CDSCO License for Warming high-flow infusion pump

Comprehensive Guide to CDSCO Licensing for Warming High-Flow Infusion Pumps (Class C Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for high-risk devices like the warming high-flow infusion pump. This device, designed to heat and rapidly infuse blood or other fluids during critical surgical procedures involving major bleeding or burns, falls under Class C risk category, requiring a stringent approval process by the Central Drugs Standard Control Organization (CDSCO).

With over 25 years of expertise and having assisted 500+ manufacturers and importers, we provide an in-depth, step-by-step guide to securing your CDSCO license efficiently and compliantly.

CDSCO Regulatory Framework for Warming High-Flow Infusion Pumps

The CDSCO governs medical device regulation in India under the Medical Device Rules (MDR) 2017. Devices like the warming high-flow infusion pump are categorized based on risk, intended use, and complexity. As an operation theatre device with a direct impact on patient safety, this infusion pump is classified as Class C, necessitating a robust regulatory process.

The official notification for this device is File No. 29/Misc/03/2020-DC (199), dated 13.09.2021, which clarifies its inclusion in the CDSCO regulated list.

Risk Classification and License Requirements

According to the Medical Device Classification guidelines, Class C devices are medium to high risk, which means manufacturers must obtain an MD9 manufacturing license issued by the CDSCO Central Licensing Authority.

For importers, the MD15 import license is mandatory. The MD9 license process is more rigorous than Class A/B due to the device’s critical use in life-supporting therapy.

Manufacturing License Process (MD9)

The MD9 license involves multiple stages:

1. Test License (Form MD13) – Initiate by applying for a test license, valid for 3-6 months, allowing prototype production for testing. This phase typically takes 1.5-2 months.

2. Product Testing – Conducted in CDSCO-approved labs listed here. Testing ensures compliance with Indian standards and safety.

3. Document Preparation – Assemble comprehensive documentation including Device Master File, Plant Master File, Risk Management File, QMS documents, and others.

4. Application Submission (Form MD7) – Submit the manufacturing license application via the CDSCO MD Online Portal. Ensure all documents are complete to avoid delays.

5. Audit by CDSCO Inspectors – The CDSCO conducts an on-site audit verifying compliance with MDR 2017 and Good Manufacturing Practices (GMP).

6. Query Resolution – Address any clarifications or deficiencies raised during audit or document review.

7. Grant of License (Form MD9) – Upon satisfactory review, CDSCO issues the manufacturing license.

For detailed guidance, refer to our MD9 License Guide.

Manufacturing License Documents Required

Your MD9 license application should include the following key documents:

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Technical staff qualifications and experience
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing the manufacturing site (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian regulatory requirements
• Risk Management File demonstrating hazard identification and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU) complying with regulations
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Ensuring accuracy and completeness of these documents can significantly shorten the review time.

Import License Process (MD15)

If you intend to import warming high-flow infusion pumps into India, the MD15 import license is mandatory and issued by the CDSCO Central Licensing Authority.

The steps are:

1. Document Preparation – Collect required documents including manufacturing license, Free Sale Certificate, ISO and CE certificates, DMF, PMF, and wholesale license.

2. Application Submission (Form MD14) – File your application through the CDSCO MD Online Portal.

3. Query Resolution – Respond promptly to any queries raised by CDSCO.

4. Grant of Import License (Form MD15) – Post successful review, CDSCO grants the import license allowing legal import and marketing.

For more details, our Import License Guide offers practical insights.

Import License Documents Required

Key documents for MD15 include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate (FSC) or Certificate of Marketing Authorization
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License for distribution
• Company Constitution and legal documents

Timeline and Processing Duration

Manufacturers should plan for a total of approximately 4 to 5 months for the MD9 license process, factoring in testing and audits.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application fee: Rs. 50,000 per application
  • Product fee: Rs. 1,000 per product

• MD13 Test License: Included in the MD9 timeline; nominal fees apply.

• MD15 Import License: Fees vary by device class, with Class C devices attracting around $3,000 per site and$1,500 per product.

Budgeting accurately helps avoid surprises and supports timely submission.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or inconsistent documents. We recommend systematic cross-checking against CDSCO checklists.

• Delayed Product Testing: Testing in approved labs can take longer if samples are not properly prepared. Early engagement with labs listed here is advised.

• Audit Non-Compliance: Ensure your manufacturing facility complies with GMP and MDR 2017 before audit visits to reduce rejections.

• Query Management: Respond to CDSCO queries promptly and thoroughly to avoid prolonged processing times.

Expert Consultation and Support

With decades of hands-on experience, we offer tailored consultancy to navigate the complexities of CDSCO licensing for Class C devices like the warming high-flow infusion pump. From document preparation to audit readiness and timely submission, our expert team ensures a smooth approval journey.

Getting Started with Your CDSCO License Application

1. Assess your device’s classification and regulatory requirements thoroughly.
2. Prepare your Device Master File and Plant Master File with adherence to Indian standards.
3. Apply for the Test License (MD13) via the CDSCO MD Online Portal to begin prototype testing.
4. Engage with notified testing laboratories early to schedule product testing.
5. Compile full documentation including risk management and quality systems.
6. Submit your MD9 manufacturing license application (Form MD7) on the portal.
7. Prepare for the CDSCO audit by ensuring compliance with all manufacturing and quality requirements.
8. Respond quickly to any queries from CDSCO or auditors.

Starting early and following these steps can significantly expedite the licensing process.

For personalized assistance and to ensure your warming high-flow infusion pump meets all regulatory requirements, contact us today. Our proven expertise in CDSCO licensing will help you bring your critical medical device to the Indian market efficiently and compliantly.