CDSCO License for Flexible video colonoscope, reusable

Comprehensive Guide to CDSCO Licensing for Flexible Video Colonoscope (Reusable) – Class B Medical Device

Flexible video colonoscopes are critical medical devices used for the visual examination and treatment of the lower gastrointestinal (GI) tract. As a reusable, flexible endoscope, this device falls under Class B in India’s medical device risk classification system, regulated by the Central Drugs Standard Control Organization (CDSCO). With over 25 years of experience and having assisted more than 500 companies, we provide you with a detailed, step-by-step roadmap to efficiently obtain your CDSCO license for manufacturing this device in India.

CDSCO Regulatory Framework for Flexible Video Colonoscopes

The CDSCO governs the import, manufacture, and sale of medical devices in India under the Medical Device Rules, 2017 (MDR 2017). Flexible video colonoscopes are categorized under gastroenterology devices and notified specifically under notification 29/Misc./03/2020-DC (182) as of 27.09.2021. Compliance with these rules ensures safety, quality, and performance standards are met before market access.

Risk Classification and License Requirements for Flexible Video Colonoscopes

According to CDSCO classification, flexible video colonoscopes are Class B devices (low to moderate risk). This classification determines the licensing pathway:

• Manufacturing License: MD5 License (Form MD3), issued by the State Licensing Authority
• Import License: MD15 License (Form MD14), issued by the Central Licensing Authority

Class B devices require thorough product testing and quality management, but the regulatory burden is comparatively moderate versus higher-risk devices.

Manufacturing License Process (MD5) for Flexible Video Colonoscopes

The MD5 license process for Class B devices involves multiple steps:

1. Test License (Form MD13): Apply for a test license to manufacture and test the device prototype. This phase typically takes 1.5 to 2 months.
2. Testing: Submit product samples to CDSCO-approved government testing laboratories. Refer to the Testing Laboratories list.
3. Document Preparation: Compile all technical and quality documents including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, and Risk Management File.
4. Application Submission: Apply for manufacturing license on Form MD3 via the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body for on-site audit of your manufacturing facility. Check the Notified Bodies list for approved agencies.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of License (Form MD5): Upon successful compliance, the State Licensing Authority issues the MD5 manufacturing license.

Manufacturing License Documents Required for Flexible Video Colonoscopes

Prepare the following documentation meticulously:

• Company Constitution (Incorporation Certificates)
• Proof of ownership/lease of manufacturing premises
• Qualification documents of technical staff (MD, engineers, QA personnel)
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and validation (See our Device Master File Guide)
• Plant Master File (PMF) describing manufacturing processes and quality systems (See our Plant Master File Guide)
• Essential Principles Checklist adherence
• Risk Management File that identifies and mitigates hazards (Risk Management Insights)
• Product Test Reports from government-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents (ISO 13485:2016 compliant)

Import License Process (MD15) for Flexible Video Colonoscopes

If you are an importer rather than a manufacturer, the MD15 import license process applies:

1. Document Preparation: Compile documents including manufacturing license, Free Sale Certificate from the country of origin, ISO 13485 certificate, CE certificate (if applicable), DMF, PMF, wholesale license, and company constitution.
2. Apply using Form MD14 on the CDSCO MD Online Portal.
3. Query Resolution: Address departmental queries.
4. License Grant: The Central Licensing Authority issues the import license (MD15) within 5-6 months.

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 and Plant Master File
• Wholesale license for distribution
• Company Constitution

Timeline and Processing Duration

For your flexible video colonoscope, anticipate around 3-4 months for the complete manufacturing license process including test license and audit.

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD15 Import License:
  • Class B devices: $2,000 per site +$1,000 per product (payable in INR)

Additional costs include fees for notified body audits, testing charges by government labs, and consultancy fees if you engage regulatory experts.

Common Challenges and Solutions

• Delayed Testing Results: Plan ahead and submit samples early to government testing labs, which often have backlogs.
• Incomplete Documentation: Use detailed checklists and consult experienced consultants to avoid missing critical documents like DMF or Risk Management files.
• Audit Readiness: Prepare your manufacturing site according to notified body requirements, focusing on QMS and cleanliness.
• Query Response: Maintain a dedicated team to handle CDSCO queries promptly to avoid delays.

Expert Consultation and Support

With over 25 years of regulatory experience, we have successfully guided 500+ companies through the CDSCO licensing maze. Our expertise includes document preparation, audit facilitation, and regulatory strategy tailored specifically for gastroenterology devices such as flexible video colonoscopes.

Getting Started with Your CDSCO License Application

1. Confirm Device Classification: Verify your device is Class B using the Medical Device Classification tool.
2. Prepare Test License Application: Start with Form MD13 via the CDSCO MD Online Portal.
3. Engage Testing Laboratories: Choose an approved testing lab early in the process.
4. Compile Technical Documentation: Utilize our guides for DMF and PMF to ensure regulatory compliance.
5. Schedule Notified Body Audit: Contact notified bodies from the official list here.
6. Submit Manufacturing License Application: Once testing and audit are complete, apply with Form MD3.

We recommend initiating the process at least 6 months before your planned market launch to accommodate all regulatory steps smoothly.

For personalized support or to outsource your CDSCO licensing, contact us today and leverage our deep expertise to expedite your flexible video colonoscope’s market entry in India.