CDSCO License for Oesophageal Sengtaken Tube

Comprehensive Guide to CDSCO License for Oesophageal Sengstaken Tube (Class B Catheter)

Navigating the regulatory landscape for medical devices in India can be complex, especially for niche yet critical devices like the Oesophageal Sengstaken Tube. As an emergency-use catheter designed to control bleeding from esophageal varices when medication alone is insufficient, this device falls under Risk Class B according to CDSCO classification.

With over 25 years of expertise and having supported 500+ companies through the licensing maze, we provide a detailed, actionable guide to securing your CDSCO MD5 Manufacturing License for the Oesophageal Sengstaken Tube.

Understanding the Device and Its Regulatory Importance

The Oesophageal Sengstaken Tube is a lifesaving catheter used exclusively in emergencies to manage bleeding varices, a condition with high mortality risk. Given its critical role and moderate risk profile, CDSCO classifies it as a Class B medical device, requiring stringent regulatory oversight to ensure safety and efficacy.

Proper CDSCO licensing is not just a legal necessity but a trust signal to healthcare providers and patients, ensuring your device meets Indian standards for quality and performance.

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 & Family Welfare. For Class B devices like the Oesophageal Sengstaken Tube, the manufacturing license is governed by the Drugs and Cosmetics Act, 1940 and Rules, 1945, specifically under the Medical Devices Rules, 2017.

Manufacturers must obtain a MD5 license issued by the State Licensing Authority to legally manufacture and market this device in India.

Risk Classification and Licensing Requirements

• Device Name: Oesophageal Sengstaken Tube
• Category: Catheters
• Risk Class: B (Moderate risk)
• Notification: 29/Misc/3/2017-DC (292), dated 06.06.2018

Class B devices require an MD5 license (application on Form MD3) from the State Authority. This license process includes a mandatory test license, product testing, and audit from a notified body.

Step-by-Step Manufacturing License Process (MD5)

1. Obtain Test License (Form MD13): Before full manufacturing approval, the company must secure a test license. This permits manufacturing limited quantities for testing purposes.
2. Product Testing: Conduct tests at CDSCO-approved government laboratories to validate safety and performance. You can check the list of testing laboratories authorized for this purpose.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documents.
4. Application Submission: Submit the manufacturing license application on Form MD3 via the CDSCO MD Online Portal.
5. Audit by Notified Body: Arrange an audit by a CDSCO-approved notified body. Refer to the notified bodies list to select an auditor.
6. Queries and Compliance: Respond promptly to any queries or observations from CDSCO or the notified body.
7. License Grant: Once all requirements are met, the license is granted on Form MD5.

Essential Documents Required for MD5 License

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification & Experience Details
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, manufacturing process, and specifications (Device Master File Guide)
• Plant Master File (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File demonstrating hazard analysis and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU) compliant with CDSCO guidelines
• Quality Management System (QMS) documentation aligned with ISO 13485

Import License Process (MD15) Overview

While this guide focuses on manufacturing, importers of Oesophageal Sengstaken Tubes require an MD15 license granted by the Central Licensing Authority. This process generally takes 5-6 months and requires:

• Valid Manufacturing License
• Free Sale Certificate from country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device and Plant Master Files
• Wholesale License
• Company Constitution

For import-specific guidance, see our Import License Guide.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 4 weeks depending on lab backlog
• Audit and Inspection: 1 month
• Final License (MD5) Grant: 3 to 4 months total from application submission

Manufacturers should anticipate a total duration of approximately 3-4 months from test license to full manufacturing license.

Government Fees and Costs

• Test License (MD13): Included in application fees or nominal charges
• MD5 License (Form MD3):
  • Rs. 5,000 per application
  • Rs. 500 per product
• Testing Charges: Variable; typically Rs. 50,000 to Rs. 1,00,000 per product test
• Audit Fees: Charged by notified body (varies; approx Rs. 50,000 to Rs. 1,00,000)

Budgeting for these expenses upfront can prevent delays and compliance issues.

Common Challenges and Expert Solutions

• Delayed Product Testing: Labs can have long queues; early scheduling and pre-submission can expedite this.
• Incomplete Documentation: Use comprehensive checklists and templates to avoid rejections.
• Audit Non-Compliance: Conduct pre-audit internal assessments and train staff thoroughly.
• Query Resolution Delays: Designate a dedicated regulatory liaison for swift communication.

Our experience shows that proactive planning and expert support are key to overcoming these hurdles.

Expert Consultation and Support

Navigating CDSCO licensing for a specialized device like the Oesophageal Sengstaken Tube demands regulatory expertise. We offer tailored consultancy services including:

• Document preparation and review
• Pre-audit readiness
• Liaison with CDSCO and notified bodies
• Gap analysis and compliance strategy

Our proven track record with over 500 successful licenses ensures your application is in capable hands.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal to create your company profile.
2. Initiate the Test License (MD13) application to start controlled manufacturing for testing.
3. Schedule product testing at a CDSCO-approved lab.
4. Prepare your Device and Plant Master Files along with QMS and Risk Management documentation.
5. Submit your MD5 license application (Form MD3) via the portal.
6. Coordinate audit scheduling with a notified body.
7. Respond promptly to any CDSCO or audit queries.

Starting early and following this structured approach will position you for a smooth licensing journey, enabling timely market entry for your life-saving Oesophageal Sengstaken Tube.

For personalized assistance, do not hesitate to contact our regulatory experts to discuss your project requirements and timeline.

Empower your medical device business with trusted, compliant CDSCO licensing. Let's make healthcare safer together.