CDSCO License for Electronic clinical breast examination system

Electronic Clinical Breast Examination System: CDSCO Licensing Overview

The Electronic Clinical Breast Examination (CBE) System is an advanced medical device designed to electronically measure, map, document, and store critical diagnostic data about breast lesions, including shape, size, location, and tissue consistency during clinical breast exams. Classified under risk Class B and categorized within oncology devices, this portable system represents a significant development in breast cancer diagnostics.

Given its diagnostic role and intended use, securing the appropriate regulatory approval from the Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing this device in India. Compliance ensures not only legal market entry but also patient safety and quality assurance.

CDSCO Regulatory Framework for Electronic Clinical Breast Examination System

The CDSCO governs the import, manufacture, and sale of medical devices in India under the Medical Device Rules (MDR), 2017. Electronic CBE systems fall under Class B, meaning they pose moderate risk to patients and users.

For Class B devices, the relevant manufacturing license is the MD5 license, granted by the State Licensing Authority. The device must comply with the latest Medical Device Rules 2017 and the notification: File No. 29/Misc./03/2020-DC (153) — Part 1 dated 11.10.2022.

Manufacturers must follow a structured process including product testing in government-approved labs, documentation compliance, and audits by notified bodies.

Risk Classification and License Requirements

• Device Risk Class: B (Moderate risk)
• License Type Required: MD5 Manufacturing License (application via Form MD3)
• Licensing Authority: State Licensing Authority
• Audit: Conducted by a CDSCO notified body
• Testing: Mandatory testing at CDSCO-approved laboratories

Understanding this classification is crucial for preparing the correct application package and navigating regulatory timelines effectively. For detailed classification guidance, refer to the Medical Device Classification resource.

Manufacturing License Process (MD5) for Electronic CBE Systems

The MD5 license process involves several sequential steps:

1. Test License Application (Form MD13): Apply for a test license to manufacture the device for testing purposes. This is mandatory before product testing.
2. Product Testing: Submit samples to CDSCO-approved testing labs for compliance verification. Approved labs can be found on the CDSCO Testing Laboratories list.
3. Document Preparation: Compile detailed technical documentation including Device Master File and Plant Master File.
4. Application Submission (Form MD3): Submit the MD5 license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: The notified body performs a thorough inspection of manufacturing facilities and QMS.
6. Query Resolution: Address any questions or deficiencies raised during audit or review.
7. Grant of License (Form MD5): Upon successful compliance, the State Licensing Authority issues the MD5 manufacturing license.

For a deep dive into MD5 licensing, our MD5 License Guide offers step-by-step insights.

Manufacturing License Documents Required for Electronic CBE Systems

To ensure a smooth approval process, manufacturers must prepare the following critical documents:

• Company Constitution: Certificate of Incorporation, Memorandum & Articles of Association.
• Proof of Ownership or Lease Agreement: For manufacturing premises.
• Technical Staff Qualifications: CVs and certificates of key personnel.
• No Objection Certificates (NOCs): Fire safety and pollution control.
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process. Refer to our Device Master File Guide.
• Plant Master File (PMF): Documentation on manufacturing environment and quality controls. Learn more in our Plant Master File Guide.
• Essential Principles Compliance Checklist: Demonstrating adherence to safety and performance standards.
• Risk Management File: Documenting risk analysis and mitigation strategies. See our Risk Management resource.
• Test Reports: From CDSCO-approved labs confirming device compliance.
• Labels and Instructions for Use (IFU): Draft labels and user manuals.
• Quality Management System (QMS) Documents: ISO 13485 certification and associated SOPs.

Having these documents ready significantly reduces processing delays.

Import License Process (MD15) for Electronic CBE Systems

If you are an importer rather than a manufacturer, you will need to obtain an MD15 Import License from the Central Licensing Authority. The process includes:

1. Document Preparation: Including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device Master File, and Plant Master File.
2. Application Submission: Apply using Form MD14 via the CDSCO MD Online Portal.
3. Query Resolution: Respond to any CDSCO queries.
4. Issuance of MD15 License.

Note that unlike MD5 licensing, no test license is required for imports. However, the process can take 5-6 months due to thorough document verification.

For detailed guidance, visit our Import License Guide.

Import License Documents Required for Electronic CBE Systems

Key documents for import include:

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

Ensure all documents are current and notarized where necessary to avoid processing delays.

Timeline and Processing Duration

• MD5 Manufacturing License (Class B): Approximately 3-4 months total.

  • Test License (Form MD13): 1.5-2 months
  • Product Testing: 1 month
  • Application submission, audit, and queries: 1-1.5 months

• MD15 Import License: Approximately 5-6 months

Being proactive with document preparation and swift query resolution can significantly shorten these timelines.

Government Fees and Costs

• MD5 Manufacturing License Fees:

  • Rs 5,000 per application
  • Rs 500 per product (i.e., per device variant)

• MD15 Import License Fees (Class B):

  • $2,000 per site
  • $1,000 per product

Additional costs include testing fees at government-approved labs, audit fees payable to notified bodies, and costs related to document preparation and consultancy.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or improper QMS implementation.

Solution: Engage experienced consultants early, use our QMS documentation templates and ensure all technical files meet CDSCO standards.

Challenge: Difficulty in scheduling audits with notified bodies.

Solution: Check the latest list of notified bodies and book audits well in advance.

Challenge: Prolonged product testing timelines.

Solution: Choose CDSCO-approved testing labs with capacity and experience in oncology devices; consult our Testing Laboratories resource.

Expert Consultation and Support

With over 25 years of experience and having supported 500+ companies, we specialize in streamlining CDSCO licensing for oncology devices like the Electronic CBE system. Our team offers:

• Comprehensive gap analysis
• End-to-end document preparation
• Coordination with notified bodies
• Liaison with CDSCO authorities
• Timely query resolution and compliance support

Partnering with experts reduces risks of application rejection and accelerates market entry.

Getting Started with Your CDSCO License Application

1. Assess your device classification and confirm risk class B compliance.
2. Prepare technical documentation, including a detailed Device Master File and Plant Master File.
3. Apply for the test license (Form MD13) via the CDSCO MD Online Portal.
4. Select a CDSCO-approved testing laboratory to conduct product tests.
5. Schedule your audit with a notified body from the official list.
6. Compile and submit your manufacturing license application (Form MD3) online.
7. Respond promptly to CDSCO and auditor queries.

Taking these actionable steps methodically will set a solid foundation for regulatory approval. Reach out to our expert team today to initiate your licensing journey with confidence.