CDSCO License for Electrode  Recording Probe, Electrode  Recording Catheter

Comprehensive Guide to CDSCO Licensing for Electrode Recording Probe and Catheter (Class D Medical Device)

At our consultancy, with over 25 years of experience and having assisted 500+ medical device manufacturers and importers, we understand the critical nuances involved in navigating the CDSCO licensing process for high-risk Class D devices such as Electrode Recording Probes and Catheters. These cardiac catheters containing electrodes are pivotal in pacing and delivering high-energy shocks to the heart, and therefore, require stringent regulatory compliance to ensure patient safety and efficacy.

CDSCO Regulatory Framework for Electrode Recording Probes and Catheters

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India under the Medical Device Rules (MDR) 2017, notified under the Drugs and Cosmetics Act. Electrode Recording Probes and Catheters fall under Class D due to their high risk, necessitating approval from the Central Licensing Authority.

Risk Classification and License Requirements for Class D Devices

Class D devices are the highest risk category and include implantable and life-supporting devices. For Electrode Recording Probes and Catheters, the CDSCO mandates an MD9 manufacturing license for domestic production and an MD15 import license for foreign manufacturers or importers. The MD9 license involves a rigorous evaluation process including testing, audit, and documentation review, reflecting the critical nature of these devices.

Manufacturing License Process for Electrode Recording Probes and Catheters (MD9)

The MD9 license application process is centralized and typically spans 4-5 months:

1. Test License (Form MD13): Initially, the applicant must secure a test license for the device, which takes approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories. The list of government-approved testing laboratories is available on the CDSCO portal.
3. Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission (Form MD7): Submit the MD9 license application through the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: The Central Licensing Authority conducts a detailed audit of manufacturing premises and processes.
6. Queries Resolution: Address any queries raised by the CDSCO department or inspectors promptly.
7. License Grant (Form MD9): Upon successful evaluation, the MD9 manufacturing license is granted.

For an in-depth walkthrough, our MD9 License Guide offers practical insights.

Manufacturing License Documents Required for Class D Electrode Catheters

• Company Constitution and Incorporation Certificates
• Proof of Ownership/Rental Agreement of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) outlining design and specifications (Detailed DMF Guide)
• Plant Master File (PMF) detailing manufacturing processes (PMF Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating compliance with risk standards (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (ISO 13485) documentation

Import License Process for Electrode Recording Probes and Catheters (MD15)

Importers must apply for an MD15 license through the CDSCO Central Licensing Authority, with an expected timeline of 5-6 months:

1. Document Preparation: Assemble all required import documents.
2. Application Submission (Form MD14): File your application via the CDSCO MD Online Portal.
3. Evaluation and Queries: Respond to any queries from the department.
4. License Grant (Form MD15): Receive the import license upon approval.

Unlike manufacturing, no test license is required for import applications.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate or Equivalent
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

Government Fees and Costs

• MD9 Manufacturing License: Rs 50,000 per application + Rs 1,000 per product
• MD15 Import License:
  • Class C & D devices: USD 3,000 per site + USD 1,500 per product

These fees are payable via the online portal.

Common Challenges and Solutions

Challenge 1: Delays due to incomplete documentation

• Solution: Utilize detailed checklists and experienced consultants to ensure all documents including DMF, PMF, and Risk Management files are comprehensive and compliant.

Challenge 2: Testing delays at government labs

• Solution: Engage early with approved labs for scheduling and sample submission to avoid bottlenecks.

Challenge 3: Audit non-conformities

• Solution: Conduct internal pre-audit checks and mock inspections to identify gaps prior to CDSCO audit.

Challenge 4: Query handling delays

• Solution: Assign dedicated regulatory personnel to respond promptly and accurately to CDSCO queries.

Expert Consultation and Support

Leveraging our 25+ years of regulatory expertise, we provide end-to-end support from initial classification assessment to final license grant. Our services include:

• Comprehensive gap analysis for your documentation
• Assistance with device testing coordination
• Preparation and submission of license applications on the CDSCO MD Online Portal
• Pre-audit readiness and representation during CDSCO inspections
• Post-approval compliance and renewal management

Getting Started with Your CDSCO License Application

1. Confirm Device Classification: Since Electrode Recording Probes and Catheters are Class D devices, prepare for the MD9 manufacturing or MD15 import license accordingly.
2. Initiate Test License Process: Apply for Form MD13 via the CDSCO portal to commence product testing.
3. Gather Required Documentation: Begin assembling all technical and legal documents, leveraging our Device Master File and Plant Master File guides.
4. Engage with Approved Testing Labs: Schedule testing early to coincide with your test license validity.
5. Prepare for CDSCO Audit: Conduct internal audits and ensure QMS compliance before the CDSCO inspection.
6. Submit Application: File your MD9 or MD15 application through the CDSCO MD Online Portal.
7. Respond to Queries Promptly: Assign resources to monitor and reply to CDSCO queries to avoid delays.

For tailored support and to navigate this complex process smoothly, contact our expert regulatory team. We specialize in facilitating swift and compliant CDSCO approvals for critical Class D medical devices like Electrode Recording Probes and Catheters, helping you bring life-saving technologies to the Indian market efficiently.