CDSCO License for Endobronchial airway sizing kit

Introduction to Endobronchial Airway Sizing Kit and Regulatory Importance

The Endobronchial airway sizing kit is a specialized mechanical medical device intended for anesthesiology applications. It is designed to assist clinicians in determining the correct sizes of endobronchial valves during planned lung interventions using balloon catheters. Given its direct application in airway management, ensuring regulatory compliance is paramount to guarantee safety and efficacy.

In India, all medical devices, including the Endobronchial airway sizing kit, must comply with the Central Drugs Standard Control Organization (CDSCO) regulations to legally manufacture or import and market them. Our extensive experience, having assisted over 500 companies, underscores the importance of navigating the CDSCO licensing process accurately to avoid delays and ensure smooth market entry.

CDSCO Regulatory Framework for Endobronchial Airway Sizing Kits

The CDSCO regulates medical devices based on risk classification under the Medical Device Rules, 2017. The Endobronchial airway sizing kit is categorized under Class A (low risk), as per Notification 29/Misc/03/2020-DC(177) dated 12.07.2021. This classification places it under the purview of the State Licensing Authority for manufacturing licenses.

Manufacturing and import licensing for such devices require adherence to prescribed procedures, documentation, and quality standards aligned with Indian regulations and international best practices.

Risk Classification and License Requirements for Class A Devices

Class A devices represent the lowest risk category under CDSCO guidelines. Devices like the Endobronchial airway sizing kit fall here due to their mechanical nature and limited invasiveness.

For Class A devices, the manufacturing license is issued via the MD5 license (application Form MD3) by the State Licensing Authority. Import licenses fall under MD15 but are centrally administered and less common for this device category.

Key points for Class A licensing:

• License Type: MD5 for manufacturing
• Regulatory Authority: State Licensing Authority
• Timeline: Approximately 3-4 months including test license and audit
• Fees: Rs 5,000 application fee + Rs 500 per product

Step-by-Step Manufacturing License Process (MD5) for Endobronchial Airway Sizing Kit

1. Obtain Test License (Form MD13): Before applying for the MD5 license, the manufacturer must obtain a test license for the device. This permits prototype testing and regulatory evaluation. The test license process typically takes 1.5 to 2 months.

2. Product Testing: Conduct product testing at CDSCO-approved government laboratories to verify compliance with applicable standards.

3. Document Preparation: Compile all essential documents, including Device Master File, Plant Master File, risk management documents, and quality system evidence.

4. Application Submission: Apply for the MD5 license on Form MD3 via the CDSCO MD Online Portal.

5. Audit by Notified Body: Schedule and undergo a factory audit by a notified body listed on the CDSCO Notified Bodies List. The audit verifies compliance of manufacturing processes with regulatory standards.

6. Resolution of Queries: Address any queries or deficiencies raised by CDSCO officials or the notified body promptly.

7. Grant of MD5 License: Upon satisfactory review, the license is granted in Form MD5, authorizing manufacturing.

For a detailed walkthrough, our MD5 License Guide elaborates on these steps.

Essential Documents Required for MD5 License Application

Manufacturers must submit comprehensive documentation, including but not limited to:

• Company Constitution/Registration Certificate
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Qualification and Experience Proofs
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, manufacturing, and performance data (See our DMF Guide)
• Plant Master File (PMF) describing manufacturing facilities and processes (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with Indian regulations
• Risk Management File outlining hazard identification and mitigation (Risk Management Resource)
• Test Reports from CDSCO-approved labs (Testing Laboratories List)
• Labeling and Instructions For Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Ensuring these documents are comprehensive and accurate significantly reduces review time.

Import License Process for Endobronchial Airway Sizing Kit (MD15)

While primarily applicable to manufacturers, importers of the Endobronchial airway sizing kit must apply for an import license under Form MD14, resulting in an MD15 license.

Key features:

• Issued by the Central Licensing Authority
• Processing time approximately 5-6 months
• No test license required
• Requires submission of manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, Device Master File, Plant Master File, wholesale license, and company constitution.

Fees vary by device class but for Class A devices, the fee is approximately $1000 per site plus$50 per product.

For import licensing assistance, refer to our Import License Guide.

Timeline and Processing Duration

Planning for these timelines and initiating early testing and documentation can expedite approvals.

Government Fees and Costs

For manufacturing the Endobronchial airway sizing kit (Class A):

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs may include:

• Testing fees charged by government-approved labs
• Notified body audit charges
• Consultancy fees if engaging regulatory experts

Budgeting for these fees upfront will prevent surprises.

Common Challenges and Practical Solutions

• Incomplete Documentation: Missing or inconsistent files are a frequent cause of delays. Solution: Use detailed checklists and professional review before submission.

• Audit Non-Compliance: Audit failures due to facility or process gaps. Solution: Conduct pre-audit internal assessments and remediate issues.

• Testing Delays: Backlogs at testing labs can stall progress. Solution: Schedule tests early and consider alternate approved labs.

• Query Resolution Prolonged: Slow responses to CDSCO queries extend timelines. Solution: Maintain a dedicated team for immediate query handling.

Our hands-on experience helps clients anticipate and navigate these hurdles efficiently.

Expert Consultation and Support

With over 25 years in medical device regulatory consulting, we offer tailored support for the Endobronchial airway sizing kit CDSCO licensing process. From documentation preparation to audit readiness and submission follow-up, our experts ensure compliance and timely approvals.

Our clients benefit from:

• Deep understanding of CDSCO regulatory nuances
• Access to a network of accredited testing laboratories and notified bodies
• Proven strategies to minimize rejection risks

Engage with us early to leverage our expertise and accelerate your market entry.

Getting Started with Your CDSCO License Application for Endobronchial Airway Sizing Kit

1. Assess Your Device Classification: Verify that the Endobronchial airway sizing kit is Class A as per the latest CDSCO notifications.

2. Prepare Essential Documents: Begin compiling corporate, technical, and quality documents using our guides on Device Master Files and Plant Master Files.

3. Apply for Test License (MD13): Submit Form MD13 via the CDSCO MD Online Portal. Early application helps avoid delays.

4. Schedule Product Testing: Coordinate with CDSCO approved labs to initiate testing promptly.

5. Plan for Audit: Identify and liaise with a notified body from the official Notified Bodies List and prepare your facility accordingly.

6. Submit MD5 License Application (Form MD3): Upon readiness, submit your manufacturing license application online.

7. Respond to Queries: Assign dedicated resources to handle any CDSCO or notified body queries swiftly.

By following these practical steps, manufacturers can streamline their CDSCO MD5 licensing journey and bring the Endobronchial airway sizing kit to the Indian market efficiently and compliantly.