CDSCO License for Endolymphatic Shunt Tube

Comprehensive Guide to CDSCO Licensing for Endolymphatic Shunt Tube (Class B Catheter)

With over 25 years of regulatory expertise supporting 500+ medical device manufacturers, we understand the complexities involved in obtaining CDSCO licenses in India. The Endolymphatic Shunt Tube, classified as a Class B medical device under catheter category, requires compliant and timely regulatory approvals to enter the Indian market.

Introduction: Endolymphatic Shunt Tube and Its Regulatory Importance

The Endolymphatic Shunt Tube is a specialized catheter used during surgical procedures to place in the membranous labyrinth of the inner ear, facilitating drainage of excess fluid and managing inner ear disorders. Given its invasive use and patient safety implications, the Central Drugs Standard Control Organization (CDSCO) mandates strict regulatory compliance to ensure quality, safety, and performance.

Navigating the CDSCO licensing process for such devices is critical for manufacturers and importers aiming to commercialize this device in India.

CDSCO Regulatory Framework for Endolymphatic Shunt Tube

Since this device is notified under Notification Number 29/Misc/3/2017-DC (292) dated 06.06.2018, it falls under the purview of medical device regulations governed by CDSCO. The regulatory framework involves classification based on risk, testing, audits, and submission of detailed documentation before obtaining manufacturing or import licenses.

Risk Classification and License Requirements for Endolymphatic Shunt Tube

The Endolymphatic Shunt Tube is classified as a Class B device — low to moderate risk — under the catheter category. Accordingly, the required manufacturing license is the MD5 license, granted by the State Licensing Authority.

For importers, the corresponding license is the MD15 import license, issued by the Central Licensing Authority.

Manufacturing License Process for Class B Devices (MD5 License)

The MD5 license process involves several steps:

1. Test License Application (Form MD13): Initially, apply for a test license which takes approximately 1.5 to 2 months to be granted. This allows product testing in government-approved laboratories.

2. Product Testing: Conduct mandatory testing of the Endolymphatic Shunt Tube at CDSCO-recognized laboratories. Testing ensures compliance with applicable standards.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System documents.

4. License Application (Form MD3): Submit the manufacturing license application for MD5 through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts a thorough audit of the manufacturing facility and quality systems. Find the list of notified bodies here.

6. Query Resolution: Address any queries or clarifications raised by the licensing authority or notified body.

7. License Grant: Upon satisfactory compliance, the State Licensing Authority grants the MD5 manufacturing license on Form MD5.

Manufacturing License Documents Required for Endolymphatic Shunt Tube

• Company Constitution documents
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) – detailing design, specifications, raw materials, manufacturing process (Learn more about DMF)
• Plant Master File (PMF) – describing manufacturing facility, equipment, quality controls (PMF guide here)
• Essential Principles Checklist aligned with Indian regulations
• Risk Management File documenting hazard identification and mitigation (Risk Management insights)
• Product Test Reports from CDSCO-approved labs (Approved testing labs)
• Labels and Instructions for Use (IFU)
• Quality Management System documentation, typically ISO 13485:2016 compliance evidence

Import License Process (MD15 License) for Endolymphatic Shunt Tube

For importers, the process is centralized and includes the following steps:

1. Document Preparation: Compile all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 and CE Certificates, Device and Plant Master Files, and Wholesale License.

2. Application Submission: File the application using Form MD14 via the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any queries raised by the CDSCO.

4. License Issuance: The Central Licensing Authority grants the MD15 import license.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate
• Device and Plant Master Files
• Wholesale License
• Company Constitution documents

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3 to 4 months total, including test license issuance (1.5-2 months), product testing, audit, and final license grant.
• MD15 Import License: Typically requires 5 to 6 months from application to license issuance.

Government Fees and Costs for Endolymphatic Shunt Tube Licensing

• MD5 License (Class B):

  • Application fee: Rs 5,000
  • Per product fee: Rs 500

• MD15 Import License (Class B):

  • Site fee: USD 2,000
  • Per product fee: USD 1,000

These fees are payable online during application submission on the CDSCO portal.

Common Challenges and Solutions

Challenge: Delays in product testing due to limited slots at government-approved labs.

Solution: Pre-book testing dates early and consider multiple approved labs to avoid bottlenecks.

Challenge: Incomplete or inconsistent documentation leading to multiple rounds of queries.

Solution: Engage experienced regulatory consultants to prepare and review documents meticulously before submission.

Challenge: Audit non-compliance, especially in quality management systems.

Solution: Conduct internal audits and gap analyses prior to notified body audits to ensure readiness.

Expert Consultation and Support

Given the complexity of CDSCO regulations and frequent updates, partnering with a seasoned regulatory consultant can expedite your licensing process. Our 25+ years of experience and successful track record in obtaining MD5 and MD15 licenses for Class B devices like Endolymphatic Shunt Tubes can help you avoid costly delays and compliance pitfalls.

Getting Started with Your CDSCO License Application for Endolymphatic Shunt Tube

1. Assess Your Device Classification: Confirm your device is Class B and eligible for MD5 license.
2. Prepare Initial Documentation: Begin compiling your Device Master File, Plant Master File, and QMS documents.
3. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal to initiate product testing.
4. Schedule Product Testing: Coordinate with CDSCO-approved labs to conduct mandatory tests.
5. Plan for Audit: Engage a notified body early and prepare your facility and documentation for the audit.
6. Submit Manufacturing License Application (Form MD3): After successful testing and audit readiness.
7. Respond Promptly to Queries: Maintain active communication with authorities to resolve any questions quickly.

Embarking on your licensing journey with a clear roadmap and expert guidance is key to successful market entry. Contact us today to leverage our proven expertise and streamline your CDSCO license acquisition for the Endolymphatic Shunt Tube.