CDSCO License for Transilluminator for breast evaluation

Comprehensive Guide to CDSCO Licensing for Transilluminator (Class D Medical Device)

As a specialized medical device used in interventional radiology, the Transilluminator for breast evaluation is an advanced diagnostic tool that utilizes near-infrared light to detect breast abnormalities such as cancer. Given its critical role in sensitive diagnostics and its classification as a Class D medical device under Indian regulations, obtaining the correct CDSCO license is essential for manufacturers and importers aiming to enter the Indian market.

With over 25 years of experience and having successfully guided more than 500 companies through CDSCO licensing processes, we provide you with a detailed, actionable roadmap tailored specifically for the Transilluminator.

CDSCO Regulatory Framework for Transilluminator (Class D Device)

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. The Transilluminator falls under Class D — the highest risk category — due to its diagnostic use in cancer detection and interventional radiology applications.

Class D devices require stringent compliance, including central licensing authority approval, extensive documentation, testing, and audits. The regulatory process is governed under the Medical Device Rules, 2017, and relevant notifications such as 29/Misc./03/2020-DC (146) dated 26.07.2021.

Risk Classification and License Requirements for Transilluminator

• Device Risk Class: D (High Risk)
• Applicable License: MD9 Manufacturing License (for manufacturers) or MD15 Import License (for importers)
• Authority: Central Licensing Authority (CDSCO HQ)

Due to the Class D classification, the license is issued centrally, involving rigorous evaluation including product testing and on-site audits.

Manufacturing License Process (MD9) for Transilluminator

Manufacturers of Transilluminator devices must obtain an MD9 manufacturing license issued by the CDSCO Central Licensing Authority.

Key Steps:

1. Apply for Test License (Form MD13): Before full manufacturing license, a test license is mandatory to conduct product testing.
2. Product Testing: Samples are tested at government-approved laboratories to confirm compliance with safety and performance standards.
3. Document Preparation: Compile comprehensive technical documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, Quality Management System documents, and clinical evidence.
4. License Application (Form MD7): Submit application for MD9 license through the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: Physical inspection of manufacturing facility, quality controls, and compliance with regulatory standards.
6. Query Resolution: Address any queries raised by CDSCO or auditors promptly.
7. License Grant (Form MD9): Upon successful audit and review, the manufacturing license is issued.

For a detailed overview, refer to our comprehensive MD9 License Guide.

Manufacturing License Documents Required for Transilluminator

Detailed documentation is critical for a successful application. Essential documents include:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Site
• Qualification and Experience Certificates of Technical Personnel
• Fire Safety NOC and Pollution Control NOC
• Device Master File (DMF): Detailed design, manufacturing, and performance data. See our Device Master File Guide.
• Plant Master File (PMF): Manufacturing facility details and quality control measures. Learn more in our Plant Master File Guide.
• Essential Principles Compliance Checklist
• Medical Device Risk Management File compliant with ISO 14971 (Risk Management Insights)
• Product Test Reports from CDSCO-approved labs (Testing Laboratories List)
• Product Labels, Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process (MD15) for Transilluminator

Importers of Transilluminators must obtain an MD15 import license from the CDSCO Central Licensing Authority.

Process Overview:

1. Document Preparation: Gather necessary documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate if applicable, and technical files.
2. Submission of Application (Form MD14): Apply online for the import license at the CDSCO MD Online Portal.
3. Queries and Clarifications: Respond promptly to any clarifications sought by CDSCO.
4. License Issuance (Form MD15): Once all requirements are fulfilled, the import license is granted.

For further information, refer to our Import License Guide.

Import License Documents Required for Transilluminator

Key documents include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate from the exporting country
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Address Proof
• Product Labeling and IFU

Timeline and Processing Duration

Given the high-risk classification of the Transilluminator, thorough preparation and timely responses to CDSCO queries are crucial to avoid delays.

Government Fees and Costs

Additional costs include product testing fees at government-approved labs and audit-related expenses.

Common Challenges and Practical Solutions

• Challenge: Delays due to incomplete documentation.

  • Solution: Prepare a detailed checklist and cross-verify documents before submission.

• Challenge: Difficulty in product testing due to complex device specifications.

  • Solution: Engage with CDSCO-approved testing laboratories early and provide complete technical details.

• Challenge: Audit non-compliance.

  • Solution: Conduct internal mock audits and ensure QMS compliance ahead of CDSCO inspections.

• Challenge: Query resolution delays.

  • Solution: Assign a dedicated regulatory liaison to respond swiftly to CDSCO queries.

Expert Consultation and Support

Navigating the CDSCO licensing process for Class D devices like the Transilluminator can be complex. Our expert regulatory consultants bring decades of hands-on experience to streamline your application, ensure compliance, and facilitate faster approvals.

We assist with:

• End-to-end documentation preparation
• Coordination with CDSCO and notified bodies
• Facilitating product testing and audits
• Training your team on regulatory best practices

Getting Started with Your CDSCO License Application for Transilluminator

1. Classify Your Device Accurately: Confirm the risk class and category using the official Medical Device Classification guide.
2. Gather Documentation: Begin compiling your DMF, PMF, Risk Management, and QMS documents.
3. Select Testing Laboratory: Choose an approved testing laboratory from the CDSCO Testing Laboratories List.
4. Initiate Test License Application: Apply for the MD13 test license via the CDSCO MD Online Portal.
5. Plan for Audit: Identify and prepare for the CDSCO audit as per MD9 guidelines.
6. Seek Expert Help: Engage with experienced regulatory consultants to avoid common pitfalls and expedite approval.

By following these targeted steps and leveraging seasoned expertise, manufacturers and importers can confidently navigate the regulatory landscape and bring the Transilluminator to the Indian healthcare market efficiently and compliantly.