CDSCO License for Ventricular bypass (assist) device

Comprehensive Guide to CDSCO Licensing for Ventricular Bypass (Assist) Devices – Class D Cardiovascular Medical Devices

As seasoned regulatory consultants with over 25 years of experience and a proven track record of assisting 500+ companies, we understand the complexities involved in securing CDSCO licenses for high-risk medical devices like the Ventricular Bypass (Assist) Device. This device, classified as Class D under the CDSCO framework, plays a critical role in supporting cardiac function by assisting the left or right ventricle to maintain circulatory blood flow. Given its implantable nature and life-sustaining function, regulatory compliance is not just mandatory but vital to ensure patient safety and market access.

CDSCO Regulatory Framework for Ventricular Bypass (Assist) Devices

The Ventricular Bypass Device falls under the cardiovascular category, notified under Notification No. 29/Misc./03/2020-DC (159) dated 26.7.2021. CDSCO classifies such devices as Class D due to their high risk, requiring the most stringent regulatory controls. Consequently, manufacturers must obtain the MD9 manufacturing license granted by the Central Licensing Authority.

Risk Classification and License Requirements

Class D devices, including ventricular assist devices, require:

• An MD9 manufacturing license (Form MD7) for domestic manufacturing
• Rigorous testing from government-approved laboratories
• Comprehensive documentation including device master files and risk management documentation

This classification ensures the highest level of scrutiny in terms of quality management, safety, and efficacy. For importers, an MD15 import license is mandatory.

Manufacturing License Process (MD9 License)

The MD9 license process is detailed and methodical, typically spanning 4 to 5 months. Here's a stepwise overview:

1. Test License Application (Form MD13): The process begins with obtaining a test license, which takes approximately 1.5 to 2 months. This allows the manufacturer to produce samples for mandatory testing.
2. Product Testing: Samples must be tested at CDSCO-approved laboratories (Testing Laboratories). Testing includes biocompatibility, electrical safety, and performance validation as per Indian standards.
3. Document Preparation: Parallelly, prepare all required documents including Device Master File and Plant Master File, which detail device specifications and manufacturing processes respectively.
4. License Application (Form MD7): Submit the MD9 license application via the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: After document verification, CDSCO conducts a thorough audit of manufacturing facilities and quality systems.
6. Queries & Resolution: Address any queries raised by CDSCO promptly to avoid delays.
7. License Grant: Upon satisfactory audit and documentation, CDSCO issues the MD9 manufacturing license.

For a detailed walkthrough, refer to our MD9 License Guide.

Manufacturing License Documents Required

The documentation package for a Class D device like the ventricular bypass includes:

• Company Constitution and Incorporation Certificates
• Proof of ownership or lease of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) covering quality control and facility details (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File documenting hazard analysis and mitigation strategies (Risk Management)
• Test Reports from CDSCO approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documents including ISO 13485:2016 certification

Ensuring completeness and accuracy of these documents is crucial to minimize back-and-forth with CDSCO.

Import License Process (MD15 License)

For importers of ventricular bypass devices, the MD15 license is mandatory. The process spans approximately 5 to 6 months and includes:

1. Document Preparation: Compile manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016, CE Certificate, DMF, PMF, Wholesale License, and Company Constitution.
2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
3. Departmental Review: CDSCO reviews the submitted documents and may raise queries.
4. License Grant: Upon satisfactory review, the MD15 import license is issued.

Import fees vary by device class: for Class D devices, fees are $3000 per site plus$1500 per product.

Explore our Import License Guide for more details.

Timeline and Processing Duration

Import license processing typically takes 5 to 6 months.

Government Fees and Costs

Note: Fees are subject to change, and early budget allocation is recommended.

Common Challenges and Solutions

Challenge: Delays due to incomplete or inaccurate documentation.

Solution: Engage regulatory experts early for document review; use checklists tailored for Class D devices.

Challenge: Extended testing timelines or non-compliance in product testing.

Solution: Pre-validate test protocols with notified labs; consider pilot runs before formal testing.

Challenge: Audit non-conformities leading to license refusal.

Solution: Conduct internal mock audits; ensure QMS aligns with ISO 13485 and CDSCO expectations.

Challenge: Managing communication and queries from CDSCO.

Solution: Assign dedicated regulatory liaison for timely and structured responses.

Expert Consultation and Support

With our extensive experience assisting over 500 medical device companies, we provide end-to-end support—from initial classification to final license grant. Our services include:

• Gap analysis and readiness assessment
• Document preparation and compliance checks
• Coordination with notified bodies and testing labs
• Audit preparation and post-audit support
• Query management and follow-up with CDSCO

Our client-centric approach reduces approval time and mitigates risks of rejection.

Getting Started with Your CDSCO License Application for Ventricular Bypass Devices

1. Confirm Device Classification: Verify your device is Class D under the latest CDSCO notifications (Medical Device Classification).
2. Engage Testing Laboratories: Schedule product testing early with CDSCO-approved labs (Testing Laboratories).
3. Prepare Documentation: Initiate Device and Plant Master File development immediately using industry best practices.
4. Apply for Test License (MD13): Submit your test license application on the CDSCO MD Online Portal to begin sample manufacturing.
5. Plan Facility Readiness: Ensure your manufacturing site complies fully with regulatory and safety standards ahead of audit.
6. Consult Experts: Partner with seasoned regulatory consultants to navigate complex regulatory pathways efficiently.

By proactively addressing these steps, manufacturers and importers can streamline their journey towards obtaining the mandatory CDSCO MD9 or MD15 licenses for ventricular bypass (assist) devices, ensuring timely market entry and compliance with Indian regulations.

For personalized assistance or detailed queries, feel free to reach out to our regulatory consultancy team.