CDSCO License for Intraaortic Balloon Catheter
Medical Device Information
Intended Use
It is indicated for use in patients undergoing cardiopulmonary bypass.
Comprehensive Guide to CDSCO Licensing for Intraaortic Balloon Catheter (Class D Medical Device)
As specialists with over 25 years of experience and having supported 500+ companies in navigating the Indian regulatory landscape, we understand the complexities manufacturers and importers face when entering the Indian medical device market. One such critical device is the Intraaortic Balloon Catheter, a Class D high-risk medical device intended for patients undergoing cardiopulmonary bypass.
This guide covers everything you need to know about obtaining the CDSCO MD9 manufacturing license, including step-by-step processes, timelines, costs, documentation, and practical tips specifically tailored for this device category.
CDSCO Regulatory Framework for Intraaortic Balloon Catheters (Class D Devices)
The Central Drugs Standard Control Organisation (CDSCO) governs the import and manufacturing of medical devices in India under the Medical Device Rules, 2017. The Intraaortic Balloon Catheter falls under the Class D category, representing the highest risk classification, requiring stringent regulatory controls.
Class D devices demand central licensing authority approval, adherence to rigorous quality management systems, clinical evaluations, and compliance with the notified essential principles.
For detailed classification criteria, refer to our Medical Device Classification guide.
Risk Classification and License Requirements for Class D Devices
- Risk Class: D (highest risk)
- License Type: MD9 Manufacturing License (Application Form MD7)
- Regulatory Authority: Central Licensing Authority (CDSCO Headquarters)
- Notification Reference: 29/Misc/3/2017-DC (292), dated 06.06.2018
Class D devices require a comprehensive audit, clinical evaluation documents, and product testing from CDSCO-approved laboratories.
Manufacturing License Process (MD9) for Intraaortic Balloon Catheter
The MD9 licensing pathway is a multi-step process typically extending over 4 to 5 months. The key stages are:
Test License Application (Form MD13): Before manufacturing license application, obtain a test license to manufacture the product for testing purposes. This takes approximately 1.5 to 2 months.
Product Testing: The device must be tested in CDSCO-approved labs to confirm compliance with Indian standards. Testing duration depends on the lab's workload but generally takes 4 to 6 weeks. Check the list of testing laboratories for accredited facilities.
Document Preparation: Compile all required documents, including Device Master File, Plant Master File, clinical evaluation reports, risk management files, and quality management system (QMS) documents.
License Application Submission (Form MD7): Submit the application through the CDSCO MD Online Portal.
Inspection and Audit: CDSCO inspectors conduct a detailed audit of manufacturing premises, QMS, and product documentation. Be prepared for rigorous scrutiny.
Query Resolution: Address any observations or queries raised by CDSCO officials promptly.
Grant of License: Upon successful audit and document verification, the MD9 manufacturing license (Form MD9) is granted.
For an in-depth walkthrough, see our MD9 License Guide.
Manufacturing License Documents Required for Class D Device
The documentation package for an Intraaortic Balloon Catheter MD9 license must be comprehensive and meticulously prepared. Typical documents include:
- Company Constitution: Incorporation certificate, partnership deed, or trust deed
- Proof of Premises Ownership or Lease: Registered sale deed or lease agreement
- Technical Staff Details: Qualification certificates and experience proof of technical personnel
- Fire NOC and Pollution Control NOC: Valid certificates from respective authorities
- Device Master File (DMF): Detailed product specifications, design, manufacturing process, and validation. Our Device Master File guide offers practical insights.
- Plant Master File (PMF): Details of manufacturing site, equipment, utilities, and process controls. Learn how to prepare a PMF with our Plant Master File Guide.
- Essential Principles Checklist: Declaration of conformity to CDSCO essential principles
- Risk Management File: Complete risk analysis and mitigation strategy based on ISO 14971. Visit our Risk Management resource for practical tips.
- Clinical Evaluation Report: For Class D devices, clinical data demonstrating safety and efficacy
- Test Reports: From CDSCO-approved laboratories
- Labels and Instructions for Use (IFU): Drafts compliant with CDSCO labeling requirements
- Quality Management System Documents: ISO 13485:2016 certification and SOPs
Import License Process (MD15) for Intraaortic Balloon Catheter
If you are an importer seeking to bring the Intraaortic Balloon Catheter into India, you need to apply for the MD15 Import License. The process usually takes around 5 to 6 months and involves:
Document Preparation: Including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master and Plant Master Files, Wholesale License, and Company Constitution.
Application Submission: Form MD14 submitted via the CDSCO MD Online Portal.
Query Resolution: Timely addressing of departmental queries.
Grant of License: Issuance of MD15 license.
The fee structure is based on risk class; for Class D devices, fees are approximately 1500 per product.
For detailed guidance, refer to our Import License Guide.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Compilation | 2 – 3 weeks |
| License Application (MD7) | Immediate upon document readiness |
| Audit and Inspection | 1 month |
| Query Resolution | 2 – 4 weeks |
| Total Time for MD9 License | Approx. 4 – 5 months |
For imports (MD15), the total duration is generally longer, about 5 to 6 months, given the additional document verification.
Government Fees and Costs
MD9 Manufacturing License Fees:
- Application Fee: INR 50,000
- Product Fee: INR 1,000 per product
Test License (MD13): Nominal fees apply depending on state authority.
Import License (MD15): Approximately 1,500 per product
Additional costs include product testing fees at government-approved labs (vary based on device complexity) and audit fees charged by notified bodies.
Common Challenges and Solutions
Delayed Document Preparation: Begin early with a dedicated regulatory team to compile accurate DMF, PMF, and clinical data.
Audit Non-Compliance: Conduct pre-audit internal assessments and engage with notified bodies listed on the CDSCO Notified Bodies List to ensure readiness.
Testing Delays: Schedule product testing well in advance, considering lab backlogs.
Query Management: Maintain clear communication channels with CDSCO and respond to queries promptly to avoid further delays.
Technical Staff Qualification Gaps: Invest in training and hiring qualified personnel compliant with CDSCO norms.
Expert Consultation and Support
Navigating the MD9 licensing process for a Class D device like the Intraaortic Balloon Catheter can be daunting. Our experienced consultants provide tailored support across all stages—from documentation, testing coordination, audit preparation to final license grant.
Our track record includes successfully helping over 500 companies, minimizing regulatory risks, and accelerating market entry.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your device is Class D under CDSCO rules.
Initiate Test License (MD13): Prepare and submit your application on the CDSCO MD Online Portal.
Plan Product Testing: Contact CDSCO-approved labs early to schedule testing.
Compile Key Documents: Follow our Device and Plant Master File guides to prepare compliant documents.
Engage with Notified Bodies: Identify and connect with a suitable notified body from the official list.
Submit Manufacturing License Application (MD7): Post successful testing and document preparation.
Prepare for Audit: Conduct internal audits and gap analysis.
Maintain Communication: Promptly address queries and requests from CDSCO.
By following these actionable steps and leveraging expert guidance, manufacturers and importers can successfully secure their MD9 license for the Intraaortic Balloon Catheter and access the growing Indian medical device market with confidence.
