CDSCO License for Rigid non-bladed video intubation laryngoscope

Comprehensive Guide to CDSCO Licensing for Rigid Non-Bladed Video Intubation Laryngoscope (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and more than 500 successful CDSCO license applications, we understand the nuances involved in bringing innovative medical devices like the rigid non-bladed video intubation laryngoscope to the Indian market. This Class A anesthesiology device plays a critical role in facilitating endotracheal tube positioning during anesthesia and ventilation. Navigating the Central Drugs Standard Control Organisation (CDSCO) regulatory framework effectively is essential for manufacturers and importers to ensure compliance and timely market access.

CDSCO Regulatory Framework for Rigid Non-Bladed Video Intubation Laryngoscope

The rigid non-bladed video intubation laryngoscope falls under Class A medical devices as per the CDSCO classification, designated under anesthesiology devices. Our reference for this classification aligns with the CDSCO Medical Device Classification.

Class A devices are considered low risk, and the licensing authority for manufacturing is the State Licensing Authority. The regulatory process mandates adherence to the Medical Device Rules 2017, alongside the standards and notifications specific to anesthesiology instruments.

Risk Classification and License Requirements

• Device Name: Rigid non-bladed video intubation laryngoscope
• Risk Class: Class A (Low Risk)
• Intended Use: Non-sterile device to assist in positioning endotracheal tubes
• License Type: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority

For Class A devices, the MD5 license process includes obtaining a Test License (Form MD13), product testing through government-approved laboratories, followed by an audit by a notified body.

Manufacturing License Process (MD5)

The MD5 license is a multi-step process taking approximately 3 to 4 months from start to finish:

1. Test License (MD13) Application: Submit through the CDSCO MD Online Portal to obtain permission for product testing.
2. Product Testing: Conduct testing at government-approved labs listed on the CDSCO portal (Testing Laboratories).
3. Document Preparation: Compile required technical and quality documentation.
4. Apply for Manufacturing License (MD5) using Form MD3: Complete and submit the application via the online portal.
5. Audit by Notified Body: Coordinate with an approved notified body from the Notified Bodies List for facility inspection.
6. Queries Resolution: Address any observations or queries from the licensing authority or notified body.
7. Grant of License: Upon satisfactory compliance, the MD5 license is issued.

Manufacturing License Documents Required

For the rigid non-bladed video intubation laryngoscope, the following documentation is essential:

• Company Constitution, Memorandum & Articles of Association
• Proof of ownership or lease agreement for manufacturing premises
• Details and qualifications of technical personnel
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) covering facility layout and quality management (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File highlighting hazard analysis and mitigation (Risk Management)
• Test Reports from government-approved labs
• Product labels, packaging, and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15)

For importers of this device into India, the MD15 license is required. The process is handled by the Central Licensing Authority and takes approximately 5 to 6 months.

Key steps for import licensing include:

• Preparation of mandatory documents including existing manufacturing license, Free Sale Certificate, CE Certificate, etc.
• Submission of application on the CDSCO MD Online Portal
• Resolution of any queries raised by CDSCO
• Issuance of Import License (Form MD15)

For detailed guidance, refer to our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for distribution in India
• Company Constitution and incorporation documents

Timeline and Processing Duration

Overall, manufacturers should anticipate a 3 to 4 months timeline for complete MD5 licensing for the rigid non-bladed video intubation laryngoscope.

Government Fees and Costs

• Test License (MD13): No separate government fee but cost incurred in product testing
• MD5 License Fees: Rs. 5,000 per application + Rs. 500 per product
• Product Testing Costs: Varies by lab and tests required; typically Rs. 50,000 to Rs. 1,00,000
• Notified Body Audit Fees: Typically between Rs. 30,000 to Rs. 70,000 depending on the notified body

Proper budgeting for these costs upfront can prevent delays and unexpected expenses.

Common Challenges and Solutions

• Delays in Product Testing: Engage early with approved labs and schedule tests promptly to avoid bottlenecks.
• Incomplete Documentation: Utilize checklists and expert reviews; our Device Master File Guide helps ensure completeness.
• Audit Readiness: Coordinate closely with notified bodies from the Notified Bodies List and conduct internal pre-audits.
• Regulatory Updates: Stay informed about CDSCO notifications; for instance, the device falls under notification 29/Misc/03/2020-DC(177) dated 12.07.2021.

Expert Consultation and Support

Navigating CDSCO regulations can be complex. With our extensive experience assisting over 500 companies, we provide tailored solutions including:

• Regulatory strategy planning
• Document preparation and review
• Liaison with CDSCO authorities and notified bodies
• Training on compliance and audit readiness

We leverage the CDSCO MD Online Portal and other official resources to streamline your application process.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device risk class and applicable licensing route.
2. Prepare Initial Documentation: Begin compiling your Device Master File, Plant Master File, QMS documents, and risk files.
3. Apply for Test License (MD13): Submit your test license application through the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with government-approved labs early; avoid last-minute rush.
5. Engage a Notified Body: Select from the CDSCO Notified Bodies List to plan your audit.
6. Submit MD5 License Application: Use Form MD3 on the online portal once test results are in.
7. Prepare for Audit and Queries: Ensure your team is ready to provide clarifications and additional data promptly.

Proactive planning and expert guidance can significantly reduce approval timelines and ensure smooth market entry of your rigid non-bladed video intubation laryngoscope.

For personalized assistance, detailed checklists, and updates, reach out to our regulatory experts who specialize in CDSCO medical device licensing.