CDSCO License for Breast transilluminator

Comprehensive CDSCO Licensing Guide for Breast Transilluminator (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having successfully guided 500+ companies through the complexities of CDSCO licensing, we understand the unique challenges faced by manufacturers and importers of specialized medical devices like the Breast Transilluminator. This device, classified as Class A under the CDSCO framework, is an essential oncology diagnostic tool designed to detect breast cancer and other abnormalities by using low-intensity visible and near-infrared light transmission.

Navigating the regulatory pathways for such a device requires meticulous planning, thorough documentation, and adherence to specific timelines and quality standards. Below, we provide a detailed, practical roadmap to obtaining your CDSCO manufacturing or import license, ensuring your Breast Transilluminator reaches the Indian market legally and efficiently.

CDSCO Regulatory Framework for Breast Transilluminator

The Breast Transilluminator falls under the Class A category as per the CDSCO medical device classification system. This classification denotes the lowest risk devices but still mandates compliance with essential principles and safety standards. The regulatory oversight for Class A devices is managed by the State Licensing Authority, requiring an MD5 manufacturing license for domestic manufacturers.

The device’s oncology application and electrical operation underscore the need for comprehensive risk management and quality assurance throughout its lifecycle. Compliance with the notified device standards under File No. 29/Misc./03/2020-DC (153) — Part 1, notified on 11.10.2022, is mandatory.

For an in-depth understanding of device classification and risk, visit our Medical Device Classification guide.

Risk Classification and License Requirements for Breast Transilluminator

• Device Risk Class: Class A (Low Risk)
• Applicable License: MD5 Manufacturing License (Form MD3)
• Authority: State Licensing Authority
• Processing Time: Approximately 3 to 4 months (including test license and audits)

Class A devices require a test license (Form MD13) before the manufacturing license application. This ensures the device complies with safety and performance standards via government-approved testing laboratories.

Manufacturing License Process (MD5) for Breast Transilluminator

The MD5 license procurement involves a multi-step process:

1. Apply for Test License (Form MD13): This initial step takes about 1.5 to 2 months and authorizes the manufacturer to produce samples for testing.
2. Product Testing: Samples must be tested in government-approved laboratories to verify compliance with the Essential Principles for Safety and Performance. Refer to the list of testing laboratories for approved centers.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and others (detailed below).
4. Submit Application for Manufacturing License (Form MD3): Apply online through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit is conducted by a notified body from the official notified bodies list to verify compliance.
6. Respond to Queries: Address any observations or queries raised by the licensing authority or notified body promptly.
7. Grant of MD5 License (Form MD5): Upon successful completion of audits and query resolution, the State Licensing Authority grants the manufacturing license.

Manufacturing License Documents Required for Breast Transilluminator

Successful license application hinges on thorough documentation. Manufacturers should prepare the following:

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Credentials of Technical Staff (Qualifications and Experience)
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed specifications, design drawings, and manufacturing processes. Our Device Master File guide provides a stepwise approach.
• Plant Master File (PMF): Manufacturing environment, equipment details, and quality control processes. Learn more from our Plant Master File guide.
• Essential Principles Checklist confirming compliance
• Risk Management File, demonstrating systematic hazard analysis and mitigation strategies; see our Risk Management resource.
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Breast Transilluminator

If you are an importer of the Breast Transilluminator, the MD15 import license is mandatory. This process is governed centrally by CDSCO and typically takes 5 to 6 months.

• Application Form: MD14
• Documents Required: Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.
• Fees: Fees vary by class; for Class A devices, the site fee is approximately $1000 and product fee is$50 per product.
• Application Submission: Through the CDSCO MD Online Portal.

For detailed import licensing guidance, check our Import License Guide.

Timeline and Processing Duration

Total Estimated Time: Approximately 3 to 4 months

Government Fees and Costs

• Test License Fee: Included in overall fees
• MD5 Manufacturing License Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs to consider:

• Testing laboratory fees (varies based on tests required)
• Notified body audit charges
• Consultant or regulatory service fees if you engage expert support

Common Challenges and Solutions

Challenge: Delays in product testing due to sample preparation or laboratory backlogs.

Solution: Engage early with approved testing labs and submit well-prepared, compliant samples to avoid retesting.

Challenge: Incomplete or inconsistent documentation causing audit observations.

Solution: Utilize comprehensive checklists and templates for Device Master File, Plant Master File, and Risk Management to ensure completeness.

Challenge: Misunderstanding of regulatory requirements leading to application rejections.

Solution: Work with experienced consultants who understand CDSCO’s expectations and can pre-emptively address potential gaps.

Challenge: Managing timelines effectively when coordinating among multiple stakeholders (labs, auditors, authorities).

Solution: Develop a project timeline with buffer periods and maintain active communication channels.

Expert Consultation and Support

Our company offers tailored consulting services dedicated to medical device licensing in India. With over 500 successful CDSCO licenses facilitated, we bring practical insights and hands-on assistance including:

• Gap analysis of your current compliance status
• Preparation and review of technical documentation
• Coordination with testing labs and notified bodies
• Application filing and follow-up management
• Training on post-market regulatory requirements

Partnering with seasoned experts reduces risks, accelerates approvals, and ensures regulatory compliance for your Breast Transilluminator.

Getting Started with Your CDSCO License Application

To initiate your licensing journey for the Breast Transilluminator, follow these actionable steps:

1. Confirm Device Classification: Verify Class A status and applicable guidelines.
2. Prepare Technical Documentation: Assemble your Device Master File and Plant Master File referencing our detailed guides.
3. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal to obtain authorization for sample manufacturing.
4. Coordinate Product Testing: Engage with government-approved testing labs early to schedule and execute necessary tests.
5. Compile Complete Application: Incorporate test reports, audit readiness documents, and all regulatory forms.
6. Schedule Notified Body Audit: Select notified bodies from the official list and prepare for inspection.
7. Submit Manufacturing License Application (Form MD3): Ensure online submission with all required attachments.
8. Address Queries Promptly: Respond to any audit or authority observations without delay.

By following this structured roadmap, you can confidently navigate the CDSCO licensing process for your Breast Transilluminator, ensuring compliance and timely market entry.

Should you require personalized assistance, please connect with our expert team to leverage our extensive experience in Indian medical device regulations and accelerate your product approval.