CDSCO License for Infant resuscitation cabinet

Comprehensive Guide to CDSCO Licensing for Infant Resuscitation Cabinets (Class B Medical Device)

Infant resuscitation cabinets play a critical role in pediatric and neonatology care, providing a controlled environment for the emergency resuscitation of newborns who struggle to breathe spontaneously at birth. Given their vital function and complexity, these devices fall under Class B medical devices in India, requiring stringent regulatory oversight by the Central Drugs Standard Control Organization (CDSCO).

With over 25 years of experience assisting more than 500 medical device companies, we understand the nuances and practical challenges manufacturers and importers face in obtaining CDSCO licenses. This detailed guide breaks down the regulatory framework, licensing pathways, cost structures, and timelines specifically tailored for infant resuscitation cabinets.

CDSCO Regulatory Framework for Infant Resuscitation Cabinets

The infant resuscitation cabinet is governed by the Medical Device Rules (MDR) 2017 and subsequent amendments notified by CDSCO. Classified as a Class B device, it requires registration and manufacturing license approval from the State Licensing Authority via the MD5 license process.

The notification under File No. 29/MiscJ03/2020-DC (150) dated 23.8.2021 confirms the device classification and regulatory requirements. Compliance with the Essential Principles of Safety and Performance and adherence to ISO 13485 quality management standards are mandatory.

Manufacturers must also ensure conformity with risk management practices as per ISO 14971, given the device’s critical clinical application.

Risk Classification and License Requirements for Infant Resuscitation Cabinets

• Risk Class: B (Low-moderate risk)
• Required License: MD5 Manufacturing License (Form MD3 application)
• Licensing Authority: State Licensing Authority
• Approval Timeline: Approximately 3-4 months (including test license and audit)

Since this is a Class B device, the MD5 license route is applicable. This involves obtaining a test license first (Form MD13), conducting product testing in CDSCO-approved laboratories, followed by audit by an accredited notified body.

For detailed classification references, visit our Medical Device Classification guide.

Manufacturing License Process (MD5) for Infant Resuscitation Cabinets

The MD5 licensing process is methodical and includes multiple stages:

1. Test License Application (Form MD13): Apply on the CDSCO MD Online Portal to obtain permission for sample testing. This phase takes around 1.5 to 2 months.

2. Product Testing: Submit device samples to CDSCO-recognized testing laboratories (list available here) to verify safety and performance parameters.

3. Document Preparation & Submission: Prepare comprehensive technical documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, and other required documents.

4. Audit by Notified Body: Coordinate with a CDSCO-approved notified body (notified bodies list) for a manufacturing site audit.

5. Query Resolution: Address any queries raised by the authority or notified body promptly.

6. Grant of License: Upon successful audit and documentation review, the State Licensing Authority issues the MD5 license (Form MD5).

For an in-depth overview, refer to our MD5 License Guide.

Manufacturing License Documents Required for Infant Resuscitation Cabinets

The documentation package must be thorough and precise to avoid delays:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (Technical Specifications, Design, and Manufacturing Process) — see our Device Master File guide
• Plant Master File (Quality Management, Infrastructure) — detailed in our Plant Master File guide
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File aligned with ISO 14971 standards (Risk Management guidance)
• Valid Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation

Attention to detail in these documents significantly smooths the approval process.

Import License Process (MD15) for Infant Resuscitation Cabinets

While this guide primarily addresses manufacturers, importers of infant resuscitation cabinets must obtain the MD15 import license granted by the Central Licensing Authority.

The process includes:

1. Document compilation including existing manufacturing licenses, Free Sale Certificates, ISO 13485 certification, CE certificates if applicable, DMF, PMF, and wholesale licenses.
2. Submission of Form MD14 application on the CDSCO MD Online Portal.
3. Resolution of departmental queries.
4. Grant of MD15 import license.

The entire import licensing process generally spans 5-6 months.

For comprehensive 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 or equivalent
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution

Timeline and Processing Duration

This timeline presumes prompt responses and complete documentation. Delays often occur due to incomplete submissions or inadequate test reports.

Government Fees and Costs

• MD5 License Application Fee: ₹5,000 per application
• Per Product Fee: ₹500

Additional costs include:

• Testing fees charged by third-party government-approved laboratories
• Fees for audits conducted by notified bodies
• Costs related to document preparation, consultant fees, and technical staffing

Budgeting realistically for these expenses upfront prevents surprises.

Common Challenges and Solutions

1. Incomplete Documentation: One of the most frequent causes of delay is incomplete or inconsistent technical files. We recommend using detailed checklists and templates to ensure all documents meet CDSCO standards.

2. Testing Delays: Testing laboratories may have backlogs. To mitigate this, book testing slots early and ensure samples meet test criteria to avoid retesting.

3. Audit Non-conformities: Prepare your manufacturing site meticulously to comply with Good Manufacturing Practices (GMP) and Quality Management Systems. Pre-audit mock inspections can identify gaps.

4. Regulatory Changes: Stay updated on CDSCO notifications, as device classification and requirements may evolve. Subscribe to official CDSCO updates and regulatory newsletters.

Expert Consultation and Support

Navigating CDSCO licensing for infant resuscitation cabinets requires expertise in regulatory affairs, quality systems, and clinical device standards. Our consultancy has supported over 500 companies in successfully obtaining MD5 licenses through:

• Personalized gap analysis and readiness assessments
• Comprehensive document drafting and review
• Coordination with notified bodies and testing labs
• Timely query management and follow-up

Partnering with experienced consultants can significantly reduce the approval timeline and prevent costly rejections.

Getting Started with Your CDSCO License Application

To kickstart your CDSCO licensing journey for infant resuscitation cabinets, follow these practical steps:

1. Classification Confirmation: Verify your device classification through official CDSCO notifications and our classification guide.

2. Prepare Technical Documentation: Begin compiling your Device and Plant Master Files, risk management files, and QMS documents.

3. Apply for Test License: Submit Form MD13 on the CDSCO MD Online Portal to obtain permission for product testing.

4. Engage Testing Laboratories: Coordinate with CDSCO-approved labs early to schedule sample testing.

5. Schedule Audit: Identify a notified body from the official list and plan the audit.

6. Submit Manufacturing License Application: Once test reports and audit reports are ready, apply using Form MD3 for the MD5 license.

7. Respond to Queries Promptly: Maintain open communication with CDSCO and notified bodies to resolve any queries swiftly.

By approaching each step methodically and leveraging expert support, manufacturers and importers can ensure timely market entry while maintaining compliance and patient safety.

For further assistance, reach out to our experienced regulatory team dedicated to facilitating your CDSCO licensing needs.