CDSCO License for Gastrointestinal endoscopic clip, short-term

Comprehensive Guide to CDSCO Licensing for Gastrointestinal Endoscopic Clips (Short-Term, Class B)

Introduction: Understanding Your Gastrointestinal Endoscopic Clip and Regulatory Importance

Gastrointestinal endoscopic clips, short-term use, are specialized sterile medical devices designed for temporary placement (≤30 days) within the GI tract during endoscopic procedures. Their primary applications include endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and treatment of mucosal or submucosal defects. Given their critical role in patient safety and procedural success, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) in India ensures these devices meet stringent safety, quality, and efficacy standards.

At our consultancy, with over 25 years of experience and having assisted 500+ manufacturers and importers, we understand the nuances and challenges of obtaining CDSCO licenses for such Class B devices. This guide provides practical, actionable insights tailored specifically to gastrointestinal endoscopic clips, enabling you to navigate the regulatory framework confidently.

CDSCO Regulatory Framework for Gastrointestinal Endoscopic Clips

Classified under risk Class B, gastrointestinal endoscopic clips fall under moderate risk medical devices according to CDSCO’s Medical Device Rules (MDR), 2017. The relevant notification for this device is 29/Misc./03/2020-DC (182), dated 27.09.2021, which outlines regulatory requirements specific to gastroenterology devices.

Manufacturing of such devices in India requires a MD5 manufacturing license, granted by the State Licensing Authority, while importers must secure an MD15 import license issued by the Central Licensing Authority.

Risk Classification and License Requirements

• Risk Class: B (Moderate risk)
• License Type for Manufacturing: MD5 License (Application Form MD3)
• License Type for Import: MD15 License (Application Form MD14)

Class B devices must comply with enhanced regulatory controls, including testing in government-approved laboratories, quality management systems, and audit by notified bodies.

Manufacturing License Process (MD5 License for Class B Devices)

The MD5 license process involves several critical steps, typically spanning 3 to 4 months:

1. Test License (Form MD13): First, obtain a test license valid for 6 months, which allows product testing in CDSCO-recognized labs. This step takes approximately 1.5 to 2 months.

2. Product Testing: Submit samples of your gastrointestinal endoscopic clips to government-approved laboratories for comprehensive testing covering biocompatibility, sterility, mechanical strength, and other applicable parameters. You can check the list of testing laboratories for suitable facilities.

3. Document Preparation: Prepare and compile all required technical and quality documents, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and quality management system documentation.

4. Application Submission: Apply online via the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body: A notified body will conduct a thorough audit of your manufacturing facility and quality systems. The list of notified bodies can help you select an accredited auditor.

6. Resolution of Queries: Address any observations or queries raised by CDSCO or the notified body promptly.

7. Grant of License: Upon satisfactory review, the MD5 license will be issued.

For a detailed procedural breakdown, refer to our comprehensive MD5 License Guide.

Manufacturing License Documents Required for Gastrointestinal Endoscopic Clips

To streamline your application, ensure the following documents are prepared meticulously:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualifications and Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, manufacturing processes, and validation
• Plant Master File (PMF) covering manufacturing environment, equipment, and procedures
• Essential Principles Checklist demonstrating compliance with safety and performance standards
• Risk Management File outlining hazard identification and mitigation strategies
• Product Test Reports from CDSCO-recognized laboratories
• Labels and Instructions for Use (IFU) complying with CDSCO labeling guidelines
• Quality Management System Documents (ISO 13485:2016 certification is highly recommended)

Our Device Master File guide and Plant Master File guide provide in-depth assistance on document creation.

Import License Process (MD15 License for Class B Devices)

For importers, the MD15 license process involves:

1. Document Compilation: Collect key documents such as a valid manufacturing license from the country of origin, Free Sale Certificate, CE Certificate (if applicable), ISO 13485:2016 certification, Device Master File, Plant Master File, wholesale license, and company constitution.

2. Application Submission: Submit Form MD14 via the CDSCO MD Online Portal.

3. Review and Queries: CDSCO evaluates the application and may raise queries which need to be addressed within stipulated timelines.

4. Grant of License: Upon successful review, the import license (MD15) is issued, typically within 5 to 6 months.

For more details, refer to our Import License Guide.

Import License Documents Required

• Valid and current Manufacturing License from the exporting country
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate or equivalent compliance certificates
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

Government Fees and Costs

• MD5 License Manufacturing Fees: Rs 5,000 per application + Rs 500 per product
• Test License (MD13) Fees: Included in the overall process
• MD15 Import License Fees:
  • Class A & B devices: $1,000 per site +$50 per product

Note that additional costs include notified body audit fees, product testing fees at government-approved labs, and consultancy charges, if applicable.

Common Challenges and Solutions

• Delayed Test Reports: Coordinate early with testing labs to avoid bottlenecks. Prioritize labs with proven turnaround times.
• Incomplete Documentation: Use checklists and templates from trusted sources. Our guides on Device Master Files and Plant Master Files are invaluable.
• Audit Non-Compliance: Engage experienced notified bodies and conduct internal audits prior to official inspections.
• Query Management Delays: Assign dedicated regulatory personnel to respond promptly to CDSCO queries.

Expert Consultation and Support

Our seasoned team offers end-to-end support, from product classification to final license grant. We customize strategies for gastrointestinal endoscopic clips based on your manufacturing scale, import plans, and compliance readiness. Leveraging our extensive network of notified bodies and testing laboratories ensures smooth audit and testing phases.

Getting Started with Your CDSCO License Application for Gastrointestinal Endoscopic Clips

1. Confirm Device Classification: Verify your device as Class B using the Medical Device Classification resource.

2. Prepare Technical Files: Begin compiling your Device Master File and Plant Master File with attention to the specific features of endoscopic clips.

3. Apply for Test License: Submit your MD13 application on the CDSCO MD Online Portal.

4. Coordinate Product Testing: Schedule product testing at CDSCO-approved labs early to streamline timelines.

5. Engage a Notified Body: Select an appropriate notified body from the list available here for your audit.

6. Submit MD5 Application: Once testing is complete and documents are ready, apply using Form MD3.

7. Prepare for Audit and Queries: Conduct internal reviews and be ready to address audit findings and regulatory queries swiftly.

By following these focused steps and leveraging expert support, manufacturers of gastrointestinal endoscopic clips can achieve regulatory compliance efficiently and enter the Indian market with confidence.

For personalized assistance and to kickstart your CDSCO application, contact our regulatory experts who have successfully guided over 500 companies through this journey.