CDSCO License for Cardiac septostomy catheter, blade
Medical Device Information
Intended Use
A flexible tube with a collapsible blade at the distal end that, once in situ, can be raised to an acute angle by the surgeon operating an actuation lever at the proximal end for a blade atrial septostomy (BAS) procedure. It is used to enlarge the interatrial opening in cases of mitral atresia (a septal defect found in the hearts of infants) or unsuccessful or insufficient balloon atrial septostomy. This procedure allows interatrial blood mixing in infants with congenital cardiac malformations. It is typically made of plastic and high-grade stainless steel materials. This is a single-use device.
Comprehensive Guide to CDSCO Licensing for Cardiac Septostomy Catheter, Blade (Class C Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for critical pediatric devices like the Cardiac Septostomy Catheter, blade. This single-use device, designed for blade atrial septostomy procedures in infants with congenital heart defects, falls under Risk Class C according to CDSCO classification. With over 25 years of expertise and having supported 500+ companies in securing CDSCO approvals, we provide an in-depth, practical overview to help manufacturers and importers successfully obtain the MD9 Manufacturing License and MD15 Import License for this device.
Understanding the Cardiac Septostomy Catheter and Its Regulatory Importance
The Cardiac Septostomy Catheter, blade is an advanced, high-risk medical device utilized in critical pediatric cardiac interventions to enlarge interatrial septal openings. Given its invasive nature and use in vulnerable neonates, regulatory oversight is stringent to ensure patient safety and device efficacy.
The device’s Notification File No. 29/MiscJ03/2020-DC (150) dated 23.08.2021 classifies it under CDSCO's Risk Class C, requiring a Central Licensing Authority approval through the MD9 license pathway.
CDSCO Regulatory Framework for Class C Medical Devices
The Central Drugs Standard Control Organisation (CDSCO) governs the import and manufacture of Class C devices through the following key licenses:
- MD9 Manufacturing License (Form MD7): Mandatory for manufacturing Class C devices within India.
- MD15 Import License (Form MD14): Required to import Class C devices into the Indian market.
The entire process ensures compliance with Indian medical device rules, testing standards, and quality management systems.
Risk Classification and License Requirements for Cardiac Septostomy Catheter
Based on its intended use and potential risk, the Cardiac Septostomy Catheter is classified as Class C. According to CDSCO:
- MD9 license is mandatory for manufacturing.
- MD15 license is required for importers.
For detailed classification insight, visit our Medical Device Classification guide.
Step-by-Step Manufacturing License Process (MD9) for Cardiac Septostomy Catheter
Obtain Test License (Form MD13):
- Apply via the CDSCO MD Online Portal.
- Duration: 1.5 to 2 months.
- Purpose: To conduct mandatory product testing at government-approved labs.
Product Testing:
- Conduct testing at CDSCO recognized labs (see Testing Laboratories).
- Tests focus on biocompatibility, sterility, mechanical integrity, and performance.
Document Preparation:
- Prepare comprehensive technical documentation, including Device Master File (DMF), Plant Master File (PMF), risk management files, and QMS documents.
- Refer to our Device Master File Guide and Plant Master File Guide for detailed templates.
Application Submission (Form MD7):
- Submit application for MD9 license on the CDSCO MD Online Portal.
Audit by CDSCO Inspectors:
- On-site audit to verify compliance with manufacturing practices and QMS.
Query Resolution:
- Address any queries raised by CDSCO or auditors promptly.
Grant of MD9 License:
- Issued on Form MD9 upon satisfactory fulfillment of all requirements.
Essential Documents Required for MD9 License Application
- Company Constitution Documents (Certificate of Incorporation, MOA/AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification Proofs
- Fire NOC and Pollution Control NOC
- Device Master File (DMF)
- Plant Master File (PMF)
- Essential Principles Checklist
- Risk Management File (aligned with ISO 14971) — see our Risk Management guide
- Test Reports from Approved Labs
- Product Labels and Instructions for Use (IFU)
- **Quality Management System Documents (ISO 13485:2016 certification)"
Import License Process (MD15) for Cardiac Septostomy Catheter
Importers of the Cardiac Septostomy Catheter must apply for an MD15 license with the Central Licensing Authority as follows:
Document Preparation:
- Compile all necessary documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, wholesale license, and company constitution.
Application Submission:
- Submit Form MD14 for MD15 license on the CDSCO MD Online Portal.
Query Resolution:
- Respond to any queries or additional clarifications requested by CDSCO.
Grant of MD15 License:
- Issued upon satisfactory review.
Documents Required for MD15 Import License
- Valid Manufacturing License of Foreign Manufacturer
- Free Sale Certificate from Country of Origin
- ISO 13485:2016 Certification
- CE Certificate
- Device Master File & Plant Master File
- Wholesale License (if applicable)
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| MD9 Manufacturing License | 4 – 5 months (including test license and audit) |
| MD15 Import License | 5 – 6 months |
Government Fees and Costs for Cardiac Septostomy Catheter (Class C)
| License Type | Fees |
|---|---|
| MD9 License | Rs. 50,000 + Rs. 1,000 per product |
| MD15 License | USD 3,000 per site + USD 1,500 per product |
Fees are payable online via the CDSCO MD Online Portal and are subject to revision, so always verify current rates.
Common Challenges and Practical Solutions
Challenge 1: Delays in Product Testing
- Solution: Pre-schedule testing with notified labs and ensure complete sample and documentation submission.
Challenge 2: Audit Non-Compliance
- Solution: Conduct mock audits internally using the list of notified bodies guidelines and maintain rigorous QMS.
Challenge 3: Incomplete Documentation
- Solution: Use standardized templates for DMF and PMF and cross-verify against CDSCO checklists prior to submission.
Challenge 4: Query Resolution Delays
- Solution: Assign dedicated regulatory personnel for timely responses to CDSCO queries to avoid processing delays.
Expert Consultation and Support
Leveraging expert consultation can drastically reduce approval timelines and improve compliance quality. Our team has successfully assisted over 500 clients with Class C device licensing, offering:
- End-to-end documentation preparation
- Regulatory strategy and classification advice
- Liaison with notified bodies and CDSCO inspectors
- Mock audits and gap analysis
- Post-approval compliance support
Getting Started with Your CDSCO License Application for Cardiac Septostomy Catheter
- Register on the CDSCO MD Online Portal
- Self-assess your device classification and confirm Class C status
- Initiate the Test License (MD13) application to commence product testing
- Prepare and compile all required documents simultaneously
- Schedule testing with approved laboratories early to avoid bottlenecks
- Plan for the audit by ensuring QMS and plant compliance
- Submit MD9 license application upon successful testing and document readiness
By following this structured approach and utilizing expert guidance, manufacturers and importers can confidently navigate the CDSCO regulatory process for the Cardiac Septostomy Catheter, blade, ensuring timely market access and compliance with Indian medical device regulations.
For detailed licensing assistance, document templates, and personalized support, contact our regulatory experts today.
