CDSCO License for Endoscope tissue removal cap

Comprehensive Guide to CDSCO Licensing for Endoscope Tissue Removal Cap (Class B Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized devices like the Endoscope Tissue Removal Cap. As a sterile plastic tube used during electrosurgical treatments in gastroenterology, this device falls under Risk Class B according to CDSCO regulations. With over 25 years of experience and having assisted 500+ companies in obtaining CDSCO licenses, we provide you with practical, detailed guidance to streamline your licensing journey.

CDSCO Regulatory Framework for Endoscope Tissue Removal Cap

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017, amended over time to enhance safety and compliance. The Endoscope Tissue Removal Cap is classified as a Class B device, defined by moderate risk, requiring a manufacturing license from the State Licensing Authority (SLA) through the MD5 license process.

This device's category falls under Gastroenterology, and it has been notified under Notification 29/Misc./03/2020-DC (182) dated 27.09.2021, ensuring explicit regulatory clarity.

Risk Classification and License Requirements for Class B Devices

Class B devices like the Endoscope Tissue Removal Cap require adherence to specific regulatory protocols:

• License Type: MD5 Manufacturing License (Form MD3)
• Issuing Authority: State Licensing Authority
• Test License Required: Yes, MD13 Test License prior to full manufacturing license
• Testing Required: Mandatory testing from CDSCO-approved government laboratories
• Audit: Conducted by notified bodies as per CDSCO guidelines

For comprehensive understanding, refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Endoscope Tissue Removal Cap

The MD5 license process involves several critical steps:

1. Test License Application (Form MD13): Apply for a test license to manufacture the device for testing purposes.
2. Product Testing: Send the device samples to CDSCO-approved testing laboratories. A list of Testing Laboratories is available on the CDSCO MD Online Portal.
3. Document Preparation: Compile required documents including Device Master File and Plant Master File.
4. Application for Manufacturing License (Form MD3): Submit via the CDSCO MD Online Portal.
5. Audit by Notified Body: The notified body will perform a comprehensive audit of your manufacturing facility and quality systems. You can check the list of notified bodies authorized for audits.
6. Resolution of Queries: Address any observations or deficiencies raised by the notified body or CDSCO.
7. Grant of MD5 License: Upon satisfactory compliance, the license is granted.

Manufacturing License Documents Required

For your Endoscope Tissue Removal Cap, ensure you have the following documents ready:

• Certificate of Incorporation and Company Constitution
• Proof of ownership or lease of manufacturing premises
• Qualification documents of technical staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File outlining facility infrastructure and equipment (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety standards
• Risk Management File demonstrating hazard identification and mitigation (Risk Management)
• Test reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 compliance recommended)

Import License Process (MD15) for Endoscope Tissue Removal Cap

If you are an importer intending to bring the Endoscope Tissue Removal Cap into the Indian market, the MD15 Import License is mandatory. This license is issued by the Central Licensing Authority and has the following key points:

• Application Form: MD14
• No Test License Required: Unlike manufacturing, import does not require an initial test license.
• Documents Required: Manufacturing License from country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016 certification, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Fees: Vary by device class, with Class B devices typically attracting $2000 per site and$1000 per product.
• Process Duration: Approximately 5-6 months

Detailed steps and document checklists are available in our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or equivalent
• ISO 13485:2016 Quality Management System Certificate
• CE Marking Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for distribution
• Company Constitution and Board Resolution

Timeline and Processing Duration

For import licenses (MD15), expect 5-6 months due to central authority processing.

Government Fees and Costs

• MD5 License (Class B):
  • Rs 5,000 per application
  • Rs 500 per product
• MD13 Test License: Included in overall fees, typically no separate charge

Additional costs to consider:

• Testing fees at government-approved labs
• Audit fees payable to notified bodies
• Documentation preparation and consultancy (if applicable)

Common Challenges and Solutions

• Delay in Test Reports: Testing can be delayed due to lab backlogs. Early sample submission and follow-up with testing labs can minimize delays.
• Incomplete Documentation: Ensure thorough document preparation, referencing our Device Master File and Plant Master File guides.
• Audit Non-compliance: Conduct internal audits and gap assessments before the notified body visit.
• Query Resolution Delays: Assign dedicated resources to respond promptly to CDSCO queries.

Expert Consultation and Support

Our team has successfully guided over 500 manufacturers and importers through the CDSCO regulatory process for devices identical and similar to the Endoscope Tissue Removal Cap. We provide:

• Comprehensive gap analysis and readiness assessment
• Documentation preparation and review
• Coordination with notified bodies and testing labs
• End-to-end application filing and follow-up

Partnering with experienced consultants can significantly reduce your time to market and compliance risks.

Getting Started with Your CDSCO License Application

1. Evaluate Your Device Classification: Confirm your device is Class B under the CDSCO MDR.
2. Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
3. Coordinate Product Testing: Identify and engage with a CDSCO-approved testing lab early.
4. Prepare Required Documentation: Use our linked guides to develop robust Device and Plant Master Files.
5. Schedule Notified Body Audit: Select an appropriate notified body from the list here and prepare for inspection.
6. Submit Manufacturing License Application (Form MD3): After successful testing and audit, submit your application via the CDSCO portal.
7. Respond to Queries Promptly: Assign a dedicated team to handle any clarifications.

Starting early and working systematically will help you meet regulatory requirements efficiently and successfully launch your Endoscope Tissue Removal Cap in India.

For personalized support and detailed walkthroughs, reach out to our expert regulatory team committed to your success in CDSCO licensing.