CDSCO License for Retrograde endotracheal intubation kit

Understanding Retrograde Endotracheal Intubation Kit and Its Regulatory Importance

The Retrograde Endotracheal Intubation Kit is a vital anesthesiology device designed to aid clinicians in placing an endotracheal tube in challenging airway scenarios. Its role during difficult or emergency airway access procedures underscores the critical nature of safety, quality, and regulatory compliance. For manufacturers and importers aiming to enter the Indian medical device market, securing the appropriate CDSCO license is mandatory to ensure lawful marketing and distribution.

As regulatory consultants with over 25 years of experience and having assisted more than 500 companies, we understand the nuances involved in obtaining CDSCO approval for such devices. This comprehensive guide lays out the entire licensing pathway specifically for this Class B device, helping you navigate the process efficiently.

CDSCO Regulatory Framework for Retrograde Endotracheal Intubation Kit

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. Since the Retrograde Endotracheal Intubation Kit is classified under anesthesiology and categorized as a Class B device (low moderate risk), it falls under the purview of State Licensing Authorities for manufacturing licenses.

The CDSCO notification number 29/Misc/03/2020-DC(177), dated 12.07.2021, specifically includes this device under regulated categories, mandating compliance with licensing and quality standards before market entry.

Risk Classification and License Requirements for Class B Devices

India classifies medical devices into four risk classes: A, B, C, and D. The Retrograde Endotracheal Intubation Kit falls under Class B due to its moderate risk profile. This classification requires a manufacturing license under Form MD5, issued by the State Licensing Authority.

The application process involves obtaining a test license first (Form MD13), conducting product testing in government-approved labs, and undergoing a notified body audit before final license approval.

Manufacturing License Process for Retrograde Endotracheal Intubation Kit (MD5 License)

The manufacturing license process for Class B devices generally spans 3 to 4 months. Here is a stepwise breakdown:

1. Apply for Test License (Form MD13): This preliminary license allows you to manufacture the device for testing purposes. The timeline is approximately 1.5 to 2 months.

2. Product Testing: Conduct mandatory product testing through government-approved testing laboratories. The list of approved labs can be referenced on the CDSCO Testing Laboratories portal.

3. Document Preparation: Compile all required documents including Device Master File, Plant Master File, and risk management documentation.

4. Apply for Manufacturing License (Form MD3 for MD5 license): Submit the application on the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit is conducted by a notified body (see the list of notified bodies) to verify compliance with Good Manufacturing Practices (GMP).

6. Resolution of Queries: Address any queries raised by the regulatory authority or the notified body promptly.

7. Grant of License: Upon successful review, the State Licensing Authority issues the manufacturing license on Form MD5.

Manufacturing License Documents Required for Retrograde Endotracheal Intubation Kit

To ensure a smooth application process, prepare the following documents meticulously:

• Company Constitution: Incorporation certificate, partnership deed, or other legal documents.
• Proof of Ownership/Lease of Manufacturing Premises: Valid ownership or lease agreement.
• Technical Staff Details: Qualifications and experience of technical personnel involved in manufacturing.
• Fire and Pollution NOCs: Fire safety and environmental clearance certificates.
• Device Master File (DMF): Detailed technical specifications and design, as outlined in our in-depth Device Master File guide.
• Plant Master File (PMF): Manufacturing process details and facility layout, guided by our Plant Master File guide.
• Essential Principles Checklist: Compliance checklist demonstrating adherence to MDR 2017.
• Risk Management File: Documentation of risk analysis and mitigation strategies, referencing best practices from our Risk Management resource.
• Test Reports: Certificates from government-approved labs validating product safety and performance.
• Labels and Instructions for Use (IFU): Samples showing compliance with labeling regulations.
• Quality Management System (QMS) Documents: Evidence of implemented QMS, preferably ISO 13485:2016 certification.

Import License Process for Retrograde Endotracheal Intubation Kit (MD15 License)

For importers, obtaining an MD15 license from the Central Licensing Authority is mandatory. The process typically takes 5 to 6 months and does not require a test license.

Steps include:

1. Compile Documents: Including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device Master and Plant Master files.

2. Submit Application: Use Form MD14 on the CDSCO MD Online Portal.

3. Respond to Queries: Timely address any clarifications requested by CDSCO.

4. License Grant: MD15 import license is issued upon satisfaction of all regulatory requirements.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate confirming the device is approved and sold in the country of origin
• ISO 13485:2016 Certification demonstrating quality management
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License for distribution
• Company Constitution documents

Timeline and Processing Duration

Planning your project timeline with these benchmarks helps avoid costly delays.

Government Fees and Costs

For the Retrograde Endotracheal Intubation Kit (Class B):

• MD5 License Fees: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Included in overall process

Import license fees (MD15) vary by class and product count; for Class B devices, fees are higher and must be checked on the CDSCO portal.

Budgeting for these fees upfront ensures smoother cash flow management.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with audit requirements.

Solution: Engage experienced consultants early, conduct internal audits, and ensure comprehensive preparation of DMF, PMF, and risk files.

Challenge: Difficulty in product testing due to limited approved labs.

Solution: Plan and schedule testing well in advance using the CDSCO-approved testing laboratories.

Challenge: Queries raised by authorities causing process bottlenecks.

Solution: Respond promptly and precisely with supporting documentation.

Expert Consultation and Support

With over 25 years of assisting 500+ companies, our expert team offers tailored regulatory consulting, document preparation, and liaison services to simplify your CDSCO license journey. From audit readiness to risk management implementation, we provide end-to-end support.

Getting Started with Your CDSCO License Application

Ready to launch your Retrograde Endotracheal Intubation Kit in India? Begin by:

1. Registering on the CDSCO MD Online Portal.
2. Compiling the required documentation meticulously.
3. Applying for the Test License (Form MD13) if manufacturing locally.
4. Scheduling product testing at approved labs early in the process.
5. Preparing for the notified body audit by reviewing GMP compliance.

Engage with experienced regulatory consultants to navigate complexities, avoid pitfalls, and accelerate approval timelines. Contact us today to discuss your project and leverage our deep expertise in Indian medical device regulations.