CDSCO License for Breast ultrasound imaging system

Comprehensive Guide to CDSCO Licensing for Breast Ultrasound Imaging Systems (Class C)

Breast ultrasound imaging systems are sophisticated medical devices used extensively in oncology for intracorporeal ultrasound diagnostics and endosonography procedures involving breast tissue. These AC-powered assemblies, often integrated with specialized imaging tables, are crucial for obtaining reproducible, high-quality diagnostic images that aid in early detection and treatment planning of breast cancer.

Given their critical role and complexity, breast ultrasound imaging systems are classified as Class C under the Indian medical device regulatory framework. This classification mandates a rigorous licensing process overseen by the Central Drugs Standard Control Organization (CDSCO) to ensure safety, efficacy, and quality compliance before market entry.

With over 25 years of regulatory consulting experience and having supported 500+ companies in successful CDSCO licensing, we provide you with a detailed roadmap to navigate the licensing requirements specific to this device type and risk class.

CDSCO Regulatory Framework for Breast Ultrasound Imaging Systems

Breast ultrasound imaging systems fall under the oncology category and are notified under File No. 29/Misc./03/2020-DC (153) — Part 1, dated 11.10.2022. Being a Class C device, they are subject to centralized regulatory oversight by CDSCO’s Central Licensing Authority.

The key regulatory approvals required include:

• MD9 Manufacturing License (Form MD7) for domestic manufacturing
• MD15 Import License (Form MD14) for importing devices

Both licenses are essential for legal manufacture or import of breast ultrasound imaging systems in India.

To initiate your application, use the CDSCO MD Online Portal—the official gateway for all medical device licensing procedures.

Risk Classification and License Requirements for Breast Ultrasound Imaging Systems

The classification as Class C reflects the moderate to high risk associated with intracorporeal diagnostic devices used in oncology. This classification affects the licensing path:

*Note: Fees are approximate and subject to change.

Manufacturers must first secure a test license (Form MD13) to conduct product testing before submitting the manufacturing license application.

MD9 Manufacturing License Process for Breast Ultrasound Imaging Systems

Obtaining an MD9 license is a multi-step process involving product testing, documentation, and inspection.

Step 1: Obtain Test License (Form MD13)

• Timeline: 1.5 to 2 months
• Purpose: Legally manufacture samples for testing

Step 2: Product Testing

• Conduct tests at CDSCO-approved government laboratories. A list of Testing Laboratories is available.
• Testing ensures compliance with Indian standards and international safety norms.

Step 3: Prepare Documentation

• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist
• Risk Management File
• Test Reports
• Quality Management System (QMS) Documents (ISO 13485 compliant)
• Labels and Instructions for Use (IFU)

Our detailed Device Master File guide and Plant Master File guide can help streamline this step.

Step 4: Submit Application on CDSCO MD Online Portal

• Use Form MD7
• Upload all required documents

Step 5: Audit by CDSCO Inspectors

• Physical audit of manufacturing premises
• Review of QMS and compliance with notified standards

Step 6: Address Queries

• Respond promptly to any clarifications or additional information requests

Step 7: Grant of MD9 License

• License issued on Form MD9, valid typically for 5 years

For a detailed walkthrough, refer to our MD9 License Guide.

Manufacturing License Documents Required for Breast Ultrasound Imaging Systems

Ensure the following documents are prepared accurately:

• Company Constitution / Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist
• Risk Management File (per ISO 14971 guidelines)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Certificates (ISO 13485:2016)

Having a comprehensive and well-organized documentation package reduces review time and minimizes queries from CDSCO.

Import License Process (MD15) for Breast Ultrasound Imaging Systems

Importers must apply for the MD15 license to legally bring breast ultrasound imaging systems into India.

Step 1: Document Preparation

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Step 2: Application Submission

• File application via the CDSCO MD Online Portal using Form MD14

Step 3: Review and Queries

• CDSCO evaluates documents and may raise queries

Step 4: Grant of MD15 Import License

• Typically takes 5-6 months

Import fees for Class C devices are approximately $3,000 per site and$1,500 per product.

For comprehensive guidance, explore our Import License Guide.

Timeline and Processing Duration

Planning ahead and maintaining open communication with CDSCO can help avoid delays.

Government Fees and Costs

• MD9 Manufacturing License: ₹50,000 per application + ₹1,000 per product
• MD15 Import License: $3,000 per site +$1,500 per product for Class C devices

Additional costs include testing fees, notified body audit charges, and consultant fees if outsourcing regulatory assistance.

Budgeting accurately prevents last-minute financial surprises.

Common Challenges and Solutions in CDSCO Licensing

Challenge: Delays in Product Testing

Solution: Engage with CDSCO-approved testing labs early and submit test samples promptly. Refer to the official Testing Laboratories list to select accredited labs.

Challenge: Incomplete Documentation

Solution: Use checklists from regulatory experts and leverage our Plant Master File guide and Device Master File guide to ensure thoroughness.

Challenge: Audit Non-Compliance

Solution: Prepare your QMS in line with ISO 13485 and understand CDSCO audit criteria. Training for staff and mock audits can mitigate risks.

Challenge: Complex Query Resolution

Solution: Respond promptly with clear, evidence-backed explanations. Maintaining good communication with CDSCO officers is crucial.

Expert Consultation and Support

Navigating CDSCO licensing for Class C devices like breast ultrasound imaging systems requires specialized knowledge. Our expert regulatory consulting services have empowered over 500 manufacturers and importers to achieve timely approvals by:

• Preparing and reviewing complete documentation
• Coordinating with notified bodies and testing labs
• Managing audit preparations
• Facilitating communication with CDSCO authorities

Partnering with seasoned consultants ensures compliance and accelerates market access.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm Class C for your breast ultrasound imaging system using the Medical Device Classification tool.

2. Gather Required Documents: Begin compiling technical files, company credentials, and quality certificates.

3. Apply for Test License (MD13): Submit via the CDSCO MD Online Portal to start product testing.

4. Engage Accredited Testing Labs: Schedule product testing early to avoid bottlenecks.

5. Prepare Manufacturing License Application (MD7): Use our MD9 License Guide to ensure completeness.

6. Plan for Audits: Conduct internal readiness assessments ahead of CDSCO inspections.

7. Consider Expert Support: Reach out to experienced regulatory consultants to streamline the process.

Taking these actionable steps will position you for a smooth licensing journey and successful market entry of your breast ultrasound imaging system in India.

For personalized support, contact our regulatory experts with over two decades of CDSCO licensing experience.

By adhering to the structured process outlined above and leveraging expert insights, manufacturers and importers of breast ultrasound imaging systems can confidently meet CDSCO regulatory requirements and bring their critical oncology diagnostic devices to the Indian healthcare market.