CDSCO License for Infant whole-body immobilizer, single- use

Comprehensive Guide to CDSCO Licensing for Infant Whole-Body Immobilizer (Single-Use, Class A)

As a trusted regulatory consultancy with over 25 years of experience and having successfully supported 500+ manufacturers and importers, we present an in-depth guide on securing the CDSCO license for your Infant Whole-Body Immobilizer. This device, classified as Class A due to its low risk, plays an essential role in pediatric and neonatology care by safely immobilizing infants during therapeutic or diagnostic procedures.

Understanding the Infant Whole-Body Immobilizer and Its Regulatory Importance

The Infant Whole-Body Immobilizer is a single-use, non-sterile device typically fabricated from fabric and/or plastic materials. Its primary intent is to temporarily restrict infant movement, often during phototherapy or diagnostic interventions. Despite its seemingly straightforward design, strict regulatory compliance ensures patient safety and product reliability in the Indian market.

Given the device's classification as Class A, regulatory requirements are streamlined but still rigorous. Compliance with the Central Drugs Standard Control Organization (CDSCO) framework is mandatory before marketing in India.

CDSCO Regulatory Framework for Class A Medical Devices

CDSCO governs medical device registration and licensing under the Medical Device Rules (MDR) 2017. Devices are categorized into Class A, B, C, and D based on risk. The Infant Whole-Body Immobilizer falls under Class A, the lowest risk category, regulated at the state level.

Manufacturers of Class A devices must obtain an MD5 Manufacturing License from the respective State Licensing Authority. This license ensures that manufacturing practices, quality systems, and product safety standards comply with Indian regulations.

Risk Classification and License Requirements for Infant Whole-Body Immobilizer

• Device: Infant Whole-Body Immobilizer (single-use)
• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License (Form MD3 application)
• Licensing Authority: State Licensing Authority
• Regulatory Notification: File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021

This classification means the device qualifies for a simplified licensing process but still requires product testing, audit, and documentation.

Manufacturing License Process (MD5) for Class A Devices

The MD5 license process generally spans 3 to 4 months and encompasses the following steps:

1. Apply for Test License (Form MD13): Before the manufacturing license, you must obtain a test license, which takes about 1.5 to 2 months.
2. Product Testing: Get the device tested at government-approved laboratories to confirm compliance with essential principles.
3. Documentation Preparation: Compile all required technical and quality documents.
4. Submit Application for MD5 License (Form MD3): Upload your application through the CDSCO MD Online Portal.
5. Audit by Notified Body: A mandatory audit by a notified body listed on the CDSCO Notified Bodies List assesses your manufacturing site and quality management.
6. Query Resolution: Address any observations or queries raised by the department or audit team.
7. Grant of License (Form MD5): Upon successful review, the license is granted.

Manufacturing License Documents Required for Infant Whole-Body Immobilizer

Ensure that your application includes complete and accurate documentation to avoid delays:

• Company Constitution (e.g., Memorandum of Association, Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, components, and manufacturing process (Device Master File guide)
• Plant Master File (PMF) describing manufacturing facilities and equipment (Plant Master File guide)
• Essential Principles Compliance Checklist
• Risk Management File (Risk Management insights)
• Product Test Reports from CDSCO-approved labs (Testing Laboratories list)
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (e.g., ISO 13485 Certification)

Import License Process (MD15) for Infant Whole-Body Immobilizer

If you are an importer, the process differs slightly. The MD15 import license is issued by the Central Licensing Authority and typically takes 5 to 6 months. Key points include:

• No test license required prior to application.
• Submit application via CDSCO MD Online Portal using Form MD14.
• Required documents include Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Government fees are based on the risk class and product count. For Class A devices, fees are roughly $1000 per site plus$50 per product.

For comprehensive guidance on import licensing, refer to our Import License Guide.

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): Approximately Rs. 5000
• MD5 Manufacturing License Application: Rs. 5000 per application
• Per Product Fee: Rs. 500 per product
• Audit Fees: Paid directly to notified bodies (varies, typically Rs. 50,000 – Rs. 1,00,000, depending on scope)

Budgeting accurately for these fees helps prevent surprises during the approval process.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or unclear risk management files.

Solution: Engage expert consultants early to review your Device Master File and Risk Management File. Use detailed checklists and templates to streamline preparation.

Challenge: Audit non-compliance findings leading to query backlogs.

Solution: Prepare your manufacturing site and quality systems in advance using the MD5 License Guide. Conduct internal audits to identify gaps.

Challenge: Prolonged test lab turnaround times.

Solution: Select government-approved laboratories with proven track records and consider parallel testing for multiple products.

Expert Consultation and Support

Navigating CDSCO regulations can be complex. Our seasoned team offers tailored support:

• Pre-submission gap analysis
• Documentation drafting and review
• Coordination with notified bodies and testing labs
• Application submission and follow-up
• Training on regulatory compliance and audit readiness

Our deep understanding of pediatric device nuances ensures your Infant Whole-Body Immobilizer meets all regulatory benchmarks efficiently.

Getting Started with Your CDSCO License Application

1. Confirm Device Classification: Your Infant Whole-Body Immobilizer is Class A—verify this with the Medical Device Classification resource.
2. Prepare Test License Application: Gather initial documents and apply for the test license (Form MD13) via the CDSCO MD Online Portal.
3. Identify Testing Laboratory: Choose a CDSCO-approved lab early to schedule product testing.
4. Develop Device and Plant Master Files: Leverage our guides to ensure these comply with CDSCO expectations.
5. Plan for Audit: Select an appropriate notified body from the Notified Bodies List and prepare your manufacturing site.
6. Submit MD5 Application: After completing testing and documentation, apply for your manufacturing license (Form MD3) on the CDSCO portal.
7. Respond Promptly to Queries: Maintain open communication with CDSCO officials and the notified body to expedite the approval.

Embarking on these steps with a clear roadmap and expert guidance will position your Infant Whole-Body Immobilizer for successful market entry in India.

For personalized assistance tailored to your device and business needs, connect with our regulatory experts today.