CDSCO License for Oesophageal Blakemore Tube

Introduction to Oesophageal Blakemore Tube and Its Regulatory Importance

The Oesophageal Blakemore Tube is a critical medical device used in the emergency management of upper gastrointestinal hemorrhage caused by oesophageal varices. Inserted through the nose or mouth, this catheter-type device plays a life-saving role in controlling bleeding. Due to its invasive nature and potential risk to patients, regulatory compliance under the Central Drugs Standard Control Organisation (CDSCO) is mandatory before manufacturing or importing this device into the Indian market.

With over 25 years of experience assisting 500+ companies in navigating CDSCO licensing, we understand the nuances of securing approvals for such medical devices. This comprehensive guide focuses on the regulatory pathway for the Oesophageal Blakemore Tube, classified as a Class B medical device, detailing the license requirements, timelines, costs, and practical tips to ensure a smooth approval process.

CDSCO Regulatory Framework for Oesophageal Blakemore Tube

The CDSCO classifies medical devices based on risk, intended use, and invasiveness. The Oesophageal Blakemore Tube falls under Class B (low moderate risk) devices as per the notification 29/Misc/3/2017-DC (292) dated 06.06.2018, categorized under catheters.

Manufacturers of Class B devices must obtain an MD5 manufacturing license issued by the State Licensing Authority. This ensures compliance with quality management systems, safety standards, and performance criteria outlined by CDSCO and other relevant guidelines.

Risk Classification and License Requirements

• Device Risk Class: B (Low Moderate Risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Issuing Authority: State Licensing Authority
• Process Duration: Approximately 3 to 4 months
• Fees: Rs 5,000 per application + Rs 500 per product

The MD5 license process is rigorous and includes obtaining a Test License (MD13), product testing from CDSCO-approved laboratories, documentation, audit by notified bodies, and resolution of regulatory queries.

Manufacturing License Process for Oesophageal Blakemore Tube (MD5)

1. Obtain Test License (MD13): Begin by applying for a Test License through Form MD13 on the CDSCO MD Online Portal. This license permits you to manufacture the device for testing purposes and typically takes 1.5 to 2 months to be granted.

2. Product Testing: After receiving the Test License, submit samples of the Oesophageal Blakemore Tube to CDSCO-approved testing laboratories. You can refer to the list of testing laboratories to select an accredited lab. Testing can take 4-6 weeks depending on lab workload.

3. Documentation Preparation: Simultaneously, prepare all required technical and quality documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Application for Manufacturing License (MD5): Submit your application using Form MD3 on the CDSCO MD Online Portal. Include all documents, test reports, and fees.

5. Audit by Notified Body: A notified body, selected from the official list of notified bodies, will conduct a thorough audit of your manufacturing facility and QMS.

6. Resolution of Queries: Address any queries or observations raised by the notified body or CDSCO within stipulated timelines to avoid delays.

7. Grant of License: Upon satisfactory audit and document review, CDSCO grants the MD5 license in Form MD5, allowing full-scale manufacturing.

Manufacturing License Documents Required for Class B Devices

• Company Constitution (e.g., MOA, AOA)
• Proof of ownership or lease of manufacturing premises
• Qualification and experience documents of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, materials, and manufacturing process (DMF guide)
• Plant Master File (PMF) describing infrastructure and equipment (PMF guide)
• Essential Principles Checklist ensuring compliance with Indian regulations
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Device labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Oesophageal Blakemore Tube

For importers, an MD15 license issued by the Central Licensing Authority is mandatory. The process involves:

• Submission of application via Form MD14 on the CDSCO MD Online Portal
• Document review including Manufacturing License, Free Sale Certificate, ISO and CE certificates, Device and Plant Master Files, Wholesale License
• Resolution of queries
• License grant in Form MD15

The MD15 license process typically takes 5 to 6 months. Fees vary based on risk class and product quantity.

Import License Documents Required

• Valid Manufacturing License of the exporting company
• Free Sale Certificate from country of origin
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

Import license timelines extend up to 5-6 months due to central authority processing.

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Fees included in application processing
• Import License (MD15): Varies by class, typically USD 1,000+ per site plus product fees

Additional costs include lab testing fees, notified body audit charges (variable), and consultancy fees if external support is engaged.

Common Challenges and Solutions

Challenge: Delays in test license grant or product testing

Solution: Initiate test license application early and pre-select testing labs with shorter turnaround times.

Challenge: Non-compliance during audit

Solution: Conduct pre-audit internal assessments, ensure robust QMS, and maintain clear documentation.

Challenge: Incomplete or inconsistent documentation

Solution: Use standardized templates for Device Master Files and Plant Master Files; consult expert resources like our Device Master File guide.

Challenge: Managing regulatory queries

Solution: Respond promptly and thoroughly with supporting evidence; maintain communication with CDSCO officers.

Expert Consultation and Support

Navigating CDSCO licensing for Class B devices like the Oesophageal Blakemore Tube requires detailed knowledge of regulatory expectations and administrative processes. We provide end-to-end consultancy—from document preparation, audit readiness, to application submission and follow-up. Our experience with over 500 companies ensures that your licensing journey is efficient and compliant.

Getting Started with Your CDSCO License Application for Oesophageal Blakemore Tube

1. Assess Device Classification: Confirm Class B status using the Medical Device Classification tool.

2. Register on CDSCO MD Online Portal: Create your account and familiarize yourself with the portal navigation at CDSCO MD Online Portal.

3. Prepare Documentation: Begin compiling your Device Master File, Plant Master File, Risk Management File, and supporting certificates.

4. Apply for Test License (MD13): Submit your application early to avoid downstream delays.

5. Schedule Product Testing: Contact CDSCO-approved labs listed on the portal to arrange timely testing.

6. Engage a Notified Body: Select a notified body for your facility audit from the official list of notified bodies.

7. Plan Audit and Internal Review: Conduct internal mock audits to identify and rectify gaps.

8. Submit MD5 License Application: Once testing and documentation are complete, apply for the MD5 license.

9. Monitor Application Status: Regularly check the portal and resolve queries promptly.

By following these practical steps and leveraging our regulatory expertise, manufacturers of the Oesophageal Blakemore Tube can confidently enter the Indian market with full compliance and minimal delays.