CDSCO License for Endoscopic needleless submucosal lift catheter
Medical Device Information
Intended Use
A sterile, flexible tube intended to non-invasively deliver a submucosal lifting solution into the submucosa of the gastrointestinal tract through a flexible endoscope during an endoscopic procedure (e.g., gastroscopy, colonoscopy) to lift a lesion, typically for subsequent excision.
Introduction to Endoscopic Needleless Submucosal Lift Catheter and Regulatory Importance
The Endoscopic Needleless Submucosal Lift Catheter is a specialized, sterile medical device designed for gastroenterological procedures. It facilitates the non-invasive delivery of submucosal lifting solutions during endoscopy, such as gastroscopy or colonoscopy, aiding in lesion lifting for excision. Given its critical clinical role and classification as a Class B device under CDSCO regulations, obtaining the proper manufacturing or import license is essential to legally market this device in India.
Navigating the CDSCO regulatory framework can be complex. With over 25 years of experience assisting 500+ companies, we understand the intricacies involved in acquiring your CDSCO license efficiently and compliantly.
CDSCO Regulatory Framework for Endoscopic Needleless Submucosal Lift Catheters
India regulates medical devices like the Endoscopic Needleless Submucosal Lift Catheter through the Central Drugs Standard Control Organization (CDSCO). This device falls under Class B (low-moderate risk) as per the Medical Device Classification guidelines, necessitating a manufacturing license (MD5) issued by the State Licensing Authority.
The regulatory framework requires compliance with the Medical Device Rules (MDR), 2017, and adherence to quality management systems, testing, and documentation before market entry.
Risk Classification and License Requirements
- Device Risk Class: B (Low to Moderate Risk)
- License Type: MD5 Manufacturing License (Form MD3)
- Issuing Authority: State Licensing Authority
- Total Timeline: Approximately 3-4 months
This licensing path includes mandatory steps such as obtaining a Test License (Form MD13), product testing by government-approved labs, document compilation, notified body audits, and finally, license grant.
Manufacturing License Process (MD5)
- Apply for Test License (Form MD13): Submit initial application to obtain permission to manufacture and test your device. This process takes about 1.5 to 2 months.
- Product Testing: Conduct product testing at CDSCO-recognized government laboratories to demonstrate compliance with applicable standards. Refer to the list of testing laboratories.
- Documentation Preparation: Compile comprehensive documents, including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
- Submit MD5 Application (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal.
- Audit by Notified Body: Undergo an on-site audit by a notified body listed on the Notified Bodies List.
- Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
- License Grant: Upon satisfactory compliance, the MD5 license is granted, allowing commercial manufacture.
For an in-depth understanding, our MD5 License Guide covers detailed steps.
Manufacturing License Documents Required
To streamline your application, ensure the following documents are ready and compliant:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire Safety NOC
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing processes (Device Master File Guide)
- Plant Master File (PMF) outlining manufacturing environment and quality systems (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with safety and performance requirements
- Risk Management File documenting hazard analysis and mitigation (Risk Management)
- Test Reports from government-approved laboratories
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Endoscopic Needleless Submucosal Lift Catheter
For importers, the MD15 license is mandatory and issued by the Central Licensing Authority. The process includes:
- Document preparation including Manufacturing License from country of origin, Free Sale Certificate, and ISO 13485:2016 certification
- Application submission on the CDSCO MD Online Portal
- Resolution of any departmental queries
- License grant, taking approximately 5-6 months
Relevant documents include Manufacturing License, Free Sale Certificate, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
Refer to our Import License Guide for comprehensive details.
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks (varies) |
| Document Preparation | 3 to 4 weeks |
| Application Submission | Immediate after docs ready |
| Notified Body Audit | Scheduled within 1 month |
| Query Resolution | 2 to 4 weeks |
| License Grant (MD5) | Within 1 month post audit |
Total time from start to finish typically spans 3 to 4 months for Class B devices.
Government Fees and Costs
- Test License Fee: Included in application process
- MD5 Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
Additional costs may include notified body audit fees, testing laboratory charges, and consulting fees if external expertise is engaged.
Common Challenges and Solutions
- Delayed Product Testing: Early coordination with notified testing laboratories can mitigate delays. Utilize the Testing Laboratories List to select appropriate facilities.
- Incomplete Documentation: Strict adherence to document checklists, including DMF and PMF, reduces back-and-forth with authorities.
- Audit Non-Compliance: Pre-audit internal assessments and readiness checks ensure smooth notified body evaluations.
- Query Resolution Delays: Prompt and detailed responses supported by robust documentation help accelerate license grant.
Our team has successfully navigated these hurdles with clients, ensuring timely approvals.
Expert Consultation and Support
With over 25 years of regulatory consulting experience, we provide tailored support for your Endoscopic Needleless Submucosal Lift Catheter licensing journey. From initial documentation to audit preparation and query management, our experts guide you step-by-step.
Engage with us early to leverage our proven strategies and avoid common pitfalls. Our expertise includes preparing Device and Plant Master Files, implementing risk management systems, and coordinating with CDSCO and notified bodies.
Getting Started with Your CDSCO License Application
- Assess Product Classification: Confirm Class B status using CDSCO guidelines.
- Initiate Test License Application (Form MD13): Prepare initial documentation and submit via the CDSCO MD Online Portal.
- Select Testing Laboratory: Identify suitable government-approved labs early for product testing.
- Prepare Comprehensive Documentation: Use our guides on Device Master File and Plant Master File preparation.
- Plan for Notified Body Audit: Schedule and prepare for the audit after testing and documentation are complete.
- Submit MD5 License Application (Form MD3): Once all prerequisites are met, apply online.
Starting with these actionable steps will position your company for a smooth and timely CDSCO MD5 license approval, enabling you to manufacture and market your Endoscopic Needleless Submucosal Lift Catheter in India confidently.
For personalized support, contact our regulatory team today to discuss your project roadmap and compliance requirements.
