CDSCO License for Duodenal bypass liner

Comprehensive Guide to CDSCO Licensing for Duodenal Bypass Liner (Class C Medical Device)

Navigating the regulatory landscape for medical devices in India requires expertise, especially for specialized devices like the Duodenal Bypass Liner. This non-sterile, stent-like gastroenterology device is designed to reduce nutrient absorption by implantation in the duodenum, aiding obese patients in weight loss. Classified as a Class C device under CDSCO’s framework, it demands rigorous compliance to ensure market access.

With over 25 years of consulting experience and having assisted 500+ manufacturers and importers, we provide detailed insights into obtaining the necessary licenses, including practical timelines, costs, and documentation tailored specifically for this device.

CDSCO Regulatory Framework for the Duodenal Bypass Liner

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules, 2017. The Duodenal Bypass Liner falls under the gastroenterology category and is regulated as a Class C device due to its invasive nature and potential impact on physiological functions.

The relevant notification for this device is [29/Misc./03/2020-DC (182)] dated 27.09.2021, which formalizes its classification and regulatory requirements.

Manufacturers require a Central License (MD9) for production, while importers must obtain an Import License (MD15) from CDSCO.

Risk Classification and License Requirements

• Device Name: Duodenal Bypass Liner
• Risk Class: C (Moderate to high risk)
• License Type:
  • Manufacturing License: MD9 (Central Licensing Authority)
  • Import License: MD15 (Central Licensing Authority)

Class C devices are subject to stringent safety, quality, and performance standards, including mandatory product testing, audits, and comprehensive documentation.

For a full understanding of device classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD9) for Duodenal Bypass Liner

The MD9 manufacturing license is granted by the Central Licensing Authority. The process typically spans 4 to 5 months, inclusive of test license issuance, product testing, documentation, audits, and query resolution.

Stepwise Process:

1. Test License (MD13): Before applying for MD9, manufacturers must obtain a test license on Form MD13. This takes approximately 1.5 to 2 months.

2. Product Testing: The device must be tested at CDSCO-approved government laboratories. Testing can take between 4 to 6 weeks, depending on lab capacity. Manufacturers can find approved labs on the CDSCO Testing Laboratories list.

3. Documentation Preparation: Assemble comprehensive documents including technical files, Device Master File (DMF), Plant Master File (PMF), and Risk Management File.

4. Application Submission: Apply via the CDSCO MD Online Portal using Form MD7.

5. Audit by CDSCO Inspectors: Post-application, CDSCO conducts a facility audit to verify compliance.

6. Query Resolution: Address any queries raised by CDSCO during the review and audit process.

7. License Grant: Upon satisfaction, the MD9 license is issued in Form MD9.

For detailed insights, our MD9 License Guide covers all steps.

Manufacturing License Documents Required

The documentation for MD9 is extensive to ensure device safety and compliance:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process. See our Device Master File guide.
• Plant Master File (PMF) documenting manufacturing facilities and quality control. Learn more via our Plant Master File guide.
• Essential Principles Checklist demonstrating compliance with Indian standards
• Risk Management File illustrating hazard identification and mitigation strategies. For methodology, check our Risk Management guide.
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Duodenal Bypass Liner

Importers seeking to bring the Duodenal Bypass Liner into India must obtain the MD15 license from the Central Licensing Authority. This process generally takes 5 to 6 months.

Key Steps:

1. Document Preparation: Ensure all required documents are ready, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), and Device Master and Plant Master Files.

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

3. Review and Query Resolution: CDSCO reviews submissions and requests clarifications if necessary.

4. License Issuance: Upon approval, MD15 license is granted.

Our Import License Guide provides a detailed walkthrough.

Import License Documents Required

• Valid Manufacturing License from the country of manufacture
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution/Registration
• Detailed Product Information including labels and IFU

Timeline and Processing Duration

Note: These timelines may vary based on audit scheduling, query response time, and document completeness.

Government Fees and Costs

Additional costs include fees for testing labs, notified body audits, and technical consultancy if outsourced.

Common Challenges and Practical Solutions

• Delays in Product Testing: Coordinate early with approved labs and submit samples promptly. Maintain constant communication to avoid backlogs.

• Incomplete Documentation: Use standardized templates for DMF, PMF, and risk management files. Our Device Master File guide can help streamline this.

• Audit Non-Compliance: Prepare your facility and QMS thoroughly ahead of audits. Conduct internal mock audits to identify gaps.

• Query Response Delays: Assign a dedicated regulatory liaison to promptly address CDSCO queries.

Expert Consultation and Support

Given the complexity of Class C device licensing, expert guidance is invaluable. Our team has successfully supported 500+ companies in navigating the CDSCO process for devices like the Duodenal Bypass Liner. From documentation to audit readiness, we offer tailored solutions to expedite approvals and ensure compliance.

Getting Started with Your CDSCO License Application

1. Initiate Device Classification Confirmation: Verify your device’s classification and regulatory pathway.

2. Register on CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal to begin application submissions.

3. Prepare Test License Application (MD13): Start with the test license to enable product testing.

4. Engage Approved Testing Laboratories: Arrange for sample testing early to avoid delays.

5. Develop Comprehensive Documentation: Compile DMF, PMF, Risk Management, and QMS documents.

6. Schedule Audit Preparation: Prepare your facility and staff for CDSCO inspections.

7. Submit Manufacturing License Application (MD9): After fulfilling testing and documentation, apply for MD9.

8. For Importers, Prepare MD15 Application: Gather all foreign certifications and apply accordingly.

By following these actionable steps and leveraging expert support, manufacturers and importers can efficiently secure CDSCO licenses and confidently enter the Indian market with the Duodenal Bypass Liner.

For personalized assistance or to discuss your specific project, contact our regulatory consultancy team, who brings decades of success in CDSCO licensing for medical devices.