CDSCO License for Burn sheet.

Comprehensive Guide to CDSCO Licensing for Burn Sheets (Class A Medical Device)

Burn sheets are essential medical consumables designed to wrap around burn victims, retaining body heat, absorbing wound exudate, and serving as a protective barrier against contaminants. Given their critical role in patient care, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or importing burn sheets in India.

As regulatory consultants with over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we provide you with an in-depth, actionable guide tailored specifically for burn sheets, classified as Class A devices under the CDSCO framework.

CDSCO Regulatory Framework for Burn Sheets

Burn sheets fall under the category of General Hospital or Orthopaedic Instruments as per the CDSCO medical device classification system. As a Class A device (low risk), the regulatory pathway involves obtaining a Manufacturing License (MD5) from the State Licensing Authority or an Import License (MD15) from the Central Licensing Authority if importing.

The governing notification for burn sheets is 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022, which formally recognizes the device and sets the regulatory expectations.

Understanding this classification and framework is crucial for compliance and market entry.

Risk Classification and License Requirements for Burn Sheets

• Device Name: Burn Sheet
• Risk Class: A (Low Risk)
• Intended Use: To retain body heat, absorb wound exudates, and protect against contamination in burn victims
• License Type: MD5 Manufacturing License (for domestic manufacturing)
• Regulatory Authority: State Licensing Authority

For Class A devices like burn sheets, the MD5 license is mandatory for manufacturing within India. This license is issued after completion of testing, documentation, and an audit by a notified body.

Manufacturing License Process (MD5) for Burn Sheets

The MD5 licensing process for Class A devices is structured and typically requires 3 to 4 months end-to-end. Here’s the stepwise breakdown:

1. Apply for a Test License (MD13): Initial step to legally manufacture the device for testing purposes. This takes roughly 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing of burn sheets at CDSCO-approved government testing laboratories to validate safety and performance.
3. Documentation Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and others.
4. Submit MD5 Application (Form MD3): Submit application via the CDSCO MD Online Portal along with necessary documents.
5. Audit by Notified Body: Engage a notified body for a mandatory audit. Check the list of notified bodies for approved agencies.
6. Queries and Clarifications: Address any observations or queries raised by CDSCO or the notified body promptly.
7. Grant of License: Upon satisfactory compliance, the State Licensing Authority issues the MD5 license (Form MD5).

Practical Tip:

Engage with a notified body early in the process to understand specific audit requirements and avoid delays.

Manufacturing License Documents Required for Burn Sheets

The documentation package is critical for the application’s success. For burn sheets (Class A), you must prepare:

• Company Constitution and Incorporation Documents
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, manufacturing process, and specifications. Our comprehensive Device Master File guide can assist.
• Plant Master File (PMF) describing the manufacturing facility and quality systems. See our Plant Master File guide.
• Essential Principles Checklist affirming compliance with Indian medical device standards
• Risk Management File demonstrating hazard analysis and mitigation strategies. Learn more about risk management.
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, ideally ISO 13485 certified

Pro Tip:

Ensure all documentation is consistent and reflects the latest manufacturing processes and product specifications to avoid audit observations.

Import License Process (MD15) for Burn Sheets

If you plan to import burn sheets into India, an MD15 Import License is required from the Central Licensing Authority.

The process includes:

• Comprehensive document preparation (including Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate if applicable)
• Submission of application on Form MD14 via the CDSCO MD Online Portal
• Resolution of any departmental queries
• Grant of MD15 license

The entire import license process takes approximately 5 to 6 months.

Required Documents for Import License:

• Valid Manufacturing License from the exporting country
• Free Sale Certificate
• ISO 13485 Certification
• CE Marking Certificate
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution

For detailed guidance, our Import License Guide provides pragmatic insights.

Timeline and Processing Duration

Understanding this timeline helps manufacturers plan production and market launch effectively.

Government Fees and Costs

For Burn Sheets (Class A), the fee structure is as follows:

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs include:

• Testing fees at government-approved labs (varies by test complexity)
• Notified body audit charges (typically INR 50,000 to 1,00,000 depending on scope)
• Consultancy and documentation preparation fees (if outsourced)

Budgeting for these expenses upfront can prevent surprises during the licensing process.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Select CDSCO-approved labs in advance and schedule testing promptly after the test license is granted.

Challenge 2: Incomplete or Inconsistent Documentation

• Solution: Use detailed checklists and templates to prepare Device and Plant Master Files. Regular internal audits help maintain document integrity.

Challenge 3: Audit Non-Compliance

• Solution: Conduct pre-audit mock inspections and corrective action plans to ensure readiness.

Challenge 4: Query Resolution Delays

• Solution: Assign a dedicated regulatory expert to respond to CDSCO queries promptly with supporting evidence.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex, especially for first-time manufacturers or importers. With our 25+ years of regulatory consulting experience and over 500 successful CDSCO licenses facilitated, we provide:

• End-to-end application management
• Documentation preparation and review
• Coordination with notified bodies and testing labs
• Audit readiness and corrective action support
• Post-license regulatory compliance guidance

Partnering with experts reduces risk, accelerates approval, and ensures sustained compliance.

Getting Started with Your CDSCO License Application for Burn Sheets

1. Assess Your Device Classification: Confirm burn sheets as Class A under CDSCO’s classification.
2. Apply for Test License (MD13): Begin application via the CDSCO MD Online Portal.
3. Identify Testing Laboratories: Coordinate product testing early by referring to the CDSCO Testing Laboratories list.
4. Prepare Documentation: Utilize expert templates for Device Master File, Plant Master File, Risk Management File, and QMS.
5. Engage a Notified Body: Schedule your audit with a notified body from the official list.
6. Submit MD5 Application: Once testing and documentation are complete, submit your application on the MD Online Portal.
7. Respond to Queries Promptly: Maintain open communication channels with CDSCO officials.

Starting early and following a structured approach ensures timely licensing and smooth market entry for your burn sheets.

For further personalized assistance or to discuss your specific product needs, please contact our regulatory experts. We are committed to helping you navigate CDSCO licensing with confidence and efficiency.