CDSCO License for Echocardiograph

Comprehensive Guide to CDSCO Licensing for Echocardiograph (Class B Cardiovascular Device)

Echocardiographs are sophisticated medical devices that utilize ultrasonic energy to generate precise images of cardiovascular structures, including phased arrays and two-dimensional scanners. Given their critical role in cardiac diagnostics, these devices fall under Class B risk according to the CDSCO classification system. Navigating the regulatory landscape for such devices in India requires meticulous preparation and understanding of the CDSCO licensing framework.

With over 25 years of experience assisting 500+ manufacturers and importers, we provide you with an authoritative and actionable roadmap to secure your CDSCO license efficiently.

CDSCO Regulatory Framework for Echocardiograph

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Since the notification 29/Misc./03/2020-DC (159) dated 26th July 2021, echocardiographs are regulated as Class B devices under the cardiovascular category. This classification mandates compliance with specific licensing procedures, quality management standards, and testing requirements.

The regulatory pathway involves obtaining a Manufacturing License (MD5) for local production or an Import License (MD15) for bringing the device into India.

Risk Classification and License Requirements for Echocardiograph

• Device: Echocardiograph
• Risk Class: B (Low-moderate risk)
• Regulatory License: MD5 Manufacturing License (Form MD3)
• Issuing Authority: State Licensing Authority
• Process Timeline: 3-4 months
• Fees: Rs 5,000 application + Rs 500 per product

Class B devices like echocardiographs require a thorough conformity assessment including product testing and quality system audits before license issuance.

Manufacturing License Process (MD5) for Echocardiograph

The MD5 license process for Class B devices is a multi-step procedure:

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

2. Product Testing: Get the echocardiograph tested at a CDSCO-approved government laboratory to verify compliance with Essential Principles and safety standards. Utilize the official list of testing laboratories for selection.

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

4. Application Submission: Submit the MD5 license application (Form MD3) via the CDSCO MD Online Portal along with supporting documents and fees.

5. Audit by Notified Body: The State Licensing Authority will coordinate an audit by a CDSCO-notified body. Refer to the Notified Bodies List for accredited auditors.

6. Query Resolution: Address any queries or requests for clarifications raised by the department or notified body promptly.

7. License Grant: Upon satisfactory completion of all requirements, the MD5 license will be granted on Form MD5.

For detailed guidance, our MD5 License Guide provides extensive insights.

Manufacturing License Documents Required for Echocardiograph

To streamline your application, ensure you have the following documents ready:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing device specifications and design (Guide here)
• Plant Master File (PMF) describing manufacturing processes (Guide here)
• Essential Principles Compliance Checklist
• Risk Management File complying with ISO 14971 standards (Risk Management Guide)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Ensuring completeness and accuracy here will expedite your review process.

Import License Process (MD15) for Echocardiograph

If you are importing an echocardiograph, the MD15 import license from the Central Licensing Authority is required. The process is as follows:

1. Document Preparation: Gather all manufacturing license documents from the country of origin, including Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master and Plant Master Files, and Wholesale License.

2. Application Submission: File your application using Form MD14 on the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any clarifications from the CDSCO.

4. License Grant: The import license is issued on Form MD15, generally within 5-6 months.

Note: Test license and product testing are not mandatory for imports but having comprehensive documentation is critical.

Our Import License Guide can help you navigate this process.

Import License Documents Required for Echocardiograph

• 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 in India
• Company Constitution Documents

Timeline and Processing Duration

For imports, expect approximately 5-6 months due to centralized processing.

Government Fees and Costs

For manufacturing an echocardiograph (Class B):

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

Additional costs include product testing fees at CDSCO-approved labs (vary by lab and testing scope) and notified body audit charges (customarily negotiated).

For import licenses, fees are higher and scaled by risk class.

Common Challenges and Solutions

• Incomplete Documentation: Avoid delays by preparing Device and Plant Master Files meticulously. Use expert templates and guides.
• Delayed Testing: Coordinate early with approved labs to book testing slots.
• Audit Readiness: Conduct internal pre-audits to ensure compliance with QMS and manufacturing practices.
• Query Management: Designate a regulatory lead to respond to CDSCO queries within stipulated timelines to prevent process stagnation.

Expert Consultation and Support

Our consultancy has supported over 500 companies through the CDSCO maze, delivering end-to-end assistance from documentation to audit facilitation. Leveraging our deep understanding of CDSCO protocols ensures:

• Tailored Device Master File and Plant Master File preparation
• Efficient liaison with notified bodies and testing labs
• Proactive risk management and Essential Principles compliance
• Timely application and query management

Getting Started with Your CDSCO License Application for Echocardiograph

1. Identify Your License Type: For manufacturing, start with the MD5 license pathway.
2. Register on the CDSCO MD Online Portal: Create your organizational profile.
3. Initiate Test License Application (MD13): Submit initial documents and await approval.
4. Plan Product Testing: Coordinate with a CDSCO-approved lab early.
5. Compile Documentation: Use our checklists to prepare DMF, PMF, Risk Management file, QMS documents.
6. Schedule Internal Audit: Verify compliance before notified body audit.
7. Submit MD5 Application (Form MD3): Upload all documents and pay fees via the portal.
8. Prepare for Notified Body Audit: Ensure manufacturing premises and processes meet CDSCO standards.
9. Monitor Application: Respond quickly to any CDSCO or auditor queries.

Embarking on this process with systematic planning and expert guidance will maximize your chances of timely license approval, enabling your echocardiograph to enter the Indian market compliantly and competitively.