CDSCO License for Microporous surgical tape

Introduction to Microporous Surgical Tape and Its Regulatory Importance

Microporous surgical tape is a staple in healthcare settings, primarily used to secure dressings and for strapping on intact skin. Classified under Class A by the Central Drugs Standard Control Organization (CDSCO), this device falls into the low-risk category but still requires strict adherence to regulatory standards for Indian market entry. Given its critical role in wound care and patient safety, securing the correct CDSCO license is essential. With over 25 years of experience and having assisted over 500 companies in navigating CDSCO licensing, we bring you detailed, actionable guidance for your microporous surgical tape licensing journey.

CDSCO Regulatory Framework for Microporous Surgical Tape

The CDSCO regulates medical devices in India under the Medical Device Rules, 2017. As per Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, microporous surgical tape is categorized under General Hospital or Orthopaedic Instruments and classified as Class A — the lowest risk category.

Manufacturers of Class A devices must obtain an MD5 manufacturing license from the State Licensing Authority to legally produce and market this device in India. Importers will require an MD15 import license from the Central Licensing Authority.

Risk Classification and License Requirements for Microporous Surgical Tape

• Risk Class: A (Low risk)
• License Type for Manufacturing: MD5 License (Application Form MD3)
• Authority: State Licensing Authority
• Timeline: Approximately 3 to 4 months (including test license and audit)
• Government Fees: Rs 5000 per application + Rs 500 per product

This classification demands compliance with essential principles, device master file submission, and a quality management system aligned with ISO 13485 standards.

Manufacturing License Process (MD5) for Microporous Surgical Tape

Obtaining the MD5 license involves several well-defined steps:

1. Test License (Form MD13): First, you must apply for a test license, which generally takes 1.5 to 2 months. This temporary license allows you to manufacture the device for testing purposes.

2. Product Testing: The microporous surgical tape must be tested at CDSCO-approved government laboratories to confirm compliance with safety and performance standards. Check the list of testing laboratories authorized for this purpose.

3. Document Preparation: Compile all required documentation, including the Device Master File and Plant Master File.

4. Application Submission: Apply for the MD5 manufacturing license using Form MD3 through the CDSCO MD Online Portal.

5. Audit: A notified body will conduct a site audit to verify compliance. You can refer to the list of notified bodies to select the appropriate auditor.

6. Query Resolution: Address any queries raised by the CDSCO or the notified body promptly.

7. Grant of License: Once all requirements are met, CDSCO issues the MD5 license (Form MD5), allowing full-scale manufacturing.

For an in-depth understanding, our detailed MD5 License Guide outlines each stage comprehensively.

Manufacturing License Documents Required for Microporous Surgical Tape

Accurate and thorough documentation is key to a smooth licensing process. For microporous surgical tape, the following are mandatory:

• Company Constitution (e.g., MOA, AOA)
• Proof of ownership or valid lease agreement of manufacturing premises
• Documents of qualified technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facility and quality controls (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with safety and performance requirements
• Risk Management File documenting hazard identification and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, ideally ISO 13485 compliant

Import License Process (MD15) for Microporous Surgical Tape

If you plan to import microporous surgical tape into India, an MD15 import license is mandatory. The process involves:

1. Document Preparation: Prepare all required documents including manufacturing license from the country of origin, Free Sale Certificate, and ISO 13485 certification.

2. Application Submission: Submit the application on Form MD14 through the CDSCO MD Online Portal.

3. Query Resolution: Respond to any queries from CDSCO promptly.

4. Grant of License: The Central Licensing Authority issues the MD15 license.

Import licenses typically take around 5 to 6 months, and fees vary by device class.

For detailed guidance, consult our Import License Guide.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution
• Proof of ownership of premises

Timeline and Processing Duration

Plan your project timelines accordingly to accommodate potential delays during document verification or audit.

Government Fees and Costs

• MD5 License Application Fee: Rs 5000 per application
• Product Fee: Rs 500 per product

Additional costs include fees for notified body audits, testing laboratory charges, and consultant fees if you engage expert services.

Common Challenges and Solutions

• Delayed Test Reports: Testing laboratories may have backlogs; early scheduling is critical.
• Incomplete Documentation: Missing or inconsistent documents can cause application rejection — use detailed checklists.
• Audit Non-Compliance: Prepare your manufacturing site in advance, ensuring all quality systems are operational.
• Query Resolution Delays: Respond promptly and comprehensively to CDSCO queries.

Our extensive experience has shown that meticulous preparation and early engagement with notified bodies and laboratories significantly reduce these hurdles.

Expert Consultation and Support

Navigating CDSCO regulations can be complex, especially for first-time manufacturers or importers. Our team, having supported 500+ companies, offers:

• End-to-end license application support
• Document preparation and review
• Quality management system implementation guidance
• Coordination with notified bodies and testing labs
• Post-license compliance and renewal assistance

Partnering with experts helps you avoid costly delays and ensures compliance with evolving regulations.

Getting Started with Your CDSCO License Application for Microporous Surgical Tape

1. Assess Your Risk Class: Confirm your device classification as Class A on the Medical Device Classification page.

2. Prepare Initial Documentation: Gather your company constitution, premises documents, and technical staff qualifications.

3. Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the submission process here.

4. Apply for Test License (Form MD13): Begin with the test license to initiate product testing.

5. Identify Accredited Testing Labs: Schedule product testing with approved labs.

6. Develop Device and Plant Master Files: Utilize our comprehensive guides to create compliant DMF and PMF.

7. Plan for Audit: Choose a notified body from the official list and prepare for inspection.

8. Submit MD5 License Application: Compile all documents and apply via the portal.

9. Engage Expert Support: Consider consulting experienced regulatory professionals to streamline your process and ensure compliance.

By following these targeted steps, your microporous surgical tape can successfully enter the Indian market under full regulatory compliance.

For personalized assistance or detailed queries, feel free to reach out to our regulatory team with over 25 years of expertise in CDSCO licensing.