CDSCO License for Breast 3-D infrared imaging/vascular analysis system

Comprehensive Guide to CDSCO Licensing for Breast 3-D Infrared Imaging/Vascular Analysis System

As a vital oncology medical device, the Breast 3-D infrared imaging/vascular analysis system plays a crucial role in breast cancer risk examinations by complementing mammography screening. This sophisticated assembly of AC-powered devices offers three-dimensional breast imaging and vascular analysis, making it an advanced diagnostic aid. Given its critical healthcare application and classification as a Class C device under the CDSCO framework, obtaining the correct regulatory approvals is essential for market access in India.

With over 25 years of experience and having supported more than 500 companies in securing CDSCO licenses, we offer you a detailed, practical roadmap to successfully navigate the regulatory process for your Breast 3-D infrared imaging system.

CDSCO Regulatory Framework for Breast 3-D Infrared Imaging/Vascular Analysis System

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017, updated periodically. Your device falls under the oncology category with Notification File No. 29/Misc./03/2020-DC (153) — Part 1, dated 11.10.2022.

Being a Class C medical device, it is classified as moderate to high risk, requiring stringent regulatory scrutiny by the Central Licensing Authority (CLA) for manufacturing and import licensing.

Learn more about Medical Device Classification to understand the risk criteria.

Risk Classification and License Requirements for Class C Devices

Class C devices require CDSCO’s central approval rather than state-level, reflecting their higher risk profile. The key license types involved are:

• MD9 Manufacturing License (Form MD7) for domestic manufacturers
• MD15 Import License (Form MD14) for importers

Both licenses demand rigorous documentation, product testing, and audits to ensure compliance with Indian safety, quality, and efficacy standards.

Manufacturing License Process (MD9) for Breast 3-D Infrared Imaging System

The MD9 license process typically spans 4 to 5 months and involves several critical steps:

1. Test License (Form MD13): Initiate with a test license application to conduct product testing. This step usually takes 1.5 to 2 months.

2. Product Testing: Have your device tested at government-approved laboratories listed by CDSCO. Testing covers electrical safety, performance, and clinical efficacy as applicable.

3. Document Preparation: Compile comprehensive technical documentation, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.

4. License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.

5. Inspection & Audit: CDSCO inspectors will audit your manufacturing site and QMS to verify compliance.

6. Query Resolution: Address any observations or queries raised during inspection promptly.

7. License Grant: Upon satisfactory review, CDSCO issues the MD9 license (Form MD9).

For an in-depth walkthrough, refer to our MD9 License Guide.

Manufacturing License Documents Required

For Class C devices like the Breast 3-D infrared imaging system, prepare the following documents meticulously:

• Company Constitution (Incorporation Certificates, Memorandum & Articles of Association)
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Qualification and Experience Documents
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed design, specifications, manufacturing process
• Plant Master File (PMF): Facility details, equipment, utilities
• Essential Principles Checklist: Compliance with safety and performance standards
• Risk Management File: Hazard analysis, mitigation plans, per Risk Management Guidance
• Test Reports: From CDSCO-approved labs (see Testing Laboratories)
• Labels and Instructions for Use (IFU): As per Indian regulatory requirements
• Quality Management System (QMS) Documents: ISO 13485 certification and internal procedures

Thorough documentation reduces delays and audit findings.

Import License Process (MD15) for Breast 3-D Infrared Imaging System

If you are importing this Class C device, the MD15 import license is mandatory. The process generally takes 5 to 6 months and involves:

1. Document Preparation: Gather required certificates including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.

2. License Application (Form MD14): File your application through the CDSCO MD Online Portal.

3. Query Resolution: Address any department queries swiftly.

4. License Grant: Receive the import license (Form MD15) for your products.

We recommend consulting our detailed Import License Guide for best practices.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate proving market authorization
• ISO 13485:2016 Certificate for quality management
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale Drug License if applicable
• Company Constitution and address proof

Timeline and Processing Duration

For import, expect approximately 5 to 6 months.

Government Fees and Costs

• MD9 Manufacturing License: INR 50,000 per application + INR 1,000 per product.
• Test License (MD13): Included in overall costs.
• Import License (MD15): For Class C/D devices, $3,000 per site +$1,500 per product.

Budget carefully for testing, audits, and consultancy services.

Common Challenges and Solutions

• Delayed Testing Results: Prioritize early submission to CDSCO-approved labs. Utilize the Testing Laboratories list to select the fastest accredited lab.

• Incomplete Documentation: Use our Device Master File Guide and Plant Master File Guide for comprehensive preparation.

• Audit Non-Compliance: Conduct internal pre-audits and gap assessments. Engage with notified bodies early; see the Notified Bodies List.

• Query Resolution Delays: Assign dedicated regulatory personnel to respond promptly and comprehensively.

Expert Consultation and Support

Navigating CDSCO’s regulatory landscape for advanced devices such as the Breast 3-D infrared imaging system requires expertise and attention to detail. Our consultancy has helped 500+ manufacturers and importers successfully obtain licenses by providing:

• Customized regulatory strategy
• Documentation review and gap analysis
• Liaison with CDSCO and notified bodies
• Training on QMS and audit preparedness

Engage with us early to streamline your approval process and avoid costly delays.

Getting Started with Your CDSCO License Application

1. Assess Your Manufacturing or Import Status: Decide if you are applying for MD9 (manufacturing) or MD15 (import).

2. Initiate Test License (MD13) Application: For manufacturers, submit the test license application on the CDSCO MD Online Portal.

3. Select Testing Laboratory: Choose an accredited government lab from the official list to conduct product testing.

4. Prepare Documentation: Use our guides on Device Master File and Plant Master File to compile comprehensive dossiers.

5. Engage Early with Notified Bodies: For manufacturing, schedule audits well in advance to fit within the 4-5 month timeline.

6. Submit License Application: File your Form MD7 (manufacturing) or MD14 (import) through the CDSCO portal.

7. Track Application Progress: Regularly monitor and respond to departmental queries.

By following these actionable steps and leveraging expert support, you can navigate the CDSCO licensing process efficiently and bring your Breast 3-D infrared imaging/vascular analysis system to the Indian market with confidence.

For further assistance, reach out to our regulatory team to schedule a consultation tailored to your product and business needs.