CDSCO License for Jejunostomy  Catheter

Comprehensive CDSCO Licensing Guide for Jejunostomy Catheter (Class B)

Jejunostomy catheters are critical medical devices used for intraoperative feeding jejunostomy, enabling direct nutritional support to patients unable to take oral feeds. Classified under Catheters and notified via 29/Misc/3/2017-DC (292) dated 06.06.2018, these devices fall within Class B risk category under CDSCO regulations in India. For manufacturers and importers aiming to enter the Indian market, understanding the detailed regulatory framework and licensing requirements is essential to ensure compliance and smooth market access.

With over 25 years of experience and having supported 500+ companies in navigating CDSCO licensing, we offer you a clear roadmap covering timelines, costs, documentation, and practical tips specifically for the Jejunostomy catheter.

CDSCO Regulatory Framework for Jejunostomy Catheter

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Jejunostomy catheters are categorized as Class B devices, which are considered low to moderate risk. The regulatory oversight for Class B devices mandates obtaining an MD5 manufacturing license issued by the State Licensing Authority.

To comply with the regulatory framework, manufacturers must fulfill requirements including product testing, quality management system implementation, documentation submission, and facility audits. The entire process aims to ensure product safety, efficacy, and adherence to Indian Medical Device Rules 2017.

Risk Classification and License Requirements for Jejunostomy Catheter

• Device: Jejunostomy Catheter
• Risk Class: B (Low to moderate risk)
• Intended Use: Intraoperative feeding jejunostomy
• CDSCO License Type: MD5 Manufacturing License
• Application Form: MD3
• Licensing Authority: State Licensing Authority

Class B devices like Jejunostomy catheter require the MD5 license, which involves obtaining a test license (Form MD13) initially, conducting testing through CDSCO-approved labs, followed by audits from notified bodies before final license approval.

Manufacturing License Process (MD5) for Jejunostomy Catheter

The MD5 license process for Jejunostomy catheter broadly includes the following steps:

1. Apply for Test License (Form MD13): This prerequisite license allows product testing in notified government laboratories. The processing time is approximately 1.5 to 2 months.

2. Product Testing: Testing must be conducted at CDSCO-approved labs to verify compliance with essential safety and performance standards. Refer to the list of testing laboratories for appropriate facilities.

3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and others (detailed below).

4. Application Submission (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body listed here conducts a facility audit and reviews quality systems.

6. Resolution of Queries: Address any deficiencies or queries raised by the licensing authority or notified body promptly.

7. Grant of License (Form MD5): Upon successful audit and document verification, the MD5 manufacturing license is issued.

Manufacturing License Documents Required for Jejunostomy Catheter

To ensure a smooth licensing process, prepare the following documents meticulously:

• Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association
• Proof of Ownership/Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device description, specifications, manufacturing process. Our comprehensive Device Master File guide can assist you.
• Plant Master File (PMF): Manufacturing facility layout, equipment details, quality control processes. Refer to our Plant Master File guide for preparation tips.
• Essential Principles Compliance Checklist
• Risk Management File: Hazard analysis, risk control measures. See best practices in our Risk Management resource.
• Test Reports from CDSCO-approved Labs
• Labels, Packaging, and Instructions for Use (IFU)
• Quality Management System Documents: ISO 13485 certification and internal SOPs

Import License Process (MD15) for Jejunostomy Catheter

For importers intending to bring Jejunostomy catheters into India, an MD15 import license is mandatory. The process includes:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution.
• Application submission on the CDSCO MD Online Portal.
• Review and queries resolution by CDSCO Central Licensing Authority.
• Grant of MD15 license typically in 5-6 months.

Importers must note that unlike manufacturing, a test license is not required.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (State Authority)
• Company Constitution Documents

Timeline and Processing Duration for Jejunostomy Catheter License

This timeline assumes proactive documentation and prompt response to queries, which we strongly advise to keep delays minimal.

Government Fees and Costs for Jejunostomy Catheter License

• MD5 License Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs include:

• Testing laboratory charges (varies by lab and tests required)
• Fees for notified body audit (typically Rs 40,000 – Rs 60,000 depending on scope)
• Internal costs for document preparation and consultancy

For import licenses (MD15), fees are higher and centrally regulated; consult detailed guides for exact fee schedules.

Common Challenges and Practical Solutions

• Delayed Testing Reports: Engage with CDSCO-approved labs early and confirm test turnaround times to avoid bottlenecks.
• Incomplete Documentation: Use detailed checklists and standardized templates to ensure all documents meet CDSCO expectations.
• Audit Non-conformities: Prepare thoroughly for facility audits by conducting internal mock audits and training staff.
• Query Resolution Delays: Assign a dedicated regulatory expert to respond promptly and comprehensively to departmental queries.

Our extensive experience allows us to preempt these issues and guide clients effectively through the process.

Expert Consultation and Support

Navigating CDSCO licensing for Jejunostomy catheters can be complex. With our proven track record and deep understanding of regulatory nuances, we provide:

• End-to-end application preparation
• Device and plant master file development
• Test license and product testing coordination
• Notified body audit management
• Query handling and compliance support

Leverage our expertise to accelerate your market entry and maintain compliance.

Getting Started with Your CDSCO License Application

To initiate your MD5 license application for Jejunostomy catheters, follow these actionable steps:

1. Register on the CDSCO MD Online Portal to create your company profile.
2. Apply for the Test License (Form MD13) to enable product testing.
3. Identify CDSCO-approved testing laboratories and schedule sample testing.
4. Prepare your Device and Plant Master Files using our comprehensive guides.
5. Compile all required documentation including QMS and risk management files.
6. Submit your MD5 application (Form MD3) online after receiving test reports.
7. Coordinate with a notified body for the mandatory facility audit.
8. Respond promptly to any queries from CDSCO or the notified body.

Starting early and following this structured approach will help you secure your manufacturing license within the stipulated timeframe.

For personalized assistance, please contact our regulatory experts who have successfully supported over 500 companies in medical device licensing across India.

By adhering to these guidelines and leveraging expert support, manufacturers and importers can confidently navigate the CDSCO licensing process for Jejunostomy catheters, ensuring timely compliance and market readiness.