CDSCO License for Negative pressure wound therapy bandage

Comprehensive Guide to CDSCO Licensing for Negative Pressure Wound Therapy Bandages (Class C Medical Device)

Negative Pressure Wound Therapy (NPWT) bandages are critical medical devices designed to accelerate wound healing by applying controlled negative pressure to the wound bed. This therapy effectively removes exudates, infection materials, and tissue debris, promoting faster regeneration and reducing infection risks. Given their therapeutic impact, CDSCO classifies NPWT bandages under Class C (moderate to high risk) devices, specifically under the catheter category, regulated as per Notification 29/Misc/3/2017-DC (18) dated 16.08.2018.

As regulatory consultants with over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we understand the nuances and challenges manufacturers and importers face. This guide will walk you through every critical step—from classification to license grant—for your NPWT bandage to enter the Indian market smoothly.

CDSCO Regulatory Framework for Negative Pressure Wound Therapy Bandages

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Devices Rules 2017. NPWT bandages fall under Class C devices due to their invasive nature and clinical risk. This classification places them under direct oversight of the Central Licensing Authority, which ensures stringent compliance with safety, efficacy, and quality standards before market entry.

Understanding this framework is essential because each risk class—A, B, C, or D—has specific licensing pathways, documentation needs, and timelines. For your NPWT bandage, the process requires an MD9 manufacturing license for domestic production or an MD15 import license if you are importing.

For detailed classification insights, refer to our Medical Device Classification resource.

Risk Classification and License Requirements for NPWT Bandages

• Device Name: Negative Pressure Wound Therapy Bandage
• Risk Class: C
• Category: Catheters
• Regulatory Route:
  • Manufacturing: MD9 License (Form MD7)
  • Import: MD15 License (Form MD14)

Class C devices demand compliance with higher regulatory scrutiny than Class A/B but less than Class D. The MD9 manufacturing license is issued by the CDSCO Central Licensing Authority and requires a comprehensive audit and testing process.

Manufacturing License Process (MD9) for Class C Devices

The MD9 license process involves multiple stages:

1. Test License (Form MD13): Initially, applicants must obtain a test license valid for 6 months to manufacture and test the device.
2. Product Testing: Samples must be tested in CDSCO-approved laboratories to validate safety and performance.
3. Documentation Preparation: Assemble technical files including Device Master File, Plant Master File, Risk Management files, and QMS documents.
4. Application Submission: Apply for MD9 license via Form MD7 on the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: CDSCO conducts a thorough audit of manufacturing facilities and quality systems.
6. Query Resolution: Address any observations or queries raised during audit or application review.
7. License Grant: Upon satisfactory compliance, CDSCO grants the MD9 manufacturing license.

The entire process from test license application to license grant generally takes 4-5 months.

For a detailed MD9 licensing walkthrough, visit our MD9 License Guide.

Manufacturing License Documents Required for NPWT Bandages

To comply with CDSCO's requirements, prepare the following key documents:

• Company Constitution Documents: Certificate of Incorporation, Memorandum & Articles of Association
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Qualifications and Experience
• No Objection Certificates (NOCs): Fire Safety, Pollution Control
• Device Master File (DMF): Detailed design, specifications, manufacturing process, and validation data (See our Device Master File Guide)
• Plant Master File (PMF): Infrastructure and quality systems overview (Plant Master File Guide)
• Essential Principles Checklist: Demonstrating compliance with safety and performance standards
• Risk Management File: Hazard analysis, risk evaluation, and mitigation plans (Risk Management Insights)
• Test Reports: From CDSCO-approved testing laboratories (Testing Laboratories List)
• Labels and Instructions for Use (IFU): Conforming to regulatory norms
• Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs

Attention to detail in documentation is critical to avoid delays or rejections.

Import License Process (MD15) for NPWT Bandages

For importers, the MD15 license is mandatory. The process involves:

1. Documentation Compilation: Similar to manufacturing, plus import-specific documents like Free Sale Certificate and CE Certificate.
2. Application Submission: File Form MD14 via the CDSCO MD Online Portal.
3. Application Scrutiny and Query Resolution: CDSCO reviews the dossier and raises queries.
4. Grant of Import License (Form MD15): Upon satisfactory review, the license is issued.

The import license takes approximately 5-6 months.

More details are available in our Import License Guide.

Import License Documents Required

• Valid Manufacturing License (MD9) from the country of origin
• Free Sale Certificate from the country of origin regulatory agency
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License (if applicable in India)
• Company Constitution Documents

Note that government fees vary by device risk class.

Timeline and Processing Duration for Class C NPWT Bandages

For imports, the process is slightly longer at 5-6 months due to additional scrutiny.

Government Fees and Costs

• MD9 Manufacturing License:

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

• Test License (MD13): Usually included in the above costs but confirm with CDSCO.

• MD15 Import License:

  • Site Fee (Class C): USD 3,000
  • Product Fee (Class C): USD 1,500

Investing in accurate documentation and expert support can reduce re-submissions and expedite approvals.

Common Challenges and Practical Solutions

1. Incomplete or Inaccurate Documentation

Many applicants fail to provide comprehensive Device Master Files or Risk Management documentation. We recommend early consultation and thorough cross-checking using our Device Master File Guide and Risk Management resources.

2. Delays in Product Testing

Testing labs can have backlogs. Engage CDSCO-approved labs proactively and schedule sample submissions early. Check the Testing Laboratories List to select suitable labs.

3. Facility Audit Non-compliance

Ensure your manufacturing site adheres strictly to GMP and ISO 13485 standards. Pre-audit internal assessments can help avoid non-conformities.

4. Responding to Regulatory Queries

Timely and detailed responses to CDSCO queries are essential. Prepare clear technical explanations and corrective action plans.

Expert Consultation and Support

Navigating CDSCO regulations for Class C devices like NPWT bandages requires specialized expertise. Our team has successfully steered over 500 companies through the entire lifecycle—from test license acquisition to final license grant. We provide:

• Tailored documentation preparation
• Liaison with CDSCO authorities
• Audit readiness coaching
• Regulatory strategy consulting

Engaging expert support reduces risk of rejection and accelerates market entry.

Getting Started with Your CDSCO License Application for NPWT Bandages

1. Assess Your Device Classification: Confirm that NPWT bandage falls under Class C as per the latest CDSCO notifications.
2. Register on the CDSCO MD Online Portal: This is mandatory for all applications.
3. Prepare Essential Documents: Follow our guides on Device Master File and Plant Master File creation.
4. Apply for Test License (MD13): Initiate manufacturing and testing permissions.
5. Plan Product Testing: Coordinate with CDSCO-approved labs.
6. Compile Complete Dossier: Include Risk Management and Essential Principles checklist.
7. Submit MD9 License Application (Form MD7): After successful testing.
8. Prepare for CDSCO Audit: Schedule and conduct internal pre-audits.
9. Respond Promptly to Queries: Maintain open communication with CDSCO.

By following these detailed, stepwise actions and leveraging expert regulatory support, manufacturers and importers can confidently secure their CDSCO licenses for Negative Pressure Wound Therapy Bandages and successfully access the Indian healthcare market.

For personalized assistance, please contact our regulatory consulting team to streamline your licensing journey.