CDSCO License for Cardiac septostomy catheter, balloon

Comprehensive Guide to CDSCO Licensing for Cardiac Septostomy Balloon Catheters (Class C Medical Device)

As trusted regulatory consultants with over 25 years of experience and having successfully assisted more than 500 manufacturers and importers, we understand the critical importance of obtaining the correct CDSCO license for your medical device. The cardiac septostomy catheter, balloon—a single-use pediatric device designed to facilitate atrial septal defect enlargement in infants with congenital cardiac malformations—falls under Class C risk according to CDSCO's classification. This guide covers everything you need to know to efficiently navigate the regulatory landscape for this device type.

CDSCO Regulatory Framework for Cardiac Septostomy Balloon Catheters

India’s Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017, amended periodically to align with global standards. The cardiac septostomy catheter, balloon is categorized under Class C, indicating a moderate to high risk due to its critical role in neonatal cardiac interventions.

The regulatory framework mandates that manufacturers and importers obtain a manufacturing license (MD9) or import license (MD15) from the Central Licensing Authority, which is CDSCO headquartered in New Delhi.

Risk Classification and License Requirements for Cardiac Septostomy Catheters

Your device is classified as Class C per the official notification (File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021). This classification involves a stringent scrutiny process requiring:

• Manufacturing License: MD9 (using Application Form MD7) for domestic manufacturing
• Import License: MD15 (using Application Form MD14) for imported devices

Class C devices demand rigorous compliance due to their life-saving usage in neonates.

Manufacturing License Process (MD9) for Cardiac Septostomy Balloon Catheters

The MD9 license is issued by the Central Licensing Authority. The entire licensing process typically spans 4 to 5 months and involves several steps:

1. Test License Application (Form MD13): Initially, obtain a test license which generally takes 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at CDSCO-approved government labs to verify safety and performance. Refer to the list of testing laboratories.
3. Document Preparation: Compile all required technical and quality documentation (detailed below).
4. Application Submission: File the manufacturing license application via the CDSCO MD Online Portal using Form MD7.
5. Inspection and Audit: CDSCO inspectors will conduct on-site audits assessing compliance with MDR and QMS.
6. Query Resolution: Address any departmental queries promptly.
7. License Grant: Upon satisfactory evaluation, the MD9 license is granted.

Manufacturing License Documents Required for MD9

Accurate and comprehensive documentation is paramount. For your cardiac septostomy catheter, ensure submission of:

• Company Constitution (incorporation certificates)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed design, manufacturing process, and materials; see our Device Master File guide
• Plant Master File (PMF): Manufacturing environment, equipment, and quality systems; refer to our Plant Master File guide
• Essential Principles Checklist compliance document
• Risk Management File outlining hazard analysis and mitigations, aligned with ISO 14971; learn more at our Risk Management resource
• 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 Cardiac Septostomy Balloon Catheters

If you are importing this device, the MD15 import license is mandatory. This license is issued by the Central Licensing Authority, with a usual processing period of 5 to 6 months.

The process includes:

1. Document Preparation: Compile all necessary documentation (see next section).
2. Application Submission: Submit through the CDSCO MD Online Portal on Form MD14.
3. Query Resolution: Respond promptly to CDSCO queries.
4. Grant of License: After review, the MD15 import license is issued.

Notably, a test license is not required for imports, but thorough documentation verification is mandatory.

Import License Documents Required for MD15

Key documents include:

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

For your Class C cardiac septostomy catheter:

• MD9 Manufacturing License:
  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000
• MD15 Import License:
  • Site Fee: $3,000
  • Per Product Fee: $1,500

Additional costs include testing fees at government-approved labs and potential consultancy fees.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with MDR requirements.

Solution: Engage with expert consultants early to prepare your Device and Plant Master Files meticulously. Our guides on MD9 License and Risk Management can be invaluable.

Challenge: Scheduling and passing government laboratory testing.

Solution: Pre-qualify your product through internal testing and select labs from the official Testing Laboratories list to avoid last-minute surprises.

Challenge: Audit non-conformities.

Solution: Conduct internal audits and gap assessments before CDSCO inspections and maintain up-to-date QMS documentation.

Expert Consultation and Support

Navigating CDSCO licensing for critical devices like cardiac septostomy catheters requires precision and experience. Our team offers tailored consultancy to streamline your application, prepare regulatory dossiers, and liaise with CDSCO authorities, ensuring a smoother approval process.

Getting Started with Your CDSCO License Application

1. Assess your device classification and intended regulatory pathway: Confirm your device as Class C and decide if you are manufacturing or importing.
2. Gather and prepare documentation: Initiate preparation of your Device Master File, Plant Master File, and QMS documents.
3. Apply for test license (MD13) if manufacturing: Submit your test license application via the CDSCO MD Online Portal.
4. Schedule product testing: Coordinate with CDSCO-approved labs.
5. Compile complete application: Once testing is complete, submit MD9 or MD15 application through the portal.
6. Prepare for audit: Conduct internal quality audits and readiness checks.
7. Engage expert support: Utilize experienced consultants to manage queries and facilitate timely license grant.

By following these steps and leveraging our expertise, your cardiac septostomy balloon catheter can gain timely access to the Indian market, helping improve neonatal cardiac care outcomes.

For detailed assistance, please contact our regulatory specialists to discuss your project and receive personalized guidance.

For further reading and resources, explore our comprehensive guides on MD9 Licensing and Import License Process.