CDSCO License for Fallopian tube insufflator

Comprehensive Guide to CDSCO Licensing for Fallopian Tube Insufflator (Class B Medical Device)

As specialists with over 25 years of experience in medical device regulatory affairs, we understand the complexities manufacturers and importers face when entering the Indian market. The Fallopian Tube Insufflator, classified as a Class B medical device under CDSCO regulations, requires strict adherence to regulatory frameworks to ensure patient safety and market compliance.

Understanding the Fallopian Tube Insufflator and Its Regulatory Importance

A Fallopian Tube Insufflator is an active invasive obstetrical and gynecological device designed to insufflate the Fallopian tubes, typically using carbon dioxide (CO2), to maintain tubal patency during diagnostic or therapeutic procedures. Given its invasive nature and moderate risk profile, CDSCO classifies this device as Class B, necessitating a state-level manufacturing license (MD5) or import license (MD15) for market access.

India’s regulatory landscape demands comprehensive documentation, rigorous testing, and compliance with essential principles to uphold patient safety. Our extensive experience guiding over 500 companies ensures you navigate this regulatory maze efficiently.

CDSCO Regulatory Framework for Fallopian Tube Insufflator

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. The Fallopian Tube Insufflator falls under Class B, which involves moderate risk and requires:

• Obtaining a manufacturing license (MD5) from the State Licensing Authority or
• An import license (MD15) from the Central Licensing Authority for foreign manufacturers or importers.

All applications are submitted via the CDSCO MD Online Portal, streamlining the process.

Risk Classification and License Requirements for Class B Devices

Class B devices like the Fallopian Tube Insufflator have moderate risk and are subject to the MD5 license process for manufacturing and MD15 for import. This classification reflects the device’s active invasive characteristics and patient impact.

• MD5 License (Manufacturing License for Class A & B devices): Granted by State Licensing Authority.
• MD15 License (Import License): Granted by Central Licensing Authority.

Refer to the detailed Medical Device Classification guide to confirm your device’s risk class.

Manufacturing License Process for Fallopian Tube Insufflator (MD5)

For domestic manufacturers, the MD5 license is mandatory. The process typically spans 3 to 4 months and involves several key stages:

1. Test License (Form MD13): Initially, apply for a test license to allow product testing and validation. This stage takes about 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories. Refer to the Testing Laboratories list for accredited facilities.
3. Documentation Preparation: Compile Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documentation.
4. Application Submission (Form MD3): Submit the manufacturing license application for MD5 via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body conducts onsite audits to verify compliance. You can check the list of notified bodies authorized for Class B devices.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. License Grant (Form MD5): Upon satisfactory compliance, the manufacturing license is granted.

For an in-depth understanding, our MD5 License Guide provides practical insights.

Manufacturing License Documents Required for Fallopian Tube Insufflator

Ensure the following documents are meticulously prepared and submitted:

• Company Constitution (Incorporation Certificate, Partnership Deed, or LLP Agreement)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) covering facility details and quality control systems (Plant Master File Guide)
• Essential Principles Checklist aligned with Indian MDR
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 compliance)

Import License Process for Fallopian Tube Insufflator (MD15)

Importers of Fallopian Tube Insufflators must secure an MD15 import license from the Central Licensing Authority. The process generally takes 5 to 6 months and includes:

1. Document Preparation: Collate manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and Company Constitution.
2. Application Submission (Form MD14): Submit the import license application on the CDSCO MD Online Portal.
3. Query Resolution: Respond to any queries from CDSCO to ensure clarity and compliance.
4. License Grant (Form MD15): Post verification, the import license is issued.

Refer to our detailed Import License Guide for comprehensive steps.

Import License Documents Required

• Valid 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 for distribution in India
• Company Constitution

Timeline and Processing Duration

For import license (MD15), the process spans approximately 5 to 6 months.

Government Fees and Costs

For a Class B device like the Fallopian Tube Insufflator, the fees are as follows:

• MD5 License: Rs. 5,000 per application + Rs. 500 per product
• MD15 Import License:
  • Rs. 2,000 per site
  • Rs. 1,000 per product

Note that additional costs include product testing fees at government-approved laboratories and audit fees payable to notified bodies.

Common Challenges and Solutions

• Delayed Testing Results: Coordinate early with accredited labs from the Testing Laboratories list to avoid bottlenecks.
• Incomplete Documentation: Use comprehensive checklists and templates for Device Master Files and Plant Master Files to ensure completeness.
• Audit Non-Compliance: Prepare thoroughly by conducting internal mock audits before notified body visits.
• Query Resolution Delays: Assign dedicated regulatory personnel to respond promptly to CDSCO queries.

Our practical experience has shown that proactive planning and clear communication with regulatory bodies significantly reduce approval timelines.

Expert Consultation and Support

With over 25 years of expertise and a track record of assisting 500+ companies, we provide end-to-end support for CDSCO licensing. From documentation, testing coordination, audit preparation, to regulatory submission via the CDSCO MD Online Portal, our tailored consulting accelerates your product’s market entry.

Getting Started with Your CDSCO License Application for Fallopian Tube Insufflator

1. Classify Your Device: Confirm your device is Class B using the Medical Device Classification tool.
2. Prepare Test License Application: File Form MD13 to begin product testing.
3. Select Accredited Testing Lab: Choose from CDSCO-approved labs to conduct required tests.
4. Compile Complete Documentation: Assemble Device Master File, Plant Master File, Risk Management File, and other mandatory documents.
5. Submit Manufacturing License Application: Apply using Form MD3 on the CDSCO MD Online Portal.
6. Plan for Audit: Coordinate with notified bodies early to schedule audits and prepare your facility.
7. Monitor Application Progress: Track status regularly and respond swiftly to queries.

Embarking on this process with expert guidance ensures compliance and timely approvals, paving the way for successful commercialization of your Fallopian Tube Insufflator in India.

For personalized assistance, contact us to leverage our regulatory expertise and streamline your CDSCO licensing journey.