CDSCO License for Intrauterine imaging  medium catheterization kit

Comprehensive Guide to CDSCO Licensing for Intrauterine Imaging Medium Catheterization Kit (Class B)

As seasoned regulatory consultants with over 25 years of experience and more than 500 successful CDSCO license approvals, we understand the critical importance of navigating India's regulatory landscape efficiently. If you manufacture or import the Intrauterine Imaging Medium Catheterization Kit, a Class B obstetrical and gynecological device intended for sterile intrauterine injection of opaque tracer medium to facilitate radiography of fallopian tubes/uterus, this guide is tailored for you.

Understanding the Device and Its Regulatory Importance

This catheterization kit plays a vital role in diagnostic radiography within gynecology, making sterility and traceability paramount. Given its classification as a Class B device under CDSCO guidelines, compliance with Indian regulatory standards ensures patient safety and market access.

CDSCO Regulatory Framework for Intrauterine Imaging Medium Catheterization Kits

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India, categorizing devices into Class A, B, C, and D based on risk. Your device falls under Class B, which is considered low to moderate risk. The licensing authority for manufacturing Class B devices is the State Licensing Authority, and applications follow the MD5 license process.

You can submit your application seamlessly through the CDSCO MD Online Portal.

Risk Classification and License Requirements

• Risk Class: B
• Applicable License: MD5 (Manufacturing License for Class A and B Devices)
• Application Form: MD3
• Authority: State Licensing Authority

This classification mandates adherence to specific quality assurance protocols, including obtaining a Test License (MD13) prior to final manufacturing license approval.

Manufacturing License Process (MD5) for Class B Devices

The MD5 licensing process generally spans 3 to 4 months and involves the following key steps:

1. Test License Application (Form MD13)

   • Apply for a test license to manufacture the device on a trial basis.
   • Processing time: Approximately 1.5 to 2 months.

2. Product Testing at Government-Approved Laboratories

   • Conduct mandatory product testing at labs listed on the CDSCO Testing Laboratories portal.
   • Testing ensures compliance with essential performance and safety standards.

3. Documentation Preparation

   • Compile comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and others.

4. Application Submission for MD5 License (Form MD3)

   • Submit the manufacturing license application online.

5. Audit by Notified Body

   • A notified body conducts an on-site audit verifying compliance.
   • Reference the list of notified bodies for audit arrangements.

6. Query Resolution

   • Address any queries raised by the licensing authority or notified body promptly.

7. Grant of MD5 License

   • Upon satisfactory review, the license is granted, allowing commercial manufacturing.

Manufacturing License Documents Required

To ensure a smooth approval process, prepare the following documents meticulously:

• Company Constitution (e.g., Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety and Pollution Control NOCs
• Device Master File detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File describing facility infrastructure and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File demonstrating hazard identification and mitigation (Risk Management Guide)
• Product Test Reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, ideally ISO 13485:2016 certification

Import License Process (MD15) for Intrauterine Imaging Medium Catheterization Kit

If you intend to import this device into India, an MD15 Import License issued by the Central Licensing Authority is mandatory. The process typically takes around 5 to 6 months and involves:

• Document preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE Certificate (if applicable), Device and Plant Master Files, and Wholesale License.
• Submission of application on the CDSCO MD Online Portal.
• Query resolution and final license grant.

For detailed insights, refer to our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License for distribution in India
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

• MD5 License Fees: ₹5,000 per application plus ₹500 per product
• Test License Fees (MD13): Charged separately, typically ₹5,000
• Testing Charges: Varies by laboratory and number of tests; budget for ₹50,000 – ₹1,00,000 approximately
• Audit Fees: Paid directly to notified bodies; varies by scope

Budget accordingly to avoid unexpected delays.

Common Challenges and Practical Solutions

Challenge: Delays due to incomplete documentation or non-compliance in audits.

Solution: Engage experienced consultants for pre-audit readiness checks and thorough documentation review. Use our detailed MD5 License Guide to align your application with regulatory expectations.

Challenge: Waiting for government-approved lab testing slots.

Solution: Schedule testing early during the test license period and maintain open communication with testing labs listed on the CDSCO Testing Laboratories portal.

Challenge: Understanding risk management requirements.

Solution: Implement comprehensive risk management per ISO 14971 standards, using resources like our Risk Management Guide.

Expert Consultation and Support

Navigating CDSCO’s regulatory system can be complex. Our consultancy has empowered over 500 companies to successfully obtain and maintain their licenses. We offer end-to-end support—from device classification, documentation, test license procurement to audit preparation and post-approval compliance.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm your device is Class B using the Medical Device Classification tool.
2. Apply for Test License: Prepare and submit Form MD13 through the CDSCO MD Online Portal.
3. Schedule Testing: Book slots at CDSCO-approved testing labs.
4. Prepare Documentation: Compile Device Master File, Plant Master File, Risk Management File, and QMS documents.
5. Engage a Notified Body: Identify and notify a suitable body for the audit.
6. Submit MD5 Application (Form MD3): Once test license and testing are complete.
7. Prepare for Audit: Conduct internal audits and gap analysis.
8. Respond to Queries Promptly: Maintain clear communication with CDSCO.

By following these steps and leveraging our expert insights, you can optimize your chances for timely approval and successful market entry.

For personalized assistance and comprehensive support, connect with our regulatory experts today and ensure your intrauterine imaging medium catheterization kit complies fully with CDSCO requirements.