CDSCO License for Biliary stents

Comprehensive Guide to CDSCO Licensing for Biliary Stents (Class C Catheters)

Introduction: Understanding Biliary Stents and Regulatory Importance

Biliary stents are critical medical devices designed to facilitate bile drainage from the gallbladder, pancreas, and bile ducts into the duodenum. They are commonly used in clinical scenarios like ascending cholangitis caused by obstructing gallstones. Given their invasive nature and direct contact with internal body systems, biliary stents are classified as Class C devices under the Indian regulatory framework, reflecting a moderate-to-high risk level.

For manufacturers and importers aiming to enter the Indian market, obtaining the appropriate license from the Central Drugs Standard Control Organization (CDSCO) is non-negotiable. This ensures compliance with safety, efficacy, and quality standards mandated by Indian law, protecting patients and healthcare professionals alike.

CDSCO Regulatory Framework for Biliary Stents

The CDSCO regulates medical devices in India under the Medical Device Rules (MDR) 2017, which came into force on January 1, 2018. Biliary stents fall under the catheter category and are notified under the reference number 29/Misc/3/2017-DC (292), dated 06.06.2018.

Since biliary stents are Class C devices, the licensing authority is the Central Licensing Authority (CLA) of CDSCO. The relevant license type is the MD9 manufacturing license for Class C and D devices.

Risk Classification and License Requirements for Biliary Stents

• Risk Class: C (Moderate to High Risk)
• License Type: MD9 (Form MD7)
• Licensing Authority: Central Licensing Authority (CDSCO HQ, New Delhi)
• Applicable Rules: Medical Device Rules 2017

Class C devices like biliary stents require rigorous testing, quality management systems, and audits due to their invasive nature and potential impact on patient safety.

Manufacturing License Process for Biliary Stents (MD9 License)

The MD9 license process is a comprehensive multi-step procedure:

1. Test License Application (Form MD13): Before applying for full production, manufacturers must obtain a test license. This allows production of limited quantities for testing purposes.
2. Product Testing: Samples must be tested at CDSCO-approved government laboratories to ensure compliance with Indian standards. You can refer to the list of testing laboratories for authorized facilities.
3. Document Preparation: Compile all mandatory documents, including technical dossiers and quality management system records.
4. Application Submission (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal with the required fees.
5. Audit by CDSCO Inspectors: CDSCO conducts a detailed audit of manufacturing facilities and documentation.
6. Query Resolution: Address any queries or observations raised by the inspectors or the review committee.
7. Grant of Manufacturing License (Form MD9): Upon satisfactory compliance, the license is granted, allowing commercial manufacturing.

Manufacturing License Documents Required for MD9

For biliary stents, the documentation must be thorough and accurate. Key documents include:

• Company Constitution Documents: Incorporation certificates, partnership deeds, or trust deeds
• Proof of Ownership/Lease of Manufacturing Premises: Valid legal documents confirming premises
• Technical Staff Documents: CVs, qualification certificates, and experience proofs of qualified personnel
• Fire NOC and Pollution Control Certificates: Compliances with local safety and environmental norms
• Device Master File (DMF): Detailed design, manufacturing process, and validation data. Our Device Master File guide offers a step-by-step approach.
• Plant Master File (PMF): Details of manufacturing facilities, utilities, and equipment. Refer to our Plant Master File Guide for preparation tips.
• Essential Principles Checklist: Demonstrates compliance with Indian Essential Principles of Safety and Performance
• Risk Management File: Comprehensive risk analysis and mitigation plans following ISO 14971 principles. See our Risk Management guide for insights.
• Test Reports: Certified lab reports for product performance and safety
• Labels and Instructions for Use (IFU): Compliance with labeling standards and clear user instructions
• Quality Management System (QMS) Documents: ISO 13485 certification, SOPs, and audit reports

Import License Process for Biliary Stents (MD15 License)

Importers wishing to bring biliary stents into India must apply for an MD15 import license from the CDSCO Central Licensing Authority. The process involves:

1. Document Preparation: Collect all essential documents including manufacturing license from the country of origin.
2. Application Submission (Form MD14): Submit the import license application via the CDSCO MD Online Portal.
3. Review and Queries: CDSCO reviews documents and may seek clarifications.
4. Grant of Import License (Form MD15): Upon clearance, the license is issued.

Import License Documents Required

• Manufacturing License of the Device Issued by the Country of Origin
• Free Sale Certificate (FSC): Certifying the product is freely sold in the country of origin
• ISO 13485:2016 Certificate: Demonstrating compliance with international QMS standards
• CE Certificate: For devices marketed in the European Union
• Device Master File and Plant Master File
• Wholesale Drug License: For importers
• Company Constitution Documents

Timeline and Processing Duration

The overall timeline for manufacturing license (MD9) for biliary stents typically ranges between 4 to 5 months. This includes the test license issuance, product testing, document submission, audit, and final approval.

Government Fees and Costs

For MD9 license applications pertaining to Class C devices like biliary stents:

• Application Fee: Rs 50,000 per application
• Per Product Fee: Rs 1,000 per product

For import licenses (MD15), fees vary by device class and number of products; expect higher fees for Class C devices.

Budgeting for professional consultation, document preparation, testing laboratory charges, and audit fees is essential for smooth processing.

Common Challenges and Solutions

• Delayed Test Reports: Testing at government-approved labs can be time-consuming. Plan early and confirm lab capacity.
• Incomplete Documentation: Missing or inconsistent documents cause prolonged queries. Use detailed checklists and pre-audit reviews.
• Audit Non-Compliance: Facilities not meeting GMP or QMS standards face rejection. Regular internal audits and staff training are vital.
• Query Management: Timely and thorough responses to CDSCO queries can prevent delays.

Expert Consultation and Support

With over 25 years of experience and 500+ successful CDSCO license applications, we provide end-to-end support—from document preparation, submission, follow-ups, to audit readiness for biliary stents and other medical devices. Our expertise ensures compliance and accelerates market entry.

Getting Started with Your CDSCO License Application for Biliary Stents

1. Assess Your Device Classification: Confirm biliary stents as Class C devices via the Medical Device Classification resource.
2. Initiate Test License (Form MD13): Submit your application on the CDSCO MD Online Portal.
3. Engage a Government-Approved Testing Laboratory: Arrange sample testing early.
4. Prepare Comprehensive Documentation: Utilize our guides on Device Master File and Plant Master File.
5. Plan for CDSCO Audit: Ensure your manufacturing site and QMS are audit-ready.
6. Submit Manufacturing License Application (Form MD7) for MD9: After successful testing and documentation.

Starting early and partnering with experienced regulatory consultants can make all the difference in navigating the CDSCO licensing landscape smoothly and successfully. Contact us today to discuss your biliary stent licensing project and benefit from our proven track record.

For more detailed insights, visit the MD9 License Guide and start your journey with confidence.