiac Mapping Catheters

To ensure a smooth application process, the following documents must be meticulously prepared:

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, materials, and specifications (Device Master File Guide)
• Plant Master File (PMF) covering manufacturing processes and facilities (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File adhering to ISO 14971 (Risk Management Guidance)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product Labels, Instructions For Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Intracardiac Mapping Catheters

If you intend to import the Intracardiac Mapping High Density Array Catheter, an MD15 import license from the Central Licensing Authority is required.

Key steps include:

1. Document Preparation: Collect all relevant technical documents, including Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF and PMF, wholesale license, and company incorporation documents.
2. Application Submission: File Form MD14 for MD15 license through the CDSCO MD Online Portal.
3. Queries and Clarifications: Address any department queries promptly.
4. License Grant: Issued on Form MD15 upon approval.

For more detailed insights, see our Import License Guide.

Timeline and Processing Duration

• MD9 Manufacturing License: Approximately 4-5 months total

  • Test License (MD13): 1.5-2 months
  • Product Testing: 3-4 weeks
  • Document Preparation and Submission: 2-3 weeks
  • Audit and Query Resolution: 4-6 weeks

• MD15 Import License: Approximately 5-6 months

Timelines may fluctuate depending on the completeness of documentation and query resolution efficiency.

Government Fees and Costs

For Intracardiac Mapping Catheters (Class D):

• MD9 Manufacturing License:

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

• Test License (MD13): Separate nominal fee as per CDSCO norms

• MD15 Import License:

  • Per Site Fee: $3,000
  • Per Product Fee: $1,500

Note: Additional costs include testing fees at government-approved laboratories and audit fees by notified bodies.

Common Challenges and Solutions

• Incomplete Documentation: Ensure thorough preparation of Device and Plant Master Files, including risk management and essential principles compliance. Utilize our comprehensive guides to prevent common pitfalls.

• Testing Delays: Engage with CDSCO-approved labs early to schedule testing and avoid bottlenecks. Refer to the official Testing Laboratories list.

• Audit Non-Compliance: Prepare your manufacturing facility and QMS meticulously. Consider pre-audit checks by consultants experienced in MD9 audits to ensure readiness.

• Query Resolution Delays: Assign dedicated regulatory personnel to promptly address CDSCO queries to expedite license issuance.

Expert Consultation and Support

Navigating CDSCO licensing for high-risk devices like Intracardiac Mapping Catheters requires deep domain expertise. We have successfully assisted over 500 manufacturers and importers, providing end-to-end support—from document preparation to audit readiness and query resolution.

Our team can help you:

• Develop compliant Device and Plant Master Files
• Coordinate with CDSCO-approved testing labs
• Prepare for and facilitate CDSCO audits
• Manage timely submission and follow-ups via the CDSCO MD Online Portal

Getting Started with Your CDSCO License Application

1. Assess Your Product Classification: Confirm your device is Class D via the Medical Device Classification resource.
2. Initiate Test License Application: File Form MD13 to obtain the test license allowing manufacturing for testing.
3. Engage an Approved Testing Laboratory: Schedule product testing early to avoid delays.
4. Prepare Complete Documentation: Use our Device Master File guide and Plant Master File guide to assemble comprehensive files.
5. Submit MD9 Application: After test license and testing, apply via Form MD7 on the CDSCO portal.
6. Prepare for Audit: Coordinate with a notified body or CDSCO inspectors for facility inspection.
7. Respond to Queries Quickly: Assign a dedicated team member to handle communications with CDSCO.

By following these actionable steps and leveraging expert support, you can streamline your path to obtaining your MD9 manufacturing license for Intracardiac Mapping High Density Array Catheters, ensuring timely entry into the Indian market.

For personalized assistance, reach out to our regulatory consultancy team with 25+ years of experience in CDSCO medical device licensing.