CDSCO License for Hepatic ultrasound elastography system applicator

Comprehensive Guide to CDSCO Licensing for Hepatic Ultrasound Elastography System Applicator (Class B Device)

Navigating the regulatory landscape for medical devices in India requires precise knowledge and experience, especially for specialized devices like the Hepatic Ultrasound Elastography System Applicator. As a trusted regulatory consultant with over 25 years of expertise and having successfully assisted more than 500 companies, we provide you with detailed, actionable insights on obtaining your CDSCO license efficiently.

Understanding the Hepatic Ultrasound Elastography System Applicator and Its Regulatory Importance

The Hepatic Ultrasound Elastography System Applicator is a sophisticated, non-sterile, hand-held device designed for transcutaneous measurement of liver stiffness, crucial for diagnosing liver pathologies. It combines ultrasound and electrodynamic transducers to generate and measure elastic shear waves through the skin and liver tissue.

Given its medical significance, especially in pediatrics and neonatology, and its reusable nature, this device is classified as Class B under CDSCO regulations. Compliance ensures market access while guaranteeing patient safety and device performance.

CDSCO Regulatory Framework for Class B Medical Devices

Class B devices are considered low to moderate risk. The regulatory authority mandates manufacturers to acquire an MD5 manufacturing license from the State Licensing Authority. This license confirms that your manufacturing processes, quality systems, and product safety meet Indian regulatory standards.

Risk Classification and License Requirements for Hepatic Ultrasound Elastography System Applicator

• Risk Class: B (Low-Moderate Risk)
• License Type: MD5 (Form MD3 application)
• Authority: State Licensing Authority
• Regulation Basis: Medical Device Rules, 2017 under the Drugs and Cosmetics Act

For detailed risk classification, you may refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Device

The MD5 license process involves several critical steps:

1. Test License Application (Form MD13): Obtain a test license to manufacture the device for testing purposes. This typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing at CDSCO-approved government laboratories. Testing includes evaluating safety, efficacy, and performance parameters specific to hepatic ultrasound elastography systems.

3. Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.

4. Submission of Manufacturing License Application (Form MD3): Apply for the MD5 license through the CDSCO MD Online Portal.

5. Audit by Notified Body: Undergo a manufacturing site audit performed by a notified body listed on the CDSCO Notified Bodies List.

6. Resolution of Queries: Address any queries or deficiencies raised by the licensing authority or notified body.

7. License Grant: Upon satisfactory compliance, the MD5 license is granted, enabling full-scale manufacturing and marketing in India.

For a detailed walkthrough, our MD5 License Guide offers valuable insights.

Manufacturing License Documents Required

For your Hepatic Ultrasound Elastography System Applicator, ensure submission of the following:

• Company Constitution/Registration documents
• Proof of Ownership or Lease deed of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing device design, specifications, and manufacturing process (see our DMF Guide)
• Plant Master File (PMF) describing infrastructure and equipment (PMF Guide)
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File demonstrating hazard identification, risk analysis, and mitigation (Risk Management resource)
• Valid Test Reports from CDSCO-recognized labs (Testing Laboratories list)
• Labels and Instructions for Use (IFU) complying with Indian regulations
• Quality Management System documentation (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Hepatic Ultrasound Elastography System Applicator

If you are an importer, the MD15 license is mandatory and granted by the Central Licensing Authority. The process includes:

• Preparing documentation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and Wholesale License.
• Submitting application on Form MD14 via the CDSCO MD Online Portal.
• Responding to departmental queries.
• License issuance typically takes 5 to 6 months.

For detailed steps, refer to our Import License Guide.

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): Nominal fees as per state regulations
• MD5 License Application: Rs. 5,000 per application
• Product Fees: Rs. 500 per product
• Additional Costs: Notified body audit fees (varies), testing laboratory charges (varies)

Budgeting realistically for these costs and timelines can prevent unexpected delays.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all documents are meticulously prepared and aligned with CDSCO guidelines to avoid rejection.
• Delayed Testing: Pre-book slots at government-approved labs early to prevent bottlenecks.
• Audit Non-Compliance: Conduct internal audits and pre-audit checks with consultants before notified body visits.
• Query Management: Respond promptly and comprehensively to CQRs (Common Queries Raised) from CDSCO.

Expert Consultation and Support

Our extensive experience with over 500 successful CDSCO applications positions us uniquely to guide you through:

• Device classification and categorization
• Customized document preparation
• Liaison with notified bodies and testing labs
• Audit readiness and compliance
• Efficient query resolution

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class B status using the CDSCO framework.
2. Prepare Your Test License Application: Begin with Form MD13 submission on the CDSCO MD Online Portal.
3. Arrange Product Testing: Schedule testing at CDSCO-recognized labs early.
4. Compile Required Documentation: Use our Device Master File and Plant Master File guides to ensure completeness.
5. Plan for Audit: Select a notified body from the official list and prepare your manufacturing site accordingly.
6. Submit MD5 Application (Form MD3): After successful testing and documentation preparation.
7. Engage with Us: For tailored support, ensuring timely approvals and smooth market entry.

Embarking on your CDSCO licensing journey for the Hepatic Ultrasound Elastography System Applicator is manageable with the right partner and strategy. Contact us to leverage our 25+ years of regulatory expertise and secure your license efficiently.