CDSCO License for Gastric, Colonic, etc.) Irrigation and Aspiration  Catheter

Comprehensive Guide to CDSCO Licensing for Gastric, Colonic, and Related Irrigation and Aspiration Catheters

The Gastric and Colonic Irrigation and Aspiration Catheter is a specialized medical device used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding within the alimentary tract. Classified as a Class B medical device, it requires a meticulous regulatory process to ensure safety, quality, and compliance before entering the Indian market. As seasoned regulatory consultants with over 25 years of experience assisting 500+ companies, we provide you with a detailed roadmap to navigate the CDSCO licensing requirements efficiently.

CDSCO Regulatory Framework for Catheters

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India under the Medical Device Rules, 2017. Catheters like Gastric and Colonic Irrigation and Aspiration Catheters fall under the category specified in notification number 29/Misc/3/2017-DC (292) dated 06.06.2018.

For Class B devices, the licensing authority is the State Licensing Authority, and the applicable manufacturing license is the MD5 License. This framework ensures that devices meet strict quality and safety standards through audits, tests, and rigorous documentation.

Risk Classification and License Requirements for Class B Catheters

Class B devices represent low to moderate risk. According to CDSCO classification, your catheter is a Class B device requiring:

• Manufacturing License: MD5 License (Application Form MD3)
• Test License: MD13 (mandatory before applying for MD5)
• Audit: By a notified body

You can review detailed classification guidelines in our Medical Device Classification resource.

Manufacturing License Process (MD5) for Gastric and Colonic Catheters

The manufacturing license process for Class B devices involves several key steps:

1. Test License Application (Form MD13): Submit through the CDSCO MD Online Portal. This license permits product testing.
2. Product Testing: Conducted at CDSCO-approved laboratories listed on the Testing Laboratories page.
3. Document Preparation: Compile required documents including Device Master File, Plant Master File, risk management and quality systems.
4. Application for MD5 License (Form MD3): Submit after successful testing.
5. Audit by Notified Body: Performed by entities found in the Notified Bodies List for MD5 Audit.
6. Query Resolution: Address any queries raised by the licensing authority or notified body.
7. Grant of MD5 License (Form MD5): Upon satisfactory completion of all steps.

Manufacturing License Documents Required for Class B Devices

Manufacturers must submit comprehensive documentation, including but not limited to:

• Company Constitution and Ownership Proof
• Ownership/Lease Documents of Manufacturing Premises
• Details and Credentials of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device design, specifications, and compliance (Device Master File Guide)
• Plant Master File (PMF): Facility layout, equipment, and quality control systems (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved testing laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process for Gastric and Colonic Catheters (MD15)

For importers of this Class B catheter device, an MD15 License granted by the Central Licensing Authority is mandatory. The process includes:

• Document compilation including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files
• Application submission via the CDSCO MD Online Portal
• Departmental query resolution
• License grant on Form MD15

This license typically takes 5–6 months, reflecting the rigorous evaluation of imported medical devices.

Import License Documents Required

Importers must prepare the following documents:

• Valid Manufacturing License of the device
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Mark certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License
• Company constitution and ownership proofs

Timeline and Processing Duration

Our experience shows that proactive document preparation and early engagement with notified bodies significantly reduce delays.

Government Fees and Costs

For manufacturing MD5 licenses pertaining to Class B devices:

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs include:

• Testing fees at government-approved laboratories
• Audit fees charged by notified bodies

For import licenses (MD15), fees vary by class but for Class B devices, expect approximately:

• $2,000 per site
• $1,000 per product

Budget accordingly to avoid bottlenecks during licensing.

Common Challenges and Practical Solutions

• Incomplete Documentation: Missing or inconsistent data is the leading cause of application rejection. Use a thorough checklist and consult our Device Master File Guide to ensure completeness.

• Delays in Testing: Select CDSCO-approved testing labs well in advance and confirm their lead times. Early scheduling helps adhere to timelines.

• Audit Non-Compliance: Prepare your facility and QMS rigorously; conduct internal audits before notified body visits.

• Query Resolution Delays: Respond promptly and clearly to queries raised by CDSCO or notified bodies to avoid process stoppage.

Expert Consultation and Support

Having supported over 500 medical device companies, we understand the nuances of CDSCO licensing for Class B devices like Gastric and Colonic Irrigation and Aspiration Catheters. Our services include:

• Gap analysis for your documentation and processes
• End-to-end application preparation and submission
• Coordination with notified bodies and testing labs
• Regulatory strategy and compliance training

Engaging expert consultants can dramatically reduce your time-to-market and prevent costly compliance issues.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device classification as Class B using authoritative resources.
2. Prepare Documentation: Begin compiling your Device Master File, Plant Master File, and QMS documents.
3. Apply for Test License (MD13): Submit via the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with CDSCO-approved laboratories early.
5. Engage a Notified Body: Identify and liaise with notified bodies from the Notified Bodies List.
6. Submit Manufacturing License Application (MD5): After successful testing, apply for your manufacturing license.
7. Prepare for Audit and Query Resolution: Maintain readiness for inspections and promptly address all queries.

By following this structured approach and leveraging our expertise, manufacturers and importers can efficiently obtain CDSCO licenses for Gastric, Colonic, and related Irrigation and Aspiration Catheters, ensuring compliance and market access in India.

For personalized guidance or to initiate your application, contact us today and leverage our 25+ years of proven regulatory success.