CDSCO License for Externally-propelled flexible video colonoscope

Introduction to Externally-Propelled Flexible Video Colonoscopes and Regulatory Importance

The externally-propelled flexible video colonoscope is a critical medical device designed for the detailed visual examination of the adult colon. Primarily used for colorectal cancer screening and detecting other lower gastrointestinal (GI) diseases, this non-sterile, single-use endoscope features a highly flexible sleeve and distal tip, enhancing patient comfort and diagnostic accuracy. Given its pivotal role in oncology diagnostics and the sensitive nature of its intended use, regulatory compliance with the Central Drugs Standard Control Organisation (CDSCO) in India is mandatory before market entry.

Navigating the CDSCO licensing pathway ensures that manufacturers and importers meet stringent safety, quality, and performance standards, thereby protecting patient health and building trust with healthcare providers. With over 25 years of experience and having supported 500+ companies, we provide expert insights tailored specifically for Class B oncology devices like the flexible video colonoscope.

CDSCO Regulatory Framework for Flexible Video Colonoscopes

The CDSCO classifies medical devices into four risk classes (A, B, C, D) based on their potential risk to patients. The externally-propelled flexible video colonoscope falls under Class B, which includes low to moderate risk devices. Regulatory oversight for Class B devices is managed by State Licensing Authorities, requiring the manufacturer to obtain the MD5 license under Form MD3.

For importers, the process involves obtaining an import license (MD15) from the Central Licensing Authority. Both licenses ensure compliance with Indian Medical Device Rules 2017 and the relevant CDSCO notifications, including Notification File No. 29/Misc./03/2020-DC (153) dated 11.10.2022.

Risk Classification and License Requirements for Class B Devices

• Risk Class: B (Low-Moderate Risk)
• License Type for Manufacturing: MD5 License (Form MD3)
• License Authority: State Licensing Authority
• License Type for Importing: MD15 License (Form MD14)
• License Authority: Central Licensing Authority

The MD5 license process incorporates a mandatory test license (MD13) phase, product testing at CDSCO-approved labs, and an audit by a notified body to verify compliance with quality and safety standards.

Manufacturing License Process (MD5) for Flexible Video Colonoscopes

Obtaining an MD5 manufacturing license requires a well-structured approach:

1. Apply for Test License (MD13): Initial step to legally manufacture and test the device for 1.5 to 2 months.
2. Product Testing: Conduct product testing at CDSCO-approved testing laboratories to validate safety and performance. Refer to the official list of testing laboratories.
3. Document Preparation: Assemble required documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and QMS documents.
4. Submit Application via CDSCO MD Online Portal: Apply for MD5 using Form MD3.
5. Audit by Notified Body: Coordinate with a notified body for a comprehensive audit. Find suitable bodies in the Notified Bodies List.
6. Address Queries: Respond promptly to any queries raised by CDSCO or the notified body.
7. License Grant: Upon successful completion, the MD5 license is granted on Form MD5.

The entire process typically takes 3 to 4 months.

Manufacturing License Documents Required

For a Class B device like the flexible video colonoscope, essential documents include:

• Company Constitution and Registration Proof
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff (Qualifications and Experience)
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing device design, specifications, and manufacturing processes (DMF Guide)
• Plant Master File (PMF) describing the manufacturing facility (PMF Guide)
• Essential Principles Checklist demonstrating compliance with Indian regulations
• Risk Management File outlining risk assessments and mitigation strategies (Risk Management Guide)
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 compliant

Import License Process (MD15) for Flexible Video Colonoscopes

Importers of the flexible video colonoscope must secure the MD15 import license from the Central Licensing Authority. The steps include:

1. Document Preparation: Compile manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate or equivalent, DMF, PMF, wholesale license, and company constitution.
2. Application Submission: Submit the application via the CDSCO MD Online Portal using Form MD14.
3. Queries Resolution: Address any clarifications sought by CDSCO officials.
4. License Approval: The MD15 license is granted on Form MD15.

The import license process generally takes 5 to 6 months.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate issued by the regulatory authority of the exporting country
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and Registration Documents

Timeline and Processing Duration Summary

Planning ahead and starting the test license early can significantly streamline the overall timeline.

Government Fees and Costs

For Class B devices such as the externally-propelled flexible video colonoscope, fees are as follows:

• MD5 Manufacturing License:
  • Application Fee: Rs 5,000
  • Per Product Fee: Rs 500
• MD15 Import License:
  • Site Fee: USD 2,000 per site
  • Product Fee: USD 1,000 per product

Additional costs include testing fees at CDSCO-approved laboratories and notified body audit charges, which vary based on the notified body selected.

Common Challenges and Solutions

• Delayed Test Reports: Lab backlogs can slow down product testing. We recommend early coordination with CDSCO-approved labs to schedule tests in advance.
• Incomplete Documentation: Missing or inconsistent documents often lead to application rejection or queries. Our checklist-driven approach ensures completeness.
• Audit Non-Compliance: Preparing for notified body audits with mock audits and gap analyses can mitigate the risk of non-compliance findings.
• Query Resolution Delays: Prompt, clear, and comprehensive responses to CDSCO queries reduce processing time.

Expert Consultation and Support

With extensive experience supporting over 500 medical device companies, we offer end-to-end assistance—from document preparation, audit readiness, to timely application submissions on the CDSCO MD Online Portal. Our experts ensure your flexible video colonoscope meets all regulatory requirements, enabling a smooth market entry.

Getting Started with Your CDSCO License Application

To begin your CDSCO license journey for the externally-propelled flexible video colonoscope:

1. Assess Your Device Classification: Confirm Class B status and applicable licenses.
2. Prepare Technical Documentation: Develop comprehensive Device and Plant Master Files.
3. Initiate Test License Application (MD13): Submit early to align with manufacturing timelines.
4. Contact CDSCO-Approved Testing Labs: Schedule product testing promptly.
5. Select a Notified Body for Audit: Engage early for availability and audit scheduling.
6. Submit Application via CDSCO MD Online Portal: Ensure all documents are uploaded correctly.
7. Plan for Query Resolution: Assign dedicated resources for timely responses.

Our team is ready to guide you step-by-step, ensuring cost-effective and timely compliance. Reach out today to leverage our expertise and secure your CDSCO license with confidence.