CDSCO License for Circulating-air whole- body heating/cooling system pad, single- use, sterile

Comprehensive Guide to CDSCO Licensing for Circulating-Air Whole-Body Heating/Cooling System Pads (Sterile, Single-Use)

As seasoned regulatory consultants with over 25 years of experience and having supported more than 500 companies in navigating the CDSCO licensing process, we understand the complexities involved in obtaining the necessary approvals for specialized medical devices. This guide focuses on the Circulating-air whole-body heating/cooling system pad, single-use, sterile, classified as a Class B medical device under the CDSCO framework, primarily used in pediatric and neonatology settings for temperature regulation during surgeries and intensive care.

Understanding the Device and Its Regulatory Significance

This device serves as a sterile underlay or overlay where heated or cooled air circulates to adjust a patient’s core body temperature. Given its critical role in patient care and the fact that it is single-use and sterile, ensuring compliance with CDSCO regulations is paramount for market access in India. The device’s classification as Class B means it is considered low to moderate risk, which influences the licensing pathway, timelines, and requirements.

CDSCO Regulatory Framework for Circulating-Air Whole-Body Heating/Cooling System Pads

The Central Drugs Standard Control Organization (CDSCO) governs the approval and regulation of medical devices in India. Medical devices are categorized into four risk classes: A, B, C, and D, with Class B devices requiring a Manufacturing License MD5 (Form MD3) issued by the State Licensing Authority.

For this device:

• Risk Classification: Class B
• Applicable License: MD5 Manufacturing License
• Regulatory Notification: File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021

Understanding these details is critical for a smooth application process.

Risk Classification and License Requirements

Being a Class B device, the circulating-air whole-body heating/cooling system pad falls under moderate risk. The CDSCO mandates manufacturers to obtain an MD5 license, which involves:

• Obtaining a Test License (MD13) initially
• Product testing at government-approved laboratories
• Submission of comprehensive technical and quality management documentation
• Audit by a notified body

You can verify Class B classification and related device details on the Medical Device Classification guide.

Manufacturing License Process (MD5)

The MD5 license process is administered by the State Licensing Authority and typically takes 3 to 4 months from start to finish. Here’s a stepwise breakdown:

1. Application for Test License (Form MD13): Required before starting manufacturing and testing, this takes approximately 1.5 to 2 months.
2. Product Testing: Conducted at CDSCO-approved testing laboratories; testing duration depends on the device complexity.
3. Documentation Preparation: Including Device Master File, Plant Master File, Risk Management File, and Quality Management System documents.
4. Submission of Manufacturing License Application (Form MD3): Completed on the CDSCO MD Online Portal.
5. Audit by Notified Body: The notified body conducts an on-site audit of manufacturing facilities and QMS.
6. Resolution of Queries: Address any deficiencies or queries raised by authorities or notified bodies.
7. Grant of MD5 License (Form MD5): Upon satisfactory review and audit.

For detailed guidance, consult our in-depth MD5 License Guide.

Manufacturing License Documents Required

Preparing the right documentation is crucial. For the circulating-air whole-body heating/cooling system pad, you will need:

• Company Constitution Documents: Certificate of Incorporation, Memorandum & Articles of Association
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification Details: Engineers, quality managers, and other key personnel
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed device specifications, manufacturing process, and design controls (Device Master File Guide)
• Plant Master File (PMF): Facility layout, equipment details, and process controls (Plant Master File Guide)
• Essential Principles Checklist: Compliance with Indian Medical Device Rules
• Risk Management File: Hazard analysis and mitigation strategies (Risk Management)
• Test Reports: From government-approved labs (Testing Laboratories)
• Labels and Instructions for Use (IFU): Clear, compliant labeling and usage instructions
• Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs

Ensuring completeness and accuracy in documentation reduces the likelihood of delays.

Import License Process (MD15)

If you are an importer of this device into India rather than a manufacturer, you must apply for an MD15 Import License through the Central Licensing Authority. The process typically takes 5 to 6 months and does not require a test license.

Steps include:

• Document preparation (including Manufacturing License from the country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016)
• Application submission on the CDSCO MD Online Portal
• Resolution of queries
• License grant

For further details, our Import License Guide is a valuable resource.

Import License Documents Required

Importers must submit:

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution documents

Fee structure depends on device class; for Class B devices, fees are moderate compared to higher-risk classes.

Timeline and Processing Duration

Proactive communication with CDSCO and prompt response to queries can help expedite the process.

Government Fees and Costs

For a Class B device like the circulating-air heating/cooling pad, expect the following fees:

• MD5 License: Rs 5000 per application + Rs 500 per product
• MD13 Test License: Included within the MD5 timeline and fees

Additional costs include:

• Notified body audit fees (variable depending on the auditor)
• Testing laboratory charges
• Consultancy fees (if engaging experts)

Budgeting for these expenses upfront helps avoid surprises.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all technical files, licenses, and certificates are current and complete.
• Delayed Product Testing: Schedule testing early and confirm lab availability.
• Audit Non-Compliance: Conduct internal mock audits ahead of CDSCO or notified body inspections.
• Query Resolution Delays: Assign a dedicated regulatory liaison to address queries promptly.

Our experience shows that manufacturers who prepare thoroughly and maintain transparent communication with authorities experience smoother approvals.

Expert Consultation and Support

Engaging with regulatory experts who understand the nuances of the CDSCO process for Class B medical devices can significantly reduce approval time and compliance risks. We offer end-to-end support—from dossier preparation and submission through audit coordination and post-approval compliance.

Getting Started with Your CDSCO License Application

1. Assess your device classification to confirm the need for an MD5 license.
2. Register on the CDSCO MD Online Portal.
3. Gather and prepare all required documents as outlined above.
4. Apply for the Test License (MD13) to initiate product testing.
5. Coordinate with notified bodies early to schedule your audit.
6. Maintain open communication channels with CDSCO to promptly address queries.

By following this structured approach, manufacturers of the circulating-air whole-body heating/cooling system pad can confidently navigate the CDSCO licensing process and accelerate their entry into the Indian market.

For personalized assistance, reach out to our expert regulatory team to discuss your specific device and licensing strategy.