CDSCO License for General- purpose ultrasound imaging system

Comprehensive CDSCO Licensing Guide for General-Purpose Ultrasound Imaging Systems (Class B)

As seasoned regulatory consultants with over 25 years of experience helping 500+ medical device companies navigate the CDSCO licensing maze, we understand the intricacies involved in bringing a Class B medical device like the general-purpose ultrasound imaging system to the Indian market. This device, primarily used in interventional radiology for diagnostic imaging across multiple specialties such as cardiac, OB/GYN, and intra-surgical applications, demands strict adherence to the CDSCO regulatory framework to ensure safety, efficacy, and compliance.

Understanding Your Device: General-Purpose Ultrasound Imaging System

Your device is classified under Risk Class B as per CDSCO guidelines, reflecting a moderate risk level due to its intended use in extracorporeal and intracorporeal ultrasound imaging procedures. This classification impacts the regulatory pathway, documentation, fees, and timelines, making it essential to have a clear grasp of these details before initiating your application.

CDSCO Regulatory Framework for Class B Medical Devices

India's Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing under the Medical Device Rules, 2017. For Class B devices like yours, the licensing authority is the State Licensing Authority, and the applicable manufacturing license is the MD5 license. All applications, including manufacturing and import licenses, are submitted and tracked through the CDSCO MD Online Portal.

Risk Classification and License Requirements for Your Device

Your general-purpose ultrasound imaging system falls into Class B based on the device’s intended use and associated risks. This classification mandates:

• Manufacturing License: MD5 (Form MD3 application)
• Test License: MD13 (mandatory before MD5 application)
• Auditing: Conducted by a notified body from CDSCO’s Notified Bodies List

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process unfolds in several stages:

1. Test License Application (Form MD13): Submit your test license application to the State Licensing Authority. This license permits you to manufacture the device on a trial basis solely for testing.
2. Product Testing: Get your ultrasound imaging system tested at government-approved labs listed on the Testing Laboratories page. The testing duration usually takes 4-6 weeks.
3. Document Preparation: Compile essential documentation including technical, quality management, and compliance files.
4. MD5 License Application (Form MD3): Submit the manufacturing license application with all supporting documents.
5. Audit by Notified Body: An on-site audit reviews your manufacturing processes, quality systems, and compliance.
6. Queries and Clarifications: Address any queries raised by the State Licensing Authority or the notified body promptly.
7. Grant of MD5 License: Upon successful review and audit, the State Licensing Authority issues the manufacturing license (Form MD5).

Key Manufacturing License Documents Required

For your ultrasound imaging system, the following documents are mandatory:

• Company Constitution: Incorporation certificate, Articles of Association
• Proof of Ownership or Lease of Premises: Valid documents proving manufacturing site ownership or lease
• Technical Staff Details: Qualifications and experience certificates of key personnel
• Fire NOC and Pollution Control Board NOC: Compliance certificates
• Device Master File (DMF): Detailed device design, specifications, and manufacturing process – see our Device Master File Guide
• Plant Master File (PMF): Description of manufacturing facilities and quality controls – learn more in our Plant Master File Guide
• Essential Principles Checklist: Evidence of compliance with medical device essential principles
• Risk Management File: Comprehensive risk assessment and mitigation for the device – refer to our Risk Management resource
• Test Reports: Certificates from CDSCO-approved labs
• Labels and Instructions for Use (IFU): Device labeling and user manuals
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal quality processes

Import License Process (MD15) for General-Purpose Ultrasound Imaging Systems

For importers of your Class B device, the process to obtain an MD15 license involves:

1. Document Preparation: Assemble all required import documents including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, and quality files.
2. Application Submission: File the application using Form MD14 on the CDSCO MD Online Portal.
3. Query Resolution: Respond to any departmental queries.
4. Grant of Import License: The Central Licensing Authority issues the MD15 license.

Import License Documents Required

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

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3-4 months total

  • Test License (MD13): 1.5-2 months
  • Product Testing: 1-1.5 months
  • Audit & Query Resolution: 1-1.5 months

• MD15 Import License: Approximately 5-6 months

These timelines may vary based on the completeness of your application and audit scheduling.

Government Fees and Costs

• MD5 Manufacturing License:

  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

• MD15 Import License:

  • For Class B devices, the fee is approximately $2,000 per site and$1,000 per product (in INR equivalent)

Budgeting for testing fees, notified body audits, and consultancy is also critical.

Common Challenges and Practical Solutions

• Delayed Test Reports: Proactively coordinate with government-approved labs to expedite testing. Use labs from the CDSCO Testing Laboratories list with proven turnaround times.
• Incomplete Documentation: Engage regulatory experts early to prepare comprehensive Device and Plant Master Files and risk management documents.
• Audit Non-Compliance: Conduct internal mock audits before notified body visits to identify gaps.
• Query Management: Maintain a dedicated regulatory liaison to promptly address CDSCO queries.

Expert Consultation and Support

Navigating the CDSCO licensing process for your general-purpose ultrasound imaging system can be complex but manageable with expert guidance. Our team has successfully supported over 500 companies with end-to-end regulatory services including document preparation, audit support, and submission management. We specialize in ensuring timely approvals while minimizing compliance risks.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm your device’s classification on Medical Device Classification.
2. Prepare Test License Application: Use Form MD13 on the CDSCO MD Online Portal to initiate your test license.
3. Identify Notified Body: Select from CDSCO’s list to schedule your audit.
4. Compile and Review Documentation: Use our Device Master File and Plant Master File guides to finalize your technical files.
5. Plan Testing: Coordinate with government-approved labs for product testing.
6. Submit Manufacturing License Application: Apply on the portal with completed documents.
7. Engage with CDSCO: Respond to queries with clear, documented evidence.

Embarking on this journey with a clear roadmap ensures you meet all regulatory requirements efficiently, positioning your general-purpose ultrasound imaging system for successful entry into the Indian healthcare market.

For personalized assistance and to discuss your specific regulatory needs, please contact our experienced team. We are here to help you every step of the way.