CDSCO License for Fallopian tube biopsy everting-balloon catheter
Medical Device Information
Intended Use
A sterile device intended to be inserted through a hysteroscope to obtain biopsy samples from a fallopian tube for cytological examination.
Understanding the Fallopian Tube Biopsy Everting-Balloon Catheter and Its Regulatory Importance
The fallopian tube biopsy everting-balloon catheter is a specialized sterile medical device designed for insertion through a hysteroscope to collect biopsy samples from the fallopian tube, crucial for cytological examination in gynecological diagnostics. Given its direct interaction with internal tissues and the sensitive nature of its use, this device is classified as a Class B medical device under Indian regulations, indicating moderate risk.
Navigating the regulatory landscape for such devices is essential for ensuring patient safety, compliance, and smooth market entry in India. With over 25 years of experience and having assisted more than 500 companies, we provide you with a detailed roadmap tailored specifically for this device.
CDSCO Regulatory Framework for Fallopian Tube Biopsy Everting-Balloon Catheters
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. This device falls under the Obstetrical and Gynecological category and is regulated under the Medical Device Rules (MDR), 2017.
As per the official notification File No. 29/Misc./03/2020-DC (181), dated 03.6.2022, the device must comply with the standards and licensing requirements laid down for Class B devices. Compliance ensures the device meets safety, efficacy, and quality benchmarks.
Risk Classification and License Requirements for Class B Devices
Class B devices like the fallopian tube biopsy everting-balloon catheter are considered moderate risk. According to the Medical Device Rules, manufacturing licenses for Class B devices are granted through the State Licensing Authority via the MD5 license process.
Key points:
- License Type: MD5 (Application Form MD3)
- Authority: State Licensing Authority
- Total processing time: Approximately 3-4 months
- Fees: ₹5,000 per application + ₹500 per product
You can learn more about device classification on our detailed Medical Device Classification guide.
Manufacturing License Process (MD5) for Fallopian Tube Biopsy Everting-Balloon Catheters
Test License Application (Form MD13): The first step involves obtaining a test license, which takes around 1.5 to 2 months. This allows the device to be legally manufactured for testing purposes.
Product Testing: Post test license approval, your device samples must be tested at CDSCO-approved testing laboratories to verify compliance with essential principles and standards. You can find a list of such Testing Laboratories here.
Document Preparation: Comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents must be prepared.
License Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: The State Licensing Authority will coordinate an audit by a notified body to verify compliance. Check the list of notified bodies authorized to conduct audits.
Query Resolution: Address any queries or deficiencies raised during the audit or by CDSCO.
License Grant: Upon satisfactory compliance, the MD5 license will be granted, enabling full-scale manufacturing.
For a step-by-step overview, refer to our MD5 License Guide.
Manufacturing License Documents Required for the Device
To ensure a smooth and successful application, prepare the following key documents:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Valid Lease Agreement for Manufacturing Premises
- Documents of Qualified Technical Staff (Biomedical Engineers, QA Personnel, etc.)
- 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 the manufacturing facility and quality controls (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with safety and performance requirements
- Risk Management File demonstrating hazard identification and mitigation strategies (Risk Management)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485 certification recommended)
Attention to detail in documentation significantly reduces processing delays.
Import License Process (MD15) for Fallopian Tube Biopsy Everting-Balloon Catheters
If you are an importer, the CDSCO requires an MD15 import license granted by the Central Licensing Authority. The process entails:
- Document preparation (including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485, CE certificate, Device and Plant Master Files, wholesale license, and company constitution)
- Application submission on the CDSCO MD Online Portal
- Resolution of queries raised by CDSCO
- License grant within approximately 5-6 months
Government fees vary by device class; for Class B devices, expect ₹2,000 per site and ₹1,000 per product.
For a comprehensive import license overview, visit our Import License Guide.
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 4 weeks |
| License Application (MD5) | 1 – 2 weeks |
| Audit and Inspection | 3 – 4 weeks |
| Query Resolution | 2 – 3 weeks |
| Total Time | 3 – 4 months |
Planning ahead and preparing documents in parallel can shorten overall timelines.
Government Fees and Costs
- Test License (MD13): Included within the application process
- MD5 Manufacturing License Application: ₹5,000 per application
- Per Product Fee: ₹500
- Testing Costs: Vary by device and lab; typically ₹50,000 – ₹1,00,000 per product batch
- Audit Fees: Charged by notified bodies; ranges from ₹50,000 to ₹1,00,000 depending on scope
Budgeting for these costs upfront helps avoid unforeseen expenses.
Common Challenges and Solutions
Incomplete Documentation: Ensure all technical files, certifications, and test reports are up to date and aligned with CDSCO requirements.
Delays in Testing: Coordinate early with CDSCO-approved labs to book slots and clarify testing protocols.
Audit Non-compliance: Conduct internal pre-audits to prepare your facility and processes.
Query Resolution Delays: Respond promptly and comprehensively to any CDSCO or notified body queries.
Understanding Complex Regulations: Engage expert consultants familiar with the MDR 2017 to navigate regulatory nuances efficiently.
Expert Consultation and Support
With over 25 years of experience and 500+ successful CDSCO license procurements, we specialize in guiding manufacturers and importers of obstetrical and gynecological devices like the fallopian tube biopsy everting-balloon catheter. Our tailored approach helps you:
- Prepare thorough and compliant documentation
- Coordinate with testing laboratories and notified bodies
- Navigate audit processes smoothly
- Optimize timelines and manage costs effectively
Our team stays updated with CDSCO notifications and regulatory amendments, ensuring your compliance remains current.
Getting Started with Your CDSCO License Application
To initiate your licensing journey:
Assess Device Classification: Confirm your device’s risk class and licensing pathway.
Prepare Technical Documentation: Begin compiling your Device Master File, Plant Master File, Risk Management File, and QMS documents.
Apply for Test License (MD13): Submit your test license application through the CDSCO MD Online Portal.
Engage with Testing Labs: Schedule product testing at CDSCO-approved laboratories.
Schedule Pre-Audit Reviews: Conduct internal audits to identify gaps before the notified body inspection.
Submit Manufacturing License Application (MD5): After successful testing, apply for your manufacturing license.
Maintain Communication: Track your application status and respond to any queries promptly.
We recommend early engagement with regulatory consultants to streamline this process. Contact us to leverage our expertise and ensure your fallopian tube biopsy everting-balloon catheter reaches the Indian market compliantly and efficiently.
