CDSCO License for Intra-aortic balloon and control system
Medical Device Information
Intended Use
It is a medical device which is placed in the aorta to improve cardiovascular functioningduringcertain life- threatening emergencies.
Comprehensive Guide to CDSCO Licensing for Intra-Aortic Balloon and Control Systems
Intra-aortic balloon and control systems are critical Class D medical devices designed to support cardiovascular function during life-threatening emergencies. Given their high-risk nature and vital role in patient care, stringent regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) in India ensures these devices meet safety and efficacy standards before market entry.
With over 25 years of experience assisting 500+ manufacturers and importers, we offer detailed insights to streamline your CDSCO licensing process for this device category.
CDSCO Regulatory Framework for Intra-Aortic Balloon and Control Systems
The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, classifying devices based on risk. Intra-aortic balloon and control systems fall under Class D, the highest risk category due to their invasive nature and critical clinical application. These devices require a central licensing authority approval and rigorous compliance.
Risk Classification and License Requirements
- Device: Intra-aortic balloon and control system
- Category: Catheters
- Risk Class: D (highest risk)
- Notification: 29/Misc/3/2017-DC (292), dated 06.06.2018
Class D devices necessitate obtaining an MD9 manufacturing license for Indian manufacturers or an MD15 import license for importers, both granted by the CDSCO Central Licensing Authority.
Manufacturing License Process (MD9) for Class D Devices
The MD9 license process is comprehensive and typically takes 4-5 months from start to finish. It involves several key steps:
- Test License (Form MD13): Initially, apply for a test license, which takes about 1.5 to 2 months. This allows product testing in CDSCO-approved labs.
- Product Testing: Testing must be conducted at government-recognized laboratories to validate safety and performance.
- Document Preparation: Assemble detailed technical documents including Device Master File and Plant Master File.
- MD9 Application (Form MD7): Submit your manufacturing license application via the CDSCO MD Online Portal.
- Inspection & Audit: CDSCO inspectors will conduct on-site audits to verify compliance with Good Manufacturing Practices (GMP).
- Query Resolution: Respond promptly to any queries raised by CDSCO.
- License Grant: Upon satisfactory review, CDSCO issues the MD9 license.
Manufacturing License Documents Required
For your Intra-aortic balloon and control system, ensure you have the following ready:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire and Pollution NOCs
- Device Master File (DMF) detailing design, materials, manufacturing process (Device Master File Guide)
- Plant Master File (PMF) covering facility layout, equipment, and quality controls (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with MDR
- Risk Management File per ISO 14971 standards (Risk Management Overview)
- Test Reports from CDSCO-approved labs (Testing Laboratories List)
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documentation (typically ISO 13485:2016)
Import License Process (MD15) for Intra-Aortic Balloon and Control Systems
For importers, the MD15 license process is managed by the CDSCO Central Authority and generally takes 5-6 months. The process steps are:
- Document Preparation: Gather all mandatory documents, including your foreign manufacturing license.
- Application Submission: File Form MD14 for import license through the CDSCO MD Online Portal.
- Review & Queries: Address any clarifications sought by CDSCO.
- License Issuance: Receive the MD15 license allowing import and sale in India.
Import License Documents Required
Key documents include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution
Timeline and Processing Duration
| License Type | Steps | Duration |
|---|---|---|
| MD9 (Manufacturing) | Test License → Testing → Audit → License | 4-5 months total |
| MD15 (Import) | Document Prep → Submission → Review → License | 5-6 months total |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee | Additional Costs |
|---|---|---|---|
| MD9 | ₹50,000 | ₹1,000 | Testing lab fees, audit costs |
| MD15 (Class D) | $3,000 (approx ₹2,40,000) | $1,500 (approx ₹1,20,000) | Translation, documentation, courier |
Note: Fees are subject to change; always verify on the CDSCO MD Online Portal.
Common Challenges and Solutions
- Delays in Test License Approval: Anticipate 1.5-2 months; submit meticulously filled applications with all supporting documents.
- Product Testing Complexities: Choose CDSCO-approved and experienced testing labs familiar with Class D devices.
- Audit Non-Compliance: Conduct thorough internal audits and mock inspections before CDSCO visits.
- Document Gaps: Maintain updated Device and Plant Master Files; utilize professional regulatory consultants for accuracy.
Expert Consultation and Support
Navigating the MD9 and MD15 licensing processes for a high-risk device like an intra-aortic balloon system demands expertise. We have supported over 500 companies, streamlining their regulatory journey by:
- Preparing comprehensive documentation compliant with MDR 2017
- Coordinating with CDSCO officials and notified bodies
- Facilitating product testing in approved labs
- Providing mock audits and gap analysis
Our tailored approach reduces approval times and mitigates compliance risks.
Getting Started with Your CDSCO License Application
- Determine Your Regulatory Path: Confirm whether you are manufacturing in India (MD9) or importing (MD15).
- Compile Preliminary Documents: Begin assembling your company and product dossiers.
- Apply for Test License (if manufacturing): Submit Form MD13 promptly to initiate product testing.
- Engage with Approved Labs: Schedule and complete product testing early to avoid bottlenecks.
- Consult Regulatory Experts: Engage experienced consultants to review your documents and audit readiness.
- Submit Application Online: Use the CDSCO MD Online Portal for all submissions to ensure traceability.
- Prepare for Inspections: Conduct internal audits and staff training ahead of CDSCO audits.
Embarking on your CDSCO licensing journey with a clear roadmap and expert support will significantly enhance your chances of timely approval, enabling your intra-aortic balloon system to reach Indian healthcare providers swiftly and compliantly.
For personalized assistance, please contact our regulatory consulting team to discuss your specific requirements and receive a tailored project plan.
