CDSCO License for Infant/regional-body warmer

Comprehensive CDSCO Licensing Guide for Infant/Regional Body Warmers (Class C Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized equipment like the Infant/Regional Body Warmer. This device, designed to provide infrared-controlled heat to newborns and burn patients, falls under risk Class C according to CDSCO regulations due to its critical role in neonatal and adult care. With over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we provide you with a detailed, practical roadmap to acquiring the necessary MD9 manufacturing or import license for this device.

CDSCO Regulatory Framework for Infant/Regional Body Warmers

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Infant/Regional Body Warmers are regulated as Class C devices under the Medical Device Rules (MDR) 2017, which means they must comply with stringent safety and quality norms before entering the Indian market.

Given the device’s specialized application in pediatrics and neonatology, the regulatory framework includes thorough product testing, documentation, and audits by CDSCO authorities to ensure patient safety.

Risk Classification and License Requirements for Infant/Regional Body Warmers

According to the CDSCO classification:

• Device Name: Infant/Regional Body Warmer
• Risk Class: C (Moderate to High Risk)
• Intended Use: Infrared heating device providing regulated thermal environments
• Category: Pediatrics and Neonatology

Class C devices require a Central Licensing Authority (CLA) issued license called MD9, which involves rigorous testing, documentation, and audits.

For a detailed understanding of device classification, visit our Medical Device Classification guide.

Manufacturing License Process (MD9) for Infant/Regional Body Warmers

Step 1: Obtain Test License (MD13)

Before applying for the MD9 license, manufacturers must secure a test license on Form MD13. This license permits the device to be tested by CDSCO-approved laboratories.

• Timeline: Approximately 1.5 to 2 months
• Purpose: Allows product testing under regulatory supervision.

Step 2: Product Testing at Government-Approved Labs

Testing is mandatory to validate safety and performance criteria as per Indian standards.

• Refer to the list of CDSCO-approved testing laboratories for suitable facilities.
• Testing typically includes electrical safety, temperature uniformity, and infrared emission compliance.

Step 3: Documentation Preparation

Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

Step 4: Application Submission for MD9 License (Form MD7)

Submit the application through the CDSCO MD Online Portal, attaching all required documents.

Step 5: CDSCO Inspection and Audit

CDSCO officials will conduct an on-site inspection of your manufacturing or testing facility to verify compliance.

Step 6: Queries and Resolution

Respond promptly to any queries raised by the authorities or audit team to avoid delays.

Step 7: Grant of Manufacturing License (Form MD9)

Upon satisfactory audit and document verification, CDSCO issues the manufacturing license.

For a deeper dive, check our detailed MD9 License Guide.

Manufacturing License Documents Required for Infant/Regional Body Warmers

The documentation set is extensive and critical for approval:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire Safety NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device specifications, design, and manufacturing details (see guide)
• Plant Master File (PMF): Manufacturing process, equipment, and quality control systems (see guide)
• Essential Principles Checklist confirming compliance with MDR 2017
• Risk Management File in line with ISO 14971 (learn more)
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU) complying with Indian regulations
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Import License Process (MD15) for Infant/Regional Body Warmers

For importers, the process is centrally regulated by CDSCO.

Step 1: Document Compilation

Gather necessary documents such as manufacturing license (MD9), Free Sale Certificate from the country of origin, CE Certificate, ISO 13485:2016 certificate, and device technical files.

Step 2: Application Submission

Submit the application on the CDSCO MD Online Portal using Form MD14.

Step 3: Review and Queries

CDSCO reviews the application and may raise queries.

Step 4: License Grant (Form MD15)

Upon satisfactory review, the import license is issued.

For detailed steps and document requirements, refer to our Import License Guide.

Timeline and Processing Duration for Infant/Regional Body Warmers

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months depending on lab workload
• Document Preparation: Variable; typically 2 to 4 weeks
• MD9 License Grant: 2 to 3 months post application submission

Total estimated duration: 4 to 5 months from start to finish.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application Fee: Rs 50,000
  • Per Product Fee: Rs 1,000

• Test License (MD13): Usually included as part of the process; separate fees may apply depending on testing scope.

• Import License (MD15): Fees vary by class; for Class C devices, typically $3,000 per site and$1,500 per product.

Note: Fees are payable via the CDSCO MD Online Portal during application submission.

Common Challenges and Solutions

• Challenge: Delays due to incomplete or inconsistent documentation.

  • Solution: Engage expert consultants early to ensure document completeness and compliance.

• Challenge: Difficulty in scheduling audits or inspections.

  • Solution: Maintain proactive communication with CDSCO and notified bodies; prepare thoroughly for audits.

• Challenge: Testing laboratory backlogs causing timeline extensions.

  • Solution: Plan testing early and select less busy, CDSCO-approved labs from the official list.

• Challenge: Understanding and implementing risk management requirements.

  • Solution: Follow our practical Risk Management implementation guide.

Expert Consultation and Support

With over two decades of experience assisting medical device manufacturers and importers, we provide end-to-end support—from DMF and PMF preparation to audit readiness and regulatory submissions. Our tailored approach ensures that your Infant/Regional Body Warmer meets all CDSCO requirements efficiently.

Our expert team helps you avoid common pitfalls and accelerates your market entry process.

Getting Started with Your CDSCO License Application for Infant/Regional Body Warmers

1. Assess your device classification: Confirm your product’s Class C status.
2. Prepare your Device Master File and Plant Master File with detailed technical and manufacturing information.
3. Apply for the Test License (MD13) via the CDSCO MD Online Portal.
4. Coordinate product testing at a CDSCO-approved laboratory.
5. Compile all required documents including risk management, QMS certificates, and regulatory checklists.
6. Submit your MD9 license application (Form MD7) online.
7. Prepare for and facilitate the CDSCO audit and respond promptly to any queries.

By following these actionable steps and leveraging expert guidance, you can navigate the CDSCO approval process for Infant/Regional Body Warmers with confidence and efficiency.

For personalized assistance and turnkey regulatory solutions, contact us to streamline your CDSCO licensing journey.