CDSCO License for Intubation laryngoscope
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation.
Introduction to Intubation Laryngoscope and Regulatory Importance
The intubation laryngoscope is a critical anesthesiology device used by anesthesia and emergency personnel to facilitate airway management. This hand-held instrument helps manipulate the tongue, ensuring a clear view of the trachea for endotracheal tube insertion—an essential step before delivering inhalational anesthesia or mechanical ventilation. Given its direct impact on patient safety and life-support procedures, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing this device in India.
At our consultancy, with over 25 years of experience and 500+ successful CDSCO licensing projects, we understand the nuances of navigating India’s regulatory landscape for Class A medical devices like the intubation laryngoscope. This comprehensive guide will walk you through the entire process—from classification to license issuance—providing actionable insights and practical tips tailored for your device.
CDSCO Regulatory Framework for Intubation Laryngoscope
The CDSCO regulates all medical devices under the Medical Device Rules, 2017. The intubation laryngoscope falls under Class A (low risk) as per the official notification 29/Misc/03/2020-DC(177), dated July 12, 2021, categorizing anesthesiology devices.
Class A devices are regulated primarily by the State Licensing Authority and require a manufacturing license (MD5) for local production, or an import license (MD15) if sourced internationally. The framework mandates adherence to quality management systems and compliance with essential principles of safety and performance.
Risk Classification and License Requirements for Intubation Laryngoscope
Risk Class: A (Low Risk)
License Type: MD5 Manufacturing License
Governing Authority: State Licensing Authority
Process Duration: Approximately 3 to 4 months
Fees: ₹5,000 per application + ₹500 per product
Understanding your device’s risk classification is crucial. The intubation laryngoscope, being Class A, benefits from a relatively streamlined regulatory process. However, compliance with documentation, testing, and audit requirements remains mandatory.
Manufacturing License Process for Class A Intubation Laryngoscope (MD5)
Test License Application (Form MD13): Before applying for the MD5 license, manufacturers must secure a test license to produce the device sample for testing. This step typically takes 1.5 to 2 months and includes submission of limited documents.
Product Testing: Upon receiving the test license, samples must be tested at CDSCO-approved laboratories. For your convenience, review the list of government-approved testing laboratories.
Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, essential principles checklist, quality management system (QMS) documents, and others detailed below.
Filing Manufacturing License Application (Form MD3): Submit the MD5 application via the CDSCO MD Online Portal along with fees.
Audit by Notified Body: A mandatory audit by a CDSCO-recognized notified body will be conducted to verify compliance. Refer to the notified bodies list for selecting the auditor.
Resolution of Queries: Respond promptly to any queries or deficiencies highlighted by the licensing authority or notified body.
License Grant (Form MD5): Upon satisfactory compliance, the manufacturing license will be granted.
For a detailed walkthrough, our MD5 License Guide offers practical insights.
Manufacturing License Documents Required for Intubation Laryngoscope
Successful application hinges on meticulous documentation. For the intubation laryngoscope, you must prepare:
- Company Constitution: Certificate of incorporation, partnership deed, or equivalent.
- Proof of Premises Ownership or Lease: Legal documents verifying manufacturing site.
- Technical Staff Details: Qualifications and experience of personnel responsible for manufacturing.
- Fire NOC and Pollution Control NOC: Compliance certificates from relevant authorities.
- Device Master File (DMF): Detailed device specifications, design, manufacturing process, and testing protocols. Learn how to create a Device Master File.
- Plant Master File (PMF): Infrastructure, equipment details, and processes of your manufacturing site. Our Plant Master File Guide can assist.
- Essential Principles Checklist: Confirming compliance with CDSCO’s safety and performance requirements.
- Risk Management File: Documentation of risk analysis, mitigation strategies, and validation. See our Risk Management resource.
- Test Reports: From CDSCO-approved labs confirming device safety and efficacy.
- Labels and Instructions for Use (IFU): As per regulatory standards.
- Quality Management System (QMS) Documents: Including SOPs, corrective and preventive action (CAPA), and internal audit reports.
Import License Process for Intubation Laryngoscope (MD15)
While the intubation laryngoscope is Class A, manufacturers or distributors opting for import require an MD15 license issued by the Central Licensing Authority.
Key steps include:
Document Preparation: Collect required documents such as a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device and Plant Master Files, and company constitution.
Application Submission: File Form MD14 for import license application on the CDSCO MD Online Portal.
Review and Queries: Address any departmental queries promptly.
Grant of License: Typically takes 5 to 6 months.
The import license fees vary by risk class. For Class A devices, expect approximately 50 per product.
For detailed import guidance, see our Import License Guide.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale license (if applicable)
- Company Constitution documents
Timeline and Processing Duration
| License Type | Timeline |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| MD5 Manufacturing License (MD3) | 3 – 4 months total* |
| MD15 Import License | 5 – 6 months total |
*The MD5 timeline includes test license, testing, audit, and query resolution.
Government Fees and Costs
- MD5 Manufacturing License: ₹5,000 per application + ₹500 per product
- MD15 Import License: For Class A devices, approximately 50 per product
Budgeting accurately helps avoid delays caused by payment issues.
Common Challenges and Solutions
Challenge: Delays in testing due to limited slots in government-approved labs.
Solution: Schedule testing early and consider multiple approved laboratories. Review the Testing Laboratories list.
Challenge: Incomplete or inconsistent documentation leading to query overload.
Solution: Use checklists and expert reviews to ensure all documents—especially DMF and PMF—are thorough and compliant.
Challenge: Audit non-compliance with QMS or infrastructure gaps.
Solution: Conduct internal audits and mock inspections before notified body audits.
Challenge: Unclear regulatory interpretations causing application rejection.
Solution: Engage experienced regulatory consultants to interpret guidelines and prepare submissions.
Expert Consultation and Support
With our extensive experience assisting over 500 medical device companies, we offer tailored support for intubation laryngoscope manufacturers and importers. From document preparation, audit readiness, to application filing on the CDSCO MD Online Portal, our team ensures a smooth, timely approval process.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm your device’s Class A status using CDSCO’s classification guidelines.
Initiate Test License Application: Prepare initial documents and apply for the test license (Form MD13) on the CDSCO portal.
Plan Testing Schedule: Coordinate with approved testing labs to avoid bottlenecks.
Develop Comprehensive Documentation: Gather and prepare all required files, leveraging our guides on Device Master Files and Plant Master Files.
Engage a Notified Body: Select a notified body from the official list early to schedule your audit.
Submit Manufacturing License Application (Form MD3): File your application online and track its progress.
Prepare for Queries and Audit: Be responsive and maintain readiness for audit visits.
Taking these practical steps will position your intubation laryngoscope for successful entry into the Indian market with full regulatory compliance.
For personalized assistance and a step-by-step roadmap tailored to your manufacturing or import scenario, contact us today to leverage our 25+ years of CDSCO licensing expertise.
