CDSCO License for Thoracic bioconductance measurement system
Medical Device Information
Intended Use
An assembly of devices designed to measure and store bioconductance measurements, analyse the stored data and provide information that can aid a clinician in their evaluation of lesions suspicious of lung cancer.
Comprehensive Guide to CDSCO Licensing for Thoracic Bioconductance Measurement Systems (Class B)
Navigating the regulatory landscape for cutting-edge medical devices like the Thoracic Bioconductance Measurement System requires precise knowledge and strategic planning. This device, designed to measure and analyze bioconductance data to assist clinicians in evaluating lung cancer lesions, falls under the Respiratory category and is classified as a Class B medical device by CDSCO. With over 25 years of expertise supporting 500+ companies in obtaining CDSCO licenses, we provide a detailed, actionable roadmap tailored for this device type.
Understanding the CDSCO Regulatory Framework for Thoracic Bioconductance Measurement Systems
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Devices intended for diagnostic and therapeutic purposes undergo risk-based classification, and licensing requirements vary accordingly. As a Class B device, the Thoracic Bioconductance Measurement System is considered low to moderate risk, requiring an MD5 manufacturing license issued by the State Licensing Authority.
The official notification relevant to this device is File No. 29/Misc/03/2020-DC(197) dated 6.8.2021, which classifies it under Class B and outlines compliance mandates.
Risk Classification and License Requirements for Class B Devices
Class B devices are categorized as low to moderate risk, necessitating compliance with essential principles of safety and performance. For such devices, the CDSCO mandates:
- Obtaining a Test License (Form MD13) before manufacturing.
- Undergoing product testing at government-approved laboratories.
- Submitting a comprehensive application for the Manufacturing License (Form MD3) leading to an MD5 license.
- Passing an audit by an approved notified body.
This process ensures the device meets all regulatory and quality standards before market entry.
Step-by-Step Manufacturing License Process (MD5) for Thoracic Bioconductance Systems
1. Apply for Test License (Form MD13):
Before manufacturing, the company must secure a test license for the device. This license allows limited production for testing purposes.
- Timeline: Approximately 1.5 to 2 months for approval.
- Key Actions: Prepare technical documents, quality management system details, and submit via the CDSCO MD Online Portal.
2. Product Testing:
Samples must be tested at government-approved labs to validate safety and performance.
- Refer to the List of Testing Laboratories for accredited facilities.
- Testing can take 1-2 months depending on lab schedules.
3. Documentation Preparation:
Compile all required documents such as Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, test reports, labels, and Instructions for Use (IFU).
4. Submit Manufacturing License Application (Form MD3):
Once test reports are favorable, apply for the MD5 license through the CDSCO MD Online Portal.
5. Audit by Notified Body:
An on-site audit is conducted by a CDSCO-approved notified body to verify compliance.
- Check the list of notified bodies for authorized auditors.
- Audit scheduling and report preparation typically take 4-6 weeks.
6. Resolution of Queries:
Respond promptly to any queries raised by the department or notified body to avoid delays.
7. Grant of MD5 License:
Upon successful audit and query clearance, the MD5 license is issued, authorizing manufacturing.
Essential Documents Required for MD5 License Application
- Company Constitution: Incorporation certificate, registration documents.
- Proof of Ownership of Premises: Lease or ownership documents.
- Technical Staff Details: Qualification and experience certificates.
- Fire and Pollution NOCs: Compliance certificates from local authorities.
- Device Master File (DMF): Detailed device design, specifications, manufacturing process (Device Master File guide).
- Plant Master File (PMF): Facility descriptions, quality systems (Plant Master File guide).
- Essential Principles Checklist: Compliance matrix.
- Risk Management File: Hazard analysis and mitigation (Risk Management).
- Test Reports: From approved labs.
- Labels and IFU: Device labeling and instructions.
- Quality Management System (QMS) Documents: ISO 13485 certifications and SOPs.
Import License Process (MD15) for Thoracic Bioconductance Measurement Systems
If importing this device into India, an MD15 import license issued by the Central Licensing Authority is required.
Key Steps:
- Prepare relevant documents including existing manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, DMF, PMF, wholesale license, and company constitution.
- Submit application using Form MD14 on the CDSCO MD Online Portal.
- Address any department queries promptly.
Timeline: Approximately 5-6 months.
Costs:
- Class B device import fees: 1000 per product.
Detailed Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License Approval | 1.5 - 2 months |
| Testing at Govt Approved Labs | 1 - 2 months |
| Document Preparation | 2 - 4 weeks |
| Application Submission & Audit | 1.5 - 2 months |
| Query Resolution & License Grant | 2 - 4 weeks |
Total Estimated Time: 3 to 4 months for MD5 license manufacturing process.
Government Fees and Cost Breakdown
- MD5 License: Rs 5,000 per application + Rs 500 per product.
- Test License (MD13): Included in application fees.
- Audit Fees: Typically borne by the manufacturer, varies by notified body.
Common Challenges and Practical Solutions
- Delays in Test Lab Scheduling: Book testing slots early and opt for labs with shorter backlogs.
- Incomplete Documentation: Use comprehensive checklists and expert review to avoid rejections.
- Audit Non-conformities: Conduct pre-audit internal reviews and corrective actions.
- Query Resolution Delays: Assign dedicated personnel for prompt communication with CDSCO.
Expert Consultation and Support
With decades of experience guiding over 500 companies through India's complex medical device regulatory environment, we offer:
- Personalized gap assessments for your Thoracic Bioconductance Measurement System.
- Assistance with DMF and PMF preparation.
- Liaison with notified bodies and labs.
- End-to-end application management on the CDSCO MD Online Portal.
Getting Started with Your CDSCO MD5 License Application
- Evaluate your device classification: Confirm Class B status and regulatory requirements.
- Prepare initial documentation: Focus on QMS, DMF, PMF, and risk files.
- Apply for Test License (Form MD13): Submit via CDSCO MD Online Portal.
- Schedule product testing: Coordinate with accredited testing laboratories early.
- Plan audit readiness: Engage with a notified body and conduct internal audits.
- Submit manufacturing license application (Form MD3): Complete with robust documentation.
- Prepare for audits and queries: Maintain transparent communication for swift resolution.
By following this detailed roadmap, manufacturers and importers can confidently approach the Indian market with compliance and operational excellence for the Thoracic Bioconductance Measurement System.
For tailored support and comprehensive guidance, explore our MD5 License Guide or contact our regulatory experts today.
