CDSCO License for Flexible video colonoscope, single-use

Introduction to Flexible Video Colonoscope (Single-Use) and Regulatory Importance

Flexible video colonoscopes, especially single-use sterile endoscopes designed for comprehensive visual examination and treatment of the lower gastrointestinal tract, represent an essential medical device in gastroenterology. Given their critical role in patient diagnostics and interventions, these devices fall under Class B risk classification per CDSCO regulations. Ensuring timely and compliant regulatory approval through the Central Drugs Standard Control Organization (CDSCO) is paramount for manufacturers and importers aiming to access the Indian market.

With over 25 years of experience assisting 500+ companies in navigating CDSCO licensing, we understand that streamlined regulatory compliance is crucial to market success. This guide provides an in-depth roadmap tailored specifically for flexible video colonoscopes (single-use), covering all steps from risk classification to license issuance.

CDSCO Regulatory Framework for Flexible Video Colonoscope

Flexible video colonoscopes are regulated under the medical device category of gastroenterology, notified under 29/Misc./03/2020-DC (182) dated 27.09.2021. The CDSCO classifies this device as Class B due to moderate risk associated with its invasive use and potential impact on patient safety.

The regulatory framework requires manufacturers to obtain a manufacturing license (MD5) issued by the State Licensing Authority. All applications and communications must be submitted via the CDSCO MD Online Portal. This portal serves as the official gateway for document submission, fee payment, and status tracking.

Risk Classification and License Requirements for Class B Devices

Class B devices like the flexible video colonoscope require an MD5 license under Form MD3, which is issued by the State Licensing Authority. This classification mandates compliance with essential principles of safety and performance, including sterility, biocompatibility, and functional integrity.

Before applying for the manufacturing license, manufacturers must obtain a test license (MD13) to conduct product testing in government-approved laboratories. The entire licensing process typically spans 3 to 4 months, including testing, audit, and clearance.

For comprehensive details on device classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Flexible Video Colonoscope

1. Apply for Test License (Form MD13): Submit application for a test license allowing product testing in approved labs; processing time is approximately 1.5 to 2 months.
2. Laboratory Testing: Conduct mandatory tests such as sterility, electrical safety, image quality, and biocompatibility through CDSCO-approved testing laboratories.
3. Document Preparation: Compile all required documents including Device Master File and Plant Master File.
4. Submit Manufacturing License Application (Form MD3): Apply for the MD5 manufacturing license via the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo a thorough audit by a notified body (refer to the Notified Bodies List).
6. Query Resolution: Respond promptly to any queries from the licensing authority or notified body.
7. License Grant: Upon successful audit and document verification, the MD5 license is granted.

This stepwise process ensures compliance with quality management systems and regulatory standards specific to Class B devices.

Manufacturing License Documents Required for MD5

Accurate and complete documentation is critical. The following are mandatory:

• Company Constitution/Registration Certificate
• Proof of Ownership or Rent Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire NOC and Pollution Control NOC
• Detailed Device Master File (DMF). For guidance, see our Device Master File guide
• Comprehensive Plant Master File (PMF). Learn more at our Plant Master File guide
• Essential Principles Checklist affirming compliance with safety and performance requirements
• Risk Management File detailing identified hazards and mitigation strategies. Refer to our Risk Management resource
• Valid Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification preferred)

Preparing these documents meticulously can significantly reduce processing delays.

Import License Process (MD15) for Flexible Video Colonoscope

For importers intending to bring single-use flexible video colonoscopes into India, the MD15 import license is mandatory. The process involves:

• Document preparation, including the manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, and CE Certificate
• Application submission on the CDSCO MD Online Portal using Form MD14
• Resolution of any departmental queries
• Final grant of the MD15 license

Note that a test license is not required for import licensing. The average timeline is 5 to 6 months.

For detailed import license guidance, visit our Import License guide.

Import License Documents Required for MD15

• Valid Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution

Ensuring all documents are current and authentic expedites application processing.

Timeline and Processing Duration

Manufacturers should plan timelines accordingly, factoring in potential delays in audit scheduling and query resolution.

Government Fees and Costs

• MD5 License (Class B Device):

  • Application Fee: Rs 5,000
  • Per Product Fee: Rs 500

• Test License (MD13): Included in the overall process, no separate fees beyond standard application charges

• Import License (MD15):

  • Site Fee: $2,000
  • Per Product Fee: $1,000

Additional costs may include testing fees charged by approved laboratories and audit fees payable to notified bodies.

Common Challenges and Solutions

• Delayed Testing Results: Engage with CDSCO-approved labs early. Maintain regular communication to track testing progress.

• Incomplete Documentation: Utilize our comprehensive checklists (DMF, PMF, Risk Management) to avoid omissions.

• Audit Non-Compliance: Conduct pre-audit internal assessments to ensure readiness.

• Query Resolution Delays: Assign dedicated personnel to respond promptly and accurately to CDSCO queries.

• Incorrect Fee Submission: Double-check fee amounts and payment receipts to prevent application rejection.

Our extensive experience has enabled us to develop tailored mitigation strategies that accelerate approvals.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our team of seasoned consultants offers end-to-end support, including:

• Gap analysis of your current compliance status
• Preparation and review of Device and Plant Master Files
• Assistance in test license applications and coordination with testing labs
• Audit readiness and liaison with notified bodies
• Handling query responses and document resubmissions

Partnering with experts ensures your flexible video colonoscope obtains timely market entry without regulatory hurdles.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal: Create your applicant profile at CDSCO MD Online Portal.

2. Initiate Test License Application (MD13): Begin with securing the test license to enable product testing.

3. Engage Approved Testing Laboratories: Schedule testing early to fit within your project timeline.

4. Prepare Comprehensive Documentation: Leverage our Device Master File and Plant Master File templates.

5. Schedule Notified Body Audit: Choose an appropriate notified body from the Notified Bodies List to conduct your audit.

6. Submit Manufacturing License Application (MD3): Upload all documents and pay fees through the online portal.

7. Monitor Application Status and Respond to Queries: Stay proactive to ensure a smooth approval process.

If you are an importer, start by compiling your import documentation and apply for the MD15 license after your manufacturing license is in place.

By following these actionable steps and leveraging our decades of regulatory consulting expertise, your flexible video colonoscope can successfully meet CDSCO requirements and reach Indian healthcare providers efficiently.