CDSCO License for Endotracheal secretion monitoring system
Medical Device Information
Intended Use
An assembly of devices designed to continuously detect the sound of endotracheal (ET) secretions moving through a ventilation circuit during suctioning of an artificially ventilated and/or spontaneously breathing patient to assess the effectiveness of suctioning.
Comprehensive Guide to CDSCO Licensing for Endotracheal Secretion Monitoring Systems
As specialists with over 25 years of experience and having supported more than 500 medical device companies, we understand the regulatory journey for innovative devices like the Endotracheal Secretion Monitoring System. This device, classified under risk Class B and categorized under anesthesiology, plays a vital role in enhancing patient care by continuously monitoring endotracheal secretions during ventilation. Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process is critical for market entry in India, ensuring compliance, safety, and quality.
CDSCO Regulatory Framework for Endotracheal Secretion Monitoring Systems
This device falls under the purview of CDSCO’s medical device regulations as notified under the Gazette Notification 29/Misc/03/2020-DC(177) dated 12.07.2021. As a Class B device, it is considered low to moderate risk, requiring a manufacturing license (MD5) issued by the State Licensing Authority. Regulatory compliance encompasses device testing, audits by notified bodies, and thorough documentation to demonstrate adherence to essential principles and quality management standards.
Risk Classification and License Requirements
Endotracheal Secretion Monitoring Systems are classified as Class B under CDSCO guidelines due to their role in patient monitoring during anesthesia and ventilation.
- License Type: MD5 (Manufacturing License for Class A/B devices)
- Regulatory Authority: State Licensing Authority
- Application Form: MD3
This classification demands a structured process including a test license (MD13), product testing at CDSCO-approved laboratories, an audit by a notified body, and submission of extensive documentation.
Manufacturing License Process (MD5)
The MD5 license process typically spans 3 to 4 months and involves several key steps:
- Test License (MD13) Application: Initiate with applying for a test license to legally manufacture and test the device prototype, which takes approximately 1.5 to 2 months.
- Product Testing: Conduct mandatory product testing at government-approved laboratories recognized by CDSCO. This ensures the device meets safety and performance standards.
- Documentation Preparation: Compile critical documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
- License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
- Audit by Notified Body: Undergo an on-site audit by a notified body listed by CDSCO to verify compliance.
- Resolution of Queries: Address any queries or observations raised by the licensing authority or notified body.
- Grant of License: Upon successful compliance, the MD5 license is granted in Form MD5.
For detailed audit requirements, consult the list of notified bodies.
Manufacturing License Documents Required
To streamline your application, ensure the following documents are meticulously prepared:
- Company Constitution (e.g., Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualification Certificates of Technical Staff
- Fire and Pollution NOCs
- Device Master File (DMF) – comprehensive device specifications and design details (Device Master File Guide)
- Plant Master File (PMF) – manufacturing environment and infrastructure details (Plant Master File Guide)
- Essential Principles Checklist
- Risk Management File – demonstrating risk assessment and mitigation strategies (Risk Management Guide)
- Test Reports from CDSCO-approved labs (Testing Laboratories)
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (ISO 13485:2016 compliance preferred)
Import License Process (MD15)
For manufacturers or importers seeking to bring the Endotracheal Secretion Monitoring System into India, an Import License (MD15) issued by the Central Licensing Authority is mandatory. The process includes:
- Document preparation including Manufacturing License, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files.
- Submission of application through the CDSCO MD Online Portal using Form MD14.
- Resolution of any department queries.
- License grant typically occurs within 5 to 6 months.
Note that a test license is not required for import applications.
Import License Documents Required
Key documents for MD15 application include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate confirming market approval
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Process Step | Estimated Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 6 weeks |
| Document Preparation | 2 - 3 weeks |
| License Application (MD3) | Immediate upon readiness |
| Audit by Notified Body | Scheduled within 4 weeks |
| Query Resolution | 2 - 4 weeks |
| Grant of MD5 License | Total 3 - 4 months |
For import license (MD15), expect 5 to 6 months from submission to approval.
Government Fees and Costs
- MD5 Manufacturing License: Rs 5,000 application fee + Rs 500 per product
- MD15 Import License: Fees vary by class; for Class B devices, typically Rs 2,000 per site and Rs 1,000 per product
These fees are payable online during application submission through the CDSCO portal.
Common Challenges and Solutions
Challenge: Delays in product testing due to laboratory backlogs.
Solution: Pre-schedule testing with CDSCO-approved labs and maintain open communication. Utilizing labs listed on the Testing Laboratories page helps ensure credibility.
Challenge: Incomplete or inconsistent documentation leading to application rejection.
Solution: Engage experienced regulatory consultants to review documentation against CDSCO requirements and leverage templates from our Device Master File Guide.
Challenge: Audit non-compliance findings.
Solution: Conduct internal audits aligned with notified body criteria prior to formal audits, and address gaps proactively.
Expert Consultation and Support
With our 25+ years of regulatory consulting expertise, we provide end-to-end support:
- Tailored documentation preparation and review
- Coordination with CDSCO-approved testing laboratories and notified bodies
- Guidance on regulatory updates and compliance strategies
- Application submission and follow-up services
Our proven track record with over 500 companies ensures you avoid common pitfalls and achieve timely approvals.
Getting Started with Your CDSCO License Application
To initiate your CDSCO MD5 license for the Endotracheal Secretion Monitoring System:
- Assess your device classification and licensing route using the Medical Device Classification guidelines.
- Prepare and submit Test License (MD13) application through the CDSCO MD Online Portal.
- Plan product testing with a government-approved laboratory.
- Develop comprehensive documentation including DMF, PMF, risk management files, and QMS.
- Apply for MD5 license (Form MD3) once test license and testing are complete.
- Coordinate audit scheduling with notified bodies listed on the CDSCO site.
- Respond promptly to queries from regulatory authorities to expedite approval.
Starting early and maintaining clear communication with all stakeholders is essential. Contact us to leverage our expertise and fast-track your compliance journey.
By following this stepwise, well-informed approach, manufacturers and importers of Endotracheal Secretion Monitoring Systems can confidently enter the Indian market with full regulatory compliance and minimal delays.
