CDSCO License for Antimicrobial endotracheal tube, paediatric

Comprehensive Guide to CDSCO Licensing for Pediatric Antimicrobial Endotracheal Tubes (Class C)

Manufacturers and importers seeking to market antimicrobial endotracheal tubes for pediatric use in India need a thorough understanding of the CDSCO regulatory framework. These devices, categorized under pediatric and neonatology applications, are classified as Class C medical devices due to their critical role in airway management and infection prevention. With over 25 years’ experience assisting 500+ companies, we provide you with practical insights, timelines, costs, and document requirements specific to securing your CDSCO license efficiently.

CDSCO Regulatory Framework for Antimicrobial Endotracheal Tubes

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules (MDR) 2017. An antimicrobial endotracheal tube— a sterile, single-use device used to maintain airway patency and coated with agents such as silver to reduce infection risk— falls under the Class C category due to its direct impact on patient safety in critical care.

Since this device is intended for pediatric patients, regulatory scrutiny is even more stringent, requiring manufacturers/importers to fulfill all technical, quality, and safety compliance aspects.

Risk Classification and License Requirements

According to the CDSCO classification, the antimicrobial endotracheal tube is a Class C device. This means:

• The license must be obtained from the Central Licensing Authority.
• The manufacturing license is issued as an MD9 license (Application Form MD7).
• For importers, an MD15 import license is mandatory.

Class C devices require comprehensive documentation, product testing by government-approved labs, and a thorough audit by CDSCO inspectors before license issuance.

Manufacturing License Process for Class C Devices (MD9)

Obtaining an MD9 manufacturing license involves a multi-step process:

1. Test License (Form MD13): Initially, you must apply for a test license which permits limited manufacture for testing purposes. This process takes approximately 1.5 to 2 months.

2. Product Testing: After the test license, the device must be tested in government-recognized laboratories to verify compliance with standards. You can refer to the list of testing laboratories approved by CDSCO.

3. Documentation Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documentation.

4. Application Submission: File your manufacturing license application online on the CDSCO MD Online Portal using Form MD7.

5. Audit by CDSCO Inspectors: Following application, an on-site audit is conducted to verify compliance with manufacturing practices, QMS, and documentation.

6. Query Resolution: Address any queries raised by the CDSCO during the review and audit process promptly.

7. Grant of License: Upon successful review and audit, the MD9 license is granted.

For detailed guidance, our MD9 License Guide offers step-by-step assistance.

Manufacturing License Documents Required

For the pediatric antimicrobial endotracheal tube, you will need the following documents:

• Company Constitution: Certificate of incorporation, partnership deed, or other legal documents.
• Proof of Ownership or Lease of Manufacturing Premises: Valid property documents.
• Technical Staff Details: Qualification and experience certificates of key personnel.
• Fire NOC and Pollution NOC: Compliance certificates from local authorities.
• Device Master File (DMF): Detailed design, manufacturing process, and validation data. Learn more from our Device Master File guide.
• Plant Master File (PMF): Information on manufacturing facilities and equipment. Refer to our Plant Master File guide.
• Essential Principles Checklist: Declaration of compliance with Indian Medical Device Rules.
• Risk Management File: Demonstrating implementation of risk mitigation strategies as per ISO 14971. Our Risk Management guide can help.
• Test Reports: Results from government-approved laboratories.
• Labels and Instructions for Use (IFU): Device labeling and usage instructions complying with CDSCO requirements.
• Quality Management System Documents: ISO 13485 certification and related QMS manuals.

Import License Process (MD15) for Class C Devices

If you are importing the antimicrobial endotracheal tube, an MD15 license is mandatory. The process includes:

1. Document Compilation: Collect required export and technical documents.

2. Application Submission: Apply online via the CDSCO MD Online Portal using Form MD14.

3. Queries and Review: CDSCO reviews the application and raises any queries.

4. License Grant: Upon satisfaction, the import license (Form MD15) is issued.

Note that test licenses are not required for imports, but you must submit comprehensive documentation including:

• Manufacturer’s valid MD9 manufacturing license.
• Free Sale Certificate from the country of origin.
• ISO 13485:2016 certificate.
• CE certificate or equivalent international approvals.
• Device Master File and Plant Master File.
• Wholesale license and company constitution.

Our Import License Guide details this process further.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months.
• Product Testing: 1 to 1.5 months (varies by lab workload).
• Manufacturing License (MD9): 4 to 5 months including audit and query resolution.
• Import License (MD15): 5 to 6 months.

Plan your regulatory timeline accordingly, as overlapping activities (like documentation preparation during product testing) can help reduce overall time.

Government Fees and Costs

• MD9 Manufacturing License: Rs. 50,000 per application + Rs. 1,000 per product.
• Test License (MD13): Fees vary by state but are generally included within MD9 application costs.
• MD15 Import License:
  • Class C & D: Approximately $3,000 per site +$1,500 per product.

Additional costs include product testing fees at government-approved labs and expenses related to audit preparation and QMS implementation.

Common Challenges and Solutions

• Delayed Test Reports: To avoid delays, engage labs early and verify their testing capacity for antimicrobial coatings and pediatric device specifications.
• Incomplete Documentation: Use detailed checklists and professional regulatory consultants to ensure all device-specific documents are compliant.
• Audit Non-compliance: Conduct mock audits and internal QMS assessments before official CDSCO inspection.
• Query Management: Respond promptly and comprehensively to CDSCO queries to prevent process stalling.

Expert Consultation and Support

With extensive experience navigating CDSCO medical device regulations, our consultancy offers tailored support including:

• Gap analysis of your current documentation against CDSCO requirements.
• Assistance in preparing Device and Plant Master Files.
• Coordination with notified bodies and government labs.
• End-to-end application management on the CDSCO MD Online Portal.

Our proven track record includes successful approvals for pediatric airway devices analogous to antimicrobial endotracheal tubes, ensuring your product reaches the Indian market without regulatory hurdles.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm your device’s risk class as Class C on the Medical Device Classification portal.

2. Prepare Technical Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File.

3. Apply for Test License (Form MD13): Submit through the CDSCO MD Online Portal to initiate the testing phase.

4. Schedule Product Testing: Coordinate with government-recognized labs early to book testing slots.

5. Develop QMS Systems: Align your quality management processes with ISO 13485 requirements.

6. Engage with Regulatory Consultants: Leverage expert guidance to streamline document submission, audit readiness, and query responses.

By following these actionable steps and leveraging professional support, manufacturers and importers can confidently navigate the regulatory landscape for pediatric antimicrobial endotracheal tubes in India.

For personalized assistance and detailed walkthroughs, contact us to benefit from our 25+ years of CDSCO regulatory expertise.