CDSCO License for Mammographic  x-ray system

Comprehensive Guide to CDSCO Licensing for Mammographic X-Ray Systems (Class C)

Mammographic x-ray systems play a critical role in breast cancer screening and diagnosis by producing high-quality radiographs of the breast tissue. As interventional radiology devices classified as Class C under the CDSCO regulatory framework, they require thorough evaluation and licensing before entry into the Indian market. With over 25 years of experience assisting 500+ medical device companies, we provide you with a step-by-step, practical guide to obtaining your CDSCO licenses efficiently and compliantly.

Understanding the CDSCO Regulatory Framework for Mammographic X-Ray Systems

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, including mammographic x-ray systems, under the Medical Device Rules, 2017. These devices fall under Class C due to their medium to high risk, involving ionizing radiation and direct patient interaction.

Compliance ensures patient safety, device performance, and market authorization. According to the notification [29/Misc./03/2020-DC (146)] dated 26.07.2021, mammographic x-ray systems are subject to stringent regulatory scrutiny, including manufacturing and import licensing.

Risk Classification and License Requirements for Mammographic X-Ray Systems

• Risk Class: Class C (Medium to High Risk)
• Applicable Licenses:
  • Manufacturing License: MD9 (Form MD7) granted by Central Licensing Authority
  • Import License: MD15 (Form MD14) granted by Central Licensing Authority

These licenses assure that the device meets Indian regulatory standards for safety and efficacy.

Manufacturing License Process for Mammographic X-Ray Systems (MD9)

Stepwise Process:

1. Test License (Form MD13): Initially, manufacturers must obtain a test license to manufacture the device for testing purposes. This phase typically takes 1.5 to 2 months.
2. Laboratory Testing: Devices must undergo testing at CDSCO-approved laboratories to verify compliance with Indian standards and essential principles. Testing Laboratories List provides authorized labs.
3. Documentation Preparation: Prepare comprehensive technical documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission: Apply online via the CDSCO MD Online Portal using Form MD7.
5. Regulatory Audit: CDSCO inspectors conduct a facility audit and review the documentation.
6. Query Resolution: Address any queries or deficiencies raised during audit or review.
7. License Grant: Upon successful compliance, the MD9 manufacturing license is granted.

Timeline:

• Entire process takes approximately 4 to 5 months.

Manufacturing License Documents Required for MD9

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of premises ownership or lease agreement
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) — for detailed device design and manufacturing info (Device Master File Guide)
• Plant Master File (PMF) — details of manufacturing site (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File complying with ISO 14971 (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Device labels and Instructions for Use (IFU)
• Quality Management System documents (preferably ISO 13485:2016 certified)

Import License Process for Mammographic X-Ray Systems (MD15)

For importers, the MD15 license is mandatory to bring Class C devices into India.

Stepwise Process:

1. Document Preparation: Assemble all required documents including manufacturing license from the country of origin, Free Sale Certificate, and quality certifications.
2. Online Application: Submit application through the CDSCO MD Online Portal using Form MD14.
3. Review and Queries: CDSCO evaluates documents and may raise queries.
4. License Issuance: Upon satisfactory review, import license MD15 is granted.

Timeline:

• Expect approximately 5 to 6 months for processing.

Import License Documents Required (MD15)

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

Government Fees and Costs

Note: Fees are subject to revision; always confirm on CDSCO MD Online Portal.

Timeline and Processing Duration Summary

• MD9 Manufacturing License: 4–5 months including test license and audit
• MD15 Import License: 5–6 months
• Test license (MD13) issuance: 1.5–2 months before MD9

Common Challenges and Practical Solutions

Challenge 1: Delays in Laboratory Testing

• Solution: Engage with accredited testing labs early and confirm sample requirements to avoid backlogs.

Challenge 2: Incomplete or Non-Compliant Documentation

• Solution: Use expert-prepared templates for Device Master File and Risk Management Files. Review using the Device Master File Guide.

Challenge 3: Audit Non-Conformities

• Solution: Conduct internal pre-audit assessments and ensure all QMS processes align with ISO 13485 standards.

Challenge 4: Navigating Regulatory Queries

• Solution: Maintain timely communication with CDSCO authorities and provide thorough, documented responses.

Expert Consultation and Support

With extensive experience navigating CDSCO’s regulatory landscape for Class C devices like mammographic x-ray systems, we offer tailored support including:

• Comprehensive document preparation
• Test license application assistance
• Coordination with notified bodies and laboratories
• Pre-audit readiness assessments
• Query resolution and follow-up

Our proactive approach has helped over 500 companies launch their devices successfully in India.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device is Class C using the Medical Device Classification guide.
2. Initiate Test License Application (MD13): File through the CDSCO MD Online Portal to start manufacturing for testing.
3. Plan for Device Testing: Coordinate with CDSCO-approved labs early to schedule testing.
4. Prepare Key Documents: Use our guides to develop your Device Master File, Plant Master File, and Risk Management documentation.
5. Submit MD9 Application: Once testing is complete, submit Form MD7 via the online portal.
6. Prepare for Audit: Arrange your QMS and facility for inspection.
7. Monitor Application Progress: Respond promptly to any CDSCO queries.
8. Apply for Import License (MD15) if applicable: Assemble import documents and file Form MD14.

By following these practical steps and leveraging expert guidance, you can streamline your path to obtain the required CDSCO licenses for mammographic x-ray systems and successfully enter the Indian market.

For personalized support, reach out to our regulatory experts who have a proven track record in medical device compliance.

For more detailed insights, explore our dedicated guides on MD9 License, Import License, and Risk Management.