CDSCO License for Thoracic electrical impedance segmentography system

Comprehensive CDSCO Licensing Guide for Thoracic Electrical Impedance Segmentography System

Navigating the complex regulatory environment for medical devices in India requires precision, expertise, and up-to-date knowledge. As specialists with over 25 years of experience and having supported more than 500 companies in securing CDSCO licenses, we bring you an in-depth guide tailored to the Thoracic Electrical Impedance Segmentography System—a Class B respiratory device designed to assist in neonatal and infant lung ventilation diagnostics.

Understanding the Device: Thoracic Electrical Impedance Segmentography System

This system performs thoracic bio-impedance measurements and continuously records air distribution across four lung quadrants. It is primarily intended for neonatal and infant patients to detect regional changes in lung ventilation, aiding clinicians in diagnosing lung conditions. Classified as a Class B medical device under the CDSCO framework, it falls into the moderate risk category, requiring a State Licensing Authority-issued MD5 manufacturing license.

The device is officially notified under File No. 29/Misc/03/2020-DC(197), dated 6.8.2021, ensuring it is regulated within India’s specific medical device rules.

CDSCO Regulatory Framework for Class B Medical Devices

India’s Central Drugs Standard Control Organisation (CDSCO) regulates medical devices based on their risk classification. The Medical Device Rules, 2017, classify devices from Class A (low risk) to Class D (high risk). Class B devices, including your thoracic impedance system, require adherence to specific licensing and quality management mandates.

This regulatory framework ensures safety, efficacy, and quality, vital for devices used in vulnerable populations such as neonates.

Risk Classification and License Requirements for Your Device

Your thoracic electrical impedance segmentography system is a Class B device, which mandates an MD5 manufacturing license granted by the State Licensing Authority. This license confirms compliance with both manufacturing and quality requirements.

The licensing process involves several steps: obtaining a test license (MD13), product testing at government-approved labs, documentation preparation, submission of manufacturing license application (Form MD3), inspection/audit by notified bodies, and finally, license grant (Form MD5).

Manufacturing License Process (MD5) for Class B Devices

1. Test License Acquisition (Form MD13): Before manufacturing, you must secure a test license. This allows limited production to facilitate product testing.
2. Product Testing: Conducted at CDSCO-approved testing laboratories to validate device safety and performance. Refer to the Testing Laboratories list.
3. Documentation Preparation: Assemble the Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, Quality Management System (QMS) documents, labels, and Instructions for Use (IFU).
4. License Application Submission: Submit Form MD3 via the CDSCO MD Online Portal.
5. Audit by Notified Body: As per the Notified Bodies list, an audit verifies compliance with manufacturing and quality standards.
6. Queries Resolution: Address any observations or queries raised by the licensing authority or notified body promptly.
7. License Grant: Upon successful completion, receive the MD5 license to manufacture your Class B device legally in India.

Manufacturing License Documents Required

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of ownership/lease of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing device design and specifications. Our detailed Device Master File guide can assist you.
• Plant Master File (PMF) describing manufacturing facilities and processes. Learn more in our Plant Master File guide.
• Essential Principles Checklist confirming compliance with Indian regulatory standards
• Risk Management File addressing potential hazards and mitigation strategies. For comprehensive insights, visit our Risk Management guide.
• Product Test Reports from government-approved labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Import License Process (MD15) for Thoracic Electrical Impedance Segmentography Systems

If you intend to import this Class B device into India, you must obtain an MD15 import license through the Central Licensing Authority. The process includes:

• Document preparation including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
• Application submission on the CDSCO MD Online Portal.
• Departmental review and queries resolution.
• License grant on Form MD15.

Note that unlike manufacturing licenses, no test license is required for import applications.

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3-4 months total. This includes 1.5-2 months for test license acquisition and product testing, followed by documentation, audit, queries, and license issuance.
• MD15 Import License: Typically takes 5-6 months due to thorough document review.

Government Fees and Costs

For Class B devices such as your thoracic electrical impedance system, fees are as follows:

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product.
• MD15 Import License: $2,000 per site +$1,000 per product.

Budgeting for testing, audit, and potential consultancy fees is also essential for a smooth application process.

Common Challenges and Practical Solutions

• Delays in Test License Approval: Early submission and clear documentation can reduce waiting times.
• Incomplete or Non-compliant Documentation: Utilize templates and expert checklists to ensure all files meet CDSCO standards.
• Audit Non-conformities: Pre-audit internal reviews by experienced consultants can prevent costly delays.
• Product Testing Failures: Engage with accredited labs early and perform internal testing to identify issues beforehand.

Our experience shows that proactive communication with CDSCO and timely response to queries significantly expedite approvals.

Expert Consultation and Support

We recommend partnering with regulatory consultants experienced in Class B respiratory devices to navigate the nuances of CDSCO licensing. Our team offers:

• Comprehensive document preparation assistance
• Coordination with notified bodies and testing labs
• Audit readiness support
• Post-approval compliance monitoring

Leveraging expert advice minimizes risk and accelerates market entry.

Getting Started with Your CDSCO License Application

To initiate your licensing process for the Thoracic Electrical Impedance Segmentography System:

1. Register on the CDSCO MD Online Portal.
2. Prepare and submit your Test License (Form MD13) application.
3. Engage a CDSCO-approved testing laboratory early to schedule product testing.
4. Begin compiling your Device Master File and related documentation using our expert guides.
5. Identify a notified body from the official list for your audit.
6. Plan for internal audits and quality checks to ensure compliance.
7. Submit the manufacturing license application (Form MD3) post-successful testing and audit preparation.

By following these structured steps and leveraging our extensive industry experience, manufacturers and importers can efficiently secure CDSCO licensing for this crucial neonatal respiratory diagnostic device and confidently enter the Indian healthcare market.