CDSCO License for Colon Computed Tomography System, Computer Aided Detection

Introduction to Colon Computed Tomography System, Computer Aided Detection

The Colon Computed Tomography System with Computer Aided Detection (CAD) represents an advanced software solution designed to assist radiologists in interpreting multi-slice computed tomography (MSCT) exams of the colon. Its primary function is to highlight potential polyps, thereby improving diagnostic accuracy and efficiency. Given its critical role in clinical diagnostics, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory to ensure safety, efficacy, and market access in India.

CDSCO Regulatory Framework for Software Medical Devices

Software devices like the Colon CT System fall under CDSCO’s purview as medical devices, specifically categorized under software that supports diagnostic decisions. Since the notification 29/Misc./03/2020-DC (198) dated 13.9.2021 covers this device, manufacturers and importers must adhere to the regulatory pathways prescribed for such software devices.

Risk Classification and License Requirements for Colon CT System

This device is classified as a Class B medical device under CDSCO regulations. Class B devices are considered low to moderate risk, and their manufacturing license is governed by the State Licensing Authority via the MD5 license process. The MD5 license process is specifically designed for Class A and B devices, which includes software devices intended for diagnostic support.

Manufacturing License Process (MD5) for Class B Software Devices

Obtaining an MD5 manufacturing license involves several important steps:

1. Test License Application (Form MD13): Before full license application, manufacturers must secure a test license to conduct necessary product testing.
2. Product Testing: The device must be tested at government-approved labs to validate conformance with applicable standards.
3. Document Preparation: Comprehensive documentation, including technical and quality management files, must be compiled.
4. License Application (Form MD3): Submission of the MD5 license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit by a notified body listed on the CDSCO portal is mandatory to verify compliance.
6. Responding to Queries: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of MD5 License: Upon successful review and audit, the MD5 license is granted.

Manufacturing License Documents Required for Colon CT System

For a Class B software device like the Colon CT System, the following documents are essential:

• Company Constitution Documents (Incorporation certificates, registration)
• Proof of Premises Ownership/Lease
• Technical Staff Qualifications and Experience
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed technical specifications and design data (Device Master File Guide)
• Plant Master File (PMF): Description of manufacturing facilities and processes (Plant Master File Guide)
• Essential Principles Checklist outlining compliance with safety and performance
• Risk Management File: Documented risk analysis and mitigation strategies (Risk Management)
• Test Reports from government-approved laboratories (Testing Laboratories)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents: ISO 13485 certification and associated procedures

Import License Process (MD15) for Colon CT System

If importing the Colon CT System software into India, an MD15 import license from the Central Licensing Authority is mandatory. The import license process includes:

• Preparation of required import documentation
• Submission of application on Form MD14 via the CDSCO MD Online Portal
• Addressing any department queries
• Grant of import license on Form MD15

Unlike manufacturing, no test license is required, but comprehensive documentation such as Free Sale Certificate, ISO 13485, CE Certificate, and manufacturing license from the country of origin must be provided.

Import License Documents Required

Key documents for MD15 import license include:

• Manufacturing License of the device from the country of origin
• Free Sale Certificate confirming market approval elsewhere
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution Documents

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3-4 months total.

  • Test license (MD13) takes 1.5-2 months
  • Product testing and lab reports take 2-3 weeks
  • Audit and license issuance take 1-1.5 months

• MD15 Import License: Approximately 5-6 months.

Proactive document preparation and prompt response to queries can significantly reduce processing time.

Government Fees and Costs

For the Colon CT System, a Class B device, the fees are as follows:

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD15 Import License: Rs 2,000 per site + Rs 1,000 per product

Budgeting for notified body audit fees, product testing charges, and consultancy (if needed) is also essential.

Common Challenges and Solutions

Challenge 1: Delays due to incomplete documentation

• Solution: Use a detailed checklist and expert review to ensure all documents are complete and compliant before submission.

Challenge 2: Testing failures or insufficient test reports

• Solution: Select accredited laboratories listed by CDSCO and conduct pre-tests in-house if possible to ensure compliance.

Challenge 3: Audit non-compliance

• Solution: Prepare your QMS and manufacturing processes thoroughly, conduct internal audits, and choose a notified body from the CDSCO notified bodies list with relevant expertise.

Expert Consultation and Support

With over 25 years of experience assisting 500+ companies, we understand the nuances of CDSCO licensing for software medical devices like the Colon CT System. Our tailored regulatory support includes:

• Gap analysis of existing documents
• Assistance with Device and Plant Master Files
• Coordination with notified bodies and testing labs
• End-to-end application management on the CDSCO MD Online Portal

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class B status and understand specific requirements using the Medical Device Classification guide.
2. Prepare Test License Application: Initiate the test license (Form MD13) through the CDSCO portal.
3. Engage Accredited Testing Labs: Schedule product testing with government-approved facilities.
4. Compile Documentation: Gather all technical, quality, and regulatory documents—refer to our comprehensive guides for DMF and PMF.
5. Select a Notified Body: Choose an auditor from the official Notified Bodies List to conduct your audit.
6. Submit MD5 License Application: Apply through the CDSCO MD Online Portal, track status, and respond swiftly to any queries.

Navigating the CDSCO licensing pathway for your Colon Computed Tomography System doesn’t have to be complex. With expert guidance, you can streamline the process, reduce delays, and ensure your innovative software device reaches the Indian market efficiently and compliantly.