CDSCO License for Salpngography  Catheter

Comprehensive Guide to CDSCO Licensing for Salpingography Catheter (Class B Medical Device)

As specialists with over 25 years of experience in medical device regulatory affairs, we understand the critical importance of timely and accurate CDSCO licensing for medical devices like the Salpingography Catheter. This catheter is specifically designed for the injection of contrast medium into the fallopian tubes during salpingography procedures, falling under the Class B risk category. Navigating the CDSCO regulatory framework can be complex, but with our expert guidance, manufacturers and importers can confidently and efficiently secure the necessary approvals to enter the Indian market.

CDSCO Regulatory Framework for Salpingography Catheter

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Given the Salpingography Catheter's classification as a Class B device (medium risk), the regulatory pathway involves obtaining an MD5 manufacturing license or an MD15 import license, depending on your business model. The device falls under the catheter category and is regulated as per the notification 29/Misc/3/2017-DC (292) dated 06.06.2018.

Understanding and complying with CDSCO regulations is essential to ensure product safety, efficacy, and market access. The process requires adherence to comprehensive documentation, product testing, audits, and fee payments.

Risk Classification and License Requirements for Salpingography Catheter

The Salpingography Catheter, classified as a Class B device, is considered a low to moderate risk medical device. As per CDSCO rules:

• Manufacturing License: MD5 License, issued by the State Licensing Authority
• Import License: MD15 License, issued by the Central Licensing Authority

Class B devices require a Test License (Form MD13) before the manufacturing license application. This ensures the device undergoes necessary testing at government-approved laboratories.

For detailed classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process for Salpingography Catheter (MD5 License)

The MD5 manufacturing license process is tailored for Class A and B devices and involves several key steps:

1. Test License Application (Form MD13): Apply via the CDSCO MD Online Portal to obtain a test license. This license permits sample testing and is valid for 6 months.
2. Product Testing: Submit samples of the Salpingography Catheter to government-approved testing laboratories. A list of such labs is available on the CDSCO website.
3. Document Preparation: Compile all required documents including Device Master File, Plant Master File, and Risk Management File.
4. License Application (Form MD3): Submit the manufacturing license application on the CDSCO portal.
5. Audit by Notified Body: The manufacturing site undergoes an audit by a notified body from the official list.
6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
7. Grant of MD5 License: Upon satisfaction, CDSCO issues the manufacturing license (Form MD5).

The entire process typically takes 3 to 4 months, including the test license period.

Practical Tips:

• Begin documentation and testing preparations early to avoid delays.
• Maintain open communication with the notified body to expedite audits.
• Ensure compliance with Essential Principles and submit a comprehensive Risk Management File as per medical device risk management best practices.

Manufacturing License Documents Required for Salpingography Catheter

To streamline your application, ensure the following documents are prepared and validated:

• Company Constitution (Registration Certificate)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (Guide on DMF)
• Plant Master File (PMF) describing the manufacturing environment and quality controls (Guide on PMF)
• Essential Principles Compliance Checklist
• Risk Management File
• Valid Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification preferred)

Completeness and accuracy of these documents significantly reduce the back-and-forth during the review.

Import License Process for Salpingography Catheter (MD15 License)

For importers, the MD15 license is mandatory to legally import Salpingography Catheters into India. The process includes:

1. Document Preparation: Assembling the required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and more.
2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
3. Review and Query Resolution: CDSCO will review and raise queries if needed; prompt and detailed responses are critical.
4. Grant of MD15 License: Upon satisfaction, CDSCO grants the import license.

The import license process generally spans 5 to 6 months.

Import License Documents Required:

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale Drug License
• Company Constitution

Government fees depend on device class and number of products:

• Class B devices typically incur Rs 2000 per site plus Rs 1000 per product.

For more details on the import license, see our Import License Guide.

Timeline and Processing Duration

Total Manufacturing License Time: Approximately 3 to 4 months

Total Import License Time: Approximately 5 to 6 months

Government Fees and Costs

• MD5 Manufacturing License: Rs 5000 per application + Rs 500 per product
• MD15 Import License: Rs 2000 per site + Rs 1000 per product (Class B)

Additional costs to budget for include testing fees at government-approved labs, audit fees charged by notified bodies, and consultancy fees if applicable.

Common Challenges and Solutions

Challenge 1: Delays in Test License Approval

• Solution: Submit a complete and error-free application early; track status on the CDSCO MD Online Portal.

Challenge 2: Incomplete Documentation Leading to Queries

• Solution: Use detailed checklists and expert reviews to ensure document completeness before submission.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal pre-audits and train staff on regulatory expectations.

Challenge 4: Extended Query Resolution Period

• Solution: Prepare prompt, clear, and evidence-backed responses; engage regulatory consultants if necessary.

Expert Consultation and Support

With a proven track record of assisting over 500 companies, we provide end-to-end CDSCO licensing support—from initial classification, documentation preparation, test license acquisition, to audit readiness and final license grant. Our expertise ensures risk mitigation and accelerates your time to market.

Getting Started with Your CDSCO License Application for Salpingography Catheter

1. Confirm Device Classification: Verify your product’s Class B status through CDSCO guidelines.
2. Register on CDSCO MD Online Portal: Begin by creating your account at cdscomdonline.gov.in.
3. Apply for Test License (MD13): Submit your application for the test license to start product testing.
4. Engage Testing Labs: Coordinate sample testing with government-approved laboratories.
5. Prepare Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and other essential documents.
6. Schedule Audit: Contact and schedule an audit with a notified body from the official list of notified bodies.
7. Submit Manufacturing License Application (Form MD3): File your application with all supporting documents.
8. Monitor Application Progress: Use the online portal to track status and respond swiftly to queries.

Our team is ready to guide you through each step, ensuring compliance and a smooth licensing journey for your Salpingography Catheter. Reach out to us today to begin the process with confidence.