CDSCO License for Invasive silicone sheet dressing

Comprehensive Guide to CDSCO Licensing for Invasive Silicone Sheet Dressing (Risk Class B)

As seasoned regulatory consultants with over 25 years of experience assisting more than 500 medical device manufacturers and importers, we understand the complexities involved in securing CDSCO licensing for innovative devices like the invasive silicone sheet dressing. This device, classified as Class B under Indian regulations, is critical for temporary abdominal closure in gastroenterology surgeries, and its safe market introduction depends heavily on compliance with the Central Drugs Standard Control Organization (CDSCO) framework.

Understanding the Device: Invasive Silicone Sheet Dressing

The invasive silicone sheet dressing is a sterile, flat silicone elastomer used intra-abdominally post-surgery to facilitate short-term wound management and planned re-exploration within 30 days. This device plays a vital role in preventing complications associated with open abdomen conditions, making regulatory compliance and quality assurance essential.

CDSCO Regulatory Framework for Invasive Silicone Sheet Dressing

In India, all medical devices must be registered and licensed under the Medical Devices Rules, 2017, administered by CDSCO. Given that the invasive silicone sheet dressing is a Class B device, the applicable licensing pathway is the MD5 manufacturing license, issued by the State Licensing Authority.

Risk Classification and License Requirements for Class B Devices

Class B devices are considered low to moderate risk. According to the notified classification under notification 29/Misc./03/2020-DC (182) dated 27.09.2021, your invasive silicone sheet dressing falls squarely into this category. This classification mandates adherence to the following:

Obtain a Test License (Form MD13) before full manufacturing license application.
Conduct product testing at CDSCO-approved laboratories.
Submit a comprehensive application for the MD5 manufacturing license (Form MD3).

For detailed information on classification and compliance, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process involves several structured steps:

Application for Test License (Form MD13): Required before manufacturing for testing purposes. This initial license usually takes 1.5 to 2 months to be granted.
Product Testing: The invasive silicone sheet dressing must be tested at government-approved labs to verify safety and performance. You can find the list of such Testing Laboratories here.
Documentation Preparation: Assemble all required documents, including Device Master File and Plant Master File.
Submission of Manufacturing License Application (Form MD3): File your application through the CDSCO MD Online Portal with all supporting evidence.
Audit by a Notified Body: An onsite audit by a notified body is mandatory. Check the list of notified bodies for audit assignments.
Query Resolution: Address any deficiencies or queries raised by the department or notified body.
Grant of MD5 License: Upon satisfactory review and audit, the license is granted on Form MD5.

The entire process typically spans 3 to 4 months from test license application to final license issuance.

Manufacturing License Documents Required

To streamline your application, prepare the following essential documentation:

Company Constitution and Incorporation Certificates
Proof of Ownership or Lease of Manufacturing Premises
Details and Qualifications of Technical Staff
Fire NOC and Pollution Control NOC
Device Master File (DMF): Detailed device specifications, manufacturing processes, and quality controls. Our Device Master File Guide offers valuable insights.
Plant Master File (PMF): Comprehensive information on manufacturing facilities. Learn more in our Plant Master File Guide.
Essential Principles Checklist compliance document
Risk Management File showing implementation of risk control measures. Refer to our Risk Management guide for best practices.
Product Test Reports from CDSCO-approved labs
Labels and Instructions for Use (IFU)
Quality Management System (QMS) Documents, ideally ISO 13485 compliant

Import License Process (MD15) for Invasive Silicone Sheet Dressing

If you plan to import this device into India, a separate MD15 import license issued by the Central Licensing Authority is mandatory. The process includes:

Compilation of import-specific documents such as Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), and your manufacturing license.
Submission of application on the CDSCO MD Online Portal.
Processing time is approximately 5 to 6 months.

For a complete breakdown of the import license process, visit our Import License Guide.

Import License Documents Required

Valid Manufacturing License (MD5 or MD9)
Free Sale Certificate from the country of origin
ISO 13485:2016 Certificate
CE Certificate or any other applicable regulatory certificate
Device Master File
Plant Master File
Wholesale License (if applicable)
Company Constitution and Incorporation Certificates

Timeline and Processing Duration

Step	Duration
Test License (MD13)	1.5 to 2 months
Product Testing	1 to 1.5 months
Document Preparation	2 to 3 weeks
Submission and Audit	1 to 1.5 months
Query Resolution and License Grant	2 to 3 weeks

Total Time for MD5 Licensing: Approximately 3 to 4 months

Government Fees and Costs

Test License Fee: Included within application processing
MD5 Manufacturing License Fees:
- Rs 5,000 per application
- Rs 500 per product (for your single invasive silicone sheet dressing product, Rs 500 applies)

Additional costs may include fees for product testing at approved laboratories and notified body audit charges.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Schedule testing early and select government-approved laboratories with shortest turnaround. Pre-verify testing requirements to avoid repeats.

Challenge 2: Documentation Gaps

Solution: Use comprehensive checklists for DMF and PMF preparation. Our guides provide templates and best-practice documentation frameworks.

Challenge 3: Audit Non-Compliance

Solution: Conduct internal audits before notified body visits. Ensure trained technical staff are present and QMS processes are well-documented.

Challenge 4: Query Resolution Delays

Solution: Respond promptly and thoroughly to CDSCO queries with supporting evidence. Engage experienced consultants for technical clarifications.

Expert Consultation and Support

Navigating CDSCO licensing can be daunting, especially for specialized devices like the invasive silicone sheet dressing. Our team offers end-to-end support—from test license application to final MD5 license grant. We ensure compliance alignment, audit readiness, and timely submissions to minimize delays and costs.

Getting Started with Your CDSCO License Application

Assess Your Device Classification: Confirm your device is Class B using official notifications.
Prepare Documentation Early: Start compiling your Device Master File and Plant Master File using expert guides.
Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
Coordinate Product Testing: Engage with CDSCO-approved labs promptly.
Plan for Notified Body Audit: Select notified bodies and schedule audits early.

By following these practical steps and leveraging our decades of regulatory expertise, manufacturers and importers can successfully obtain the MD5 license for invasive silicone sheet dressings and smoothly enter the Indian medical device market.

For personalized assistance, detailed checklists, and application support, contact us today and let us help you navigate the CDSCO licensing journey with confidence.

CDSCO License for Invasive silicone sheet dressing

Medical Device Information

Intended Use