CDSCO License for A-V Shunt or Fistula Adapter

Comprehensive Guide to CDSCO Licensing for A-V Shunt or Fistula Adapter (Class B Catheter)

As specialists with over 25 years of experience in medical device regulatory consulting, having supported 500+ companies in successfully securing CDSCO licenses, we understand the nuances involved in navigating India’s regulatory framework. This guide focuses on the A-V Shunt or Fistula Adapter, a Class B blood access catheter device, intended primarily for haemodialysis or other chronic vascular access uses.

Understanding the A-V Shunt or Fistula Adapter and Its Regulatory Importance

An A-V Shunt or Fistula Adapter facilitates repeated vascular access, critical for patients undergoing haemodialysis. Given its direct contact with the bloodstream and chronic use scenario, it falls under Class B risk classification as per CDSCO guidelines. Proper regulatory approval ensures not only market access but also patient safety and compliance with India’s Medical Device Rules (MDR), 2017.

CDSCO Regulatory Framework for Class B Catheters

Medical devices in India are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. The Medical Device Rules, 2017 classify devices from Class A (low risk) to Class D (high risk). Class B devices like the A-V Shunt require a manufacturing license known as the MD5 license, issued by the State Licensing Authority.

Risk Classification and License Requirements for A-V Shunt or Fistula Adapter

• Device Name: A-V Shunt or Fistula Adapter
• Risk Class: B (Moderate risk)
• Category: Catheters
• Notification Number: 29/Misc/3/2017-DC (292)
• Notification Date: 06.06.2018

Class B devices demand rigorous compliance including testing, documentation, and audits to ensure safety and efficacy.

Manufacturing License Process (MD5) for Class B Devices

The licensing journey begins with obtaining a Test License (Form MD13), followed by product testing at government-approved laboratories, document preparation, application submission (Form MD3), an audit by a notified body, and finally, license grant (Form MD5). The entire process typically spans 3 to 4 months.

Step-by-step process:

1. Apply for Test License (MD13): This initial step takes approximately 1.5 to 2 months and permits sample testing.
2. Product Testing: Conducted at CDSCO-approved labs (Testing Laboratories List), results must meet Indian standards.
3. Document Compilation: Prepare comprehensive technical files including Device Master File and Plant Master File.
4. Submit Manufacturing License Application (MD3): File electronically via the CDSCO MD Online Portal.
5. Audit by Notified Body: Select from the Notified Bodies List for ISO and QMS audits.
6. Respond to Queries: Address any departmental or audit observations promptly.
7. License Grant: Upon satisfactory compliance, MD5 license is issued.

Manufacturing License Documents Required for A-V Shunt or Fistula Adapter

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Rent Agreement of Manufacturing Premises
• Details of Qualified Technical Staff
• Fire and Pollution NOCs
• Device Master File (DMF) – covering design, manufacturing process, and safety data (Device Master File Guide)
• Plant Master File (PMF) – facility details, quality systems (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File (including hazard analysis and mitigation strategies) (Risk Management)
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485:2016 preferred)

Import License Process (MD15) for A-V Shunt or Fistula Adapter

If you are an importer aiming to bring the A-V Shunt or Fistula Adapter into India, the MD15 Import License is mandatory. This license is issued by the CDSCO Central Licensing Authority and typically takes 5 to 6 months.

Key Steps:

• Compile required documents including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate.
• Submit application on the CDSCO MD Online Portal.
• Respond to departmental queries.
• Await license grant.

Import License Documents Required

• 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 License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

Government Fees and Costs for A-V Shunt (Class B)

• MD5 License: Rs 5,000 (application) + Rs 500 per product
• Test License (MD13): Included in MD5 process

For imports under MD15:

• Class B: Approximately Rs 1,50,000 (site fee) + Rs 75,000 per product (converted approx from USD $2000 +$1000)

These fees are subject to change; always verify on the official CDSCO portal.

Common Challenges and Solutions for Class B Devices

• Incomplete Documentation: Missing Device or Plant Master Files often delay approval. Early preparation following our Device Master File guide can prevent this.
• Testing Delays: Testing capacity at notified labs can be limited; plan sample submissions early.
• Audit Non-Compliance: Engaging experienced notified bodies and performing internal audits beforehand is critical.
• Query Resolution: Timely, clear responses backed by evidence expedite license grants.

Expert Consultation and Support

With extensive experience guiding over 500 manufacturers and importers, our regulatory consulting services encompass:

• Gap analysis and readiness assessment
• Complete dossier preparation
• Coordination with notified bodies and testing labs
• Representation during audits and inspections
• Query management and post-approval support

Getting Started with Your CDSCO License Application for A-V Shunt

1. Identify Device Classification: Confirm Class B status and applicable notifications.
2. Prepare Test Samples: Ensure conformity to Indian standards.
3. Apply for Test License (MD13): Submit on the CDSCO MD Online Portal to initiate testing.
4. Engage a Notified Body: Select from the official list early to schedule audits.
5. Gather Documentation: Use our guides to compile comprehensive Device and Plant Master Files.
6. Submit Application for MD5 License: Post successful testing and document readiness.
7. Respond to Queries Promptly: Maintain clear communication with CDSCO.

Embarking on your CDSCO licensing journey for the A-V Shunt or Fistula Adapter requires strategic planning and adherence to regulatory nuances. We stand ready to assist you at each step to ensure a smooth, compliant, and timely market entry.

For more detailed insights and personalized support, connect with our experts to streamline your regulatory pathway.