CDSCO License for Intra-Aortic  System Balloon and Control

Comprehensive Guide to CDSCO Licensing for Intra-Aortic System Balloon and Control (Class D Catheters)

As a specialized medical device regulatory consultancy with over 25 years of experience and 500+ successful CDSCO license approvals, we understand the unique challenges manufacturers and importers face when entering the Indian market—especially with high-risk devices like the Intra-Aortic System Balloon and Control. This mechanical catheter device, intended to increase myocardial oxygen perfusion and cardiac output, is classified under Risk Class D by CDSCO, per Notification 29/Misc/3/2017-DC (292) dated 06.06.2018. Navigating the regulatory framework for such critical devices requires precise knowledge of classification, documentation, timelines, and fees.

CDSCO Regulatory Framework for Intra-Aortic Balloon Systems

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules 2017. For Class D devices like the Intra-Aortic Balloon System, the regulatory oversight is stringent due to the device’s critical function and patient safety impact. Licensing for manufacturing is handled by the Central Licensing Authority, requiring an MD9 license, while importers must obtain an MD15 license.

Risk Classification and License Requirements for Class D Catheters

Class D devices represent the highest risk category, including implantable and life-supporting devices such as intra-aortic balloon pumps. This classification mandates:

• Manufacturing License: MD9 license obtained via Form MD7, granted by CDSCO Central Licensing Authority.
• Import License: MD15 license obtained via Form MD14, also granted centrally.

Both processes involve rigorous testing, documentation review, and inspections to ensure full compliance with Indian regulatory standards.

Manufacturing License Process for Intra-Aortic Balloon System (MD9 License)

The manufacturing license process for Class D devices involves multiple stages:

1. Test License (Form MD13): Before full manufacturing license application, a test license is required to facilitate product testing. This stage takes approximately 1.5 to 2 months.

2. Product Testing: Testing must be conducted at CDSCO-approved laboratories to validate safety and performance. Refer to the list of approved testing laboratories for selecting the right facility.

3. Documentation Preparation: Compile comprehensive technical documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, Quality Management System (QMS) documents, and others.

4. Application Submission: Apply online through the CDSCO MD Online Portal using Form MD7.

5. Inspection: CDSCO inspectors conduct a detailed audit of manufacturing facilities and QMS compliance.

6. Query Resolution: Address any queries raised by the licensing authority or audit team promptly.

7. License Grant: Upon successful review and audit, the MD9 manufacturing license is granted.

Total Timeline

The entire MD9 licensing process typically takes 4 to 5 months from test license application to license issuance.

Manufacturing License Documents Required for MD9

For Class D devices like the Intra-Aortic Balloon System, the following documents are mandatory:

• Company Constitution/Registration documents
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed design, specifications, and manufacturing process. Our Device Master File guide can help streamline this.
• Plant Master File (PMF): Information on facilities and quality systems. See our Plant Master File guide for best practices.
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File demonstrating hazard identification and mitigation per ISO 14971 standards. Learn more about medical device risk management.
• Test Reports from CDSCO-approved labs
• Labeling, Instructions for Use (IFU), and packaging details
• Quality Management System (QMS) documents including ISO 13485:2016 certification

Import License Process for Intra-Aortic Balloon System (MD15 License)

Importers of Class D devices must secure an MD15 import license:

1. Document Preparation: Gather prerequisite documents including the manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), DMF, PMF, and wholesale license.

2. Application Submission: File the application online using Form MD14 on the CDSCO MD Online Portal.

3. Query Resolution: Respond to any CDSCO queries promptly to avoid delays.

4. License Issuance: After review, the MD15 import license is granted.

Timeline

The MD15 import license process generally takes 5 to 6 months.

Import License Documents Required for MD15

• Valid Manufacturing License (MD9 for Class D devices)
• Free Sale Certificate or equivalent from the country of origin
• ISO 13485:2016 certification
• CE Certificate or other international approvals
• Device Master File and Plant Master File
• Wholesale License for distribution
• Company Constitution and relevant business registrations

Government Fees and Costs for Class D Devices

• MD9 Manufacturing License:

  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000

• MD15 Import License:

  • Application Fee: ₹3,000 (per site)
  • Per Product Fee: ₹1,500

Manufacturers should budget for additional costs including testing fees at government-approved labs, notified body audits, and consultancy charges if applicable.

Common Challenges and Practical Solutions

Challenge 1: Delays in Testing and Audit

• Solution: Plan your testing early and select CDSCO-approved labs with known turnaround times. Pre-audit internal reviews can minimize issues during official inspections.

Challenge 2: Documentation Gaps

• Solution: Use our detailed Device Master File and Plant Master File templates to ensure comprehensive documentation.

Challenge 3: Query Management

• Solution: Assign a dedicated regulatory liaison to monitor and respond promptly to CDSCO queries to avoid processing delays.

Expert Consultation and Support

With our extensive track record supporting over 500 companies, we provide end-to-end assistance including:

• Regulatory strategy and device classification
• Preparation of technical files and master files
• Coordination with testing labs and notified bodies
• Timely application submission and follow-up
• Audit readiness and gap analysis

Our expertise ensures a smooth, compliant path from product development to market entry.

Getting Started with Your CDSCO License Application for Intra-Aortic Balloon Systems

1. Assess Your Device Classification: Confirm Class D status using tools like our Medical Device Classification guide.

2. Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the application interface at CDSCO MD Online Portal.

3. Gather Required Documentation: Begin compiling your Device and Plant Master Files, risk management documentation, and QMS certifications.

4. Apply for Test License (MD13): Initiate the testing phase early to meet timelines.

5. Engage with a Notified Body: For the MD9 license audit, select from the list of notified bodies authorized by CDSCO.

6. Plan for Audit and Inspection: Prepare your facility and documentation meticulously to ensure successful audits.

7. Apply for Manufacturing (MD9) and Import (MD15) Licenses: Submit your applications promptly and manage query responses efficiently.

Navigating the CDSCO licensing process for high-risk devices like the Intra-Aortic Balloon System requires precise planning and expert knowledge. Our dedicated regulatory team is here to guide you every step of the way to ensure timely market access and regulatory compliance in India.