CDSCO License for Duodenal-jejunal bypass liner

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

Navigating the regulatory landscape in India for innovative medical devices such as the Duodenal-jejunal bypass liner requires meticulous attention to detail and thorough preparation. This device—a sterile, stent-like implant used in gastroenterology to treat type 2 diabetes mellitus and obesity by acting as an impermeable barrier in the duodenum and jejunum—falls under Class C risk classification. As a device with significant clinical implications, strict adherence to the Central Drugs Standard Control Organization (CDSCO) regulations is mandatory for market entry.

With over 25 years of expertise assisting 500+ companies in obtaining CDSCO licenses, we provide an in-depth overview of the licensing process, practical timelines, costs, document requirements, and insider tips specifically for the Duodenal-jejunal bypass liner.

CDSCO Regulatory Framework for the Duodenal-jejunal Bypass Liner

The CDSCO regulates medical devices under the Medical Device Rules (MDR), 2017, which align with international standards to ensure patient safety and efficacy. Your device is notified under the category of gastroenterology with Notification No. 29/Misc./03/2020-DC (182) dated 27.09.2021. For Class C devices like this bypass liner, the licensing authority is the Central Licensing Authority (CLA) of CDSCO, reflecting the higher risk profile and clinical complexity.

Risk Classification and License Requirements

The Duodenal-jejunal bypass liner is classified as a Class C device based on its invasive nature and critical role in metabolic disease management. This classification mandates obtaining an MD9 manufacturing license if you are manufacturing in India, or an MD15 import license if you are importing the device.

• Class C Devices: Require MD9 license (Application Form MD7) granted by the Central Licensing Authority.
• For manufacturing, prior test license (Form MD13) for obtaining product testing is compulsory.

For a detailed understanding of classification, refer to our comprehensive Medical Device Classification guide.

Manufacturing License Process (MD9) for Duodenal-jejunal Bypass Liner

If you plan to manufacture this device in India, the process unfolds as follows:

1. Test License Application (Form MD13): Submit an application to obtain the test license, which allows you to produce samples for testing.
2. Product Testing: Samples must be tested at CDSCO-approved laboratories. For your device, testing will focus on sterility, biocompatibility, and mechanical integrity. Refer to the list of Testing Laboratories for approved facilities.
3. Document Preparation: Compile all required documents including technical files, Device Master File, Plant Master File, and risk management documentation.
4. Submit MD9 Application (Form MD7): File your manufacturing license application via the CDSCO MD Online Portal.
5. Inspection and Audit: CDSCO inspectors will conduct a thorough audit of your manufacturing facility, quality systems, and documentation.
6. Query Resolution: Address any queries raised by CDSCO during the review.
7. Grant of License: Upon successful review and audit, the MD9 manufacturing license will be issued.

Manufacturing License Documents Required

For a Class C device like the Duodenal-jejunal bypass liner, ensure you have the following documentation ready:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical and Quality Personnel
• Fire and Pollution No Objection Certificates (NOCs)
• Detailed Device Master File (DMF) outlining design, materials, manufacturing process (Device Master File guide)
• Plant Master File (PMF) describing manufacturing facilities and equipment (Plant Master File guide)
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File detailing hazard analysis and mitigation strategies (Risk Management)
• Test Reports from Government-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485 certified

Import License Process (MD15) for Duodenal-jejunal Bypass Liner

If you are an importer, the process is centralized and slightly different:

1. Document Preparation: Gather all required documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 and CE Certificates, Device and Plant Master Files, and wholesale license.
2. Application Submission: File the import license application on Form MD14 via the CDSCO MD Online Portal.
3. Review and Queries: CDSCO reviews the application and raises any queries.
4. Grant of License: Upon satisfactory response, the MD15 import license is issued.

Import License Documents Required

• Valid foreign manufacturer’s Manufacturing License
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for Indian importer
• Company Constitution and Incorporation Certificates

Timeline and Processing Duration

• MD9 Manufacturing License: Approximate total duration is 4-5 months.

  • Test License (MD13): 1.5-2 months
  • Testing and report generation: 1-1.5 months
  • Application submission and audit: 1-1.5 months
  • Query resolution and license grant: 15-30 days

• MD15 Import License: Typically takes 5-6 months due to thorough review of foreign documentation and compliance.

Government Fees and Costs

• MD9 License:

  • Application Fee: Rs. 50,000
  • Per product fee: Rs. 1,000

• MD15 Import License:

  • Class C devices attract Rs. 3,000 per site and Rs. 1,500 per product.

Keep in mind that testing fees, audit fees (if using a notified body), and consultancy costs are additional.

Common Challenges and Solutions

• Delayed Testing Reports: Selecting government-approved testing labs with proven turnaround times mitigates this risk. Check the Testing Laboratories list early.

• Incomplete Documentation: Use our comprehensive checklists and templates to ensure all Device Master File, Plant Master File, and risk management documentation are complete and aligned with CDSCO standards.

• Audit Non-compliance: Engage with CDSCO-recognized notified bodies early in the process to pre-audit your facility and quality management systems. Find notified bodies here.

• Query Resolution Delays: Prepare prompt, evidence-backed responses and maintain close communication with CDSCO officials.

Expert Consultation and Support

With our 25+ years of experience and a track record of over 500 successful CDSCO licensing projects, we guide manufacturers and importers through every step—from documentation to audit readiness and query management. Our tailored support ensures efficient compliance, reducing approval timelines and avoiding costly rejections.

Getting Started with Your CDSCO License Application for the Duodenal-jejunal Bypass Liner

1. Conduct a gap analysis of your current documentation against CDSCO requirements.
2. Engage a notified body early for audit preparation.
3. Select a government-approved testing laboratory and initiate sample testing.
4. Prepare your Device and Plant Master Files meticulously.
5. Register and submit your application on the CDSCO MD Online Portal.
6. Plan for post-submission follow-up to promptly address queries or deficiencies.

Embarking on this journey with a clear roadmap and expert support significantly enhances your chances of timely approval and successful market entry in India’s rapidly evolving medical device sector.

For personalized assistance tailored to your Duodenal-jejunal bypass liner or similar Class C devices, contact us to leverage our proven expertise and streamline your CDSCO licensing process.