CDSCO License for Ultrasonic maging  Catheter

Comprehensive Guide to CDSCO Licensing for Ultrasonic Imaging Catheter (Class B)

Ultrasonic Imaging Catheters are specialized medical devices used primarily for ultrasound examination of peripheral pathology. Classified as Class B under Indian regulations, these catheters require adherence to CDSCO’s stringent regulatory framework to ensure safety and efficacy before entering the Indian market. With over 25 years of experience assisting 500+ companies in obtaining CDSCO licenses, we provide you an expert roadmap optimized for Ultrasonic Imaging Catheters.

CDSCO Regulatory Framework for Ultrasonic Imaging Catheters

Under the Medical Device Rules, 2017 and subsequent notifications, Ultrasonic Imaging Catheters fall under Class B due to their moderate risk profile. The CDSCO mandates manufacturers to obtain a manufacturing license (MD5) from the State Licensing Authority before production and sale. For importers, an import license (MD15) from the Central Licensing Authority is necessary.

The key regulations applicable include:

• Medical Device Rules, 2017
• Notification No. 29/Misc/3/2017-DC (292), dated 06.06.2018

Familiarity with the Medical Device Classification is essential to verify device risk class and applicable licensing routes.

Risk Classification and License Requirements for Class B Catheters

Class B devices, including Ultrasonic Imaging Catheters, require:

• MD5 Manufacturing License (Form MD3) granted by the State Licensing Authority
• Prior test license (MD13) for product testing
• Certification of compliance with essential principles and risk management

This contrasts with Class C/D devices, which require central licensing (MD9). Class B devices typically take 3-4 months for the entire manufacturing license process.

Manufacturing License Process (MD5) for Ultrasonic Imaging Catheters

The MD5 licensing process involves several sequential steps:

1. Test License Application (Form MD13): Before manufacturing license application, obtain a test license to allow sample production for testing. This usually takes 1.5-2 months.

2. Product Testing: Conduct mandatory tests at CDSCO-approved laboratories. For Ultrasonic Imaging Catheters, this includes biocompatibility, electrical safety, and performance validation. Refer to the Testing Laboratories list for accredited labs.

3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.

4. Application Submission: Apply via the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body: The State Licensing Authority mandates an audit by a notified body. Select an authorized body from the Notified Bodies List for the MD5 audit.

6. Query Resolution: Address any queries raised by the licensing authority or notified body.

7. License Grant: Upon successful audit and documentation review, the MD5 license is granted.

For an in-depth walkthrough, see our MD5 License Guide.

Manufacturing License Documents Required

To streamline your application, prepare the following critical documents:

• Company Constitution: Incorporation certificate, partnership deed, or Memorandum of Association
• Proof of Premises Ownership: Lease agreement or sale deed
• Technical Staff Details: Qualifications and experience certificates
• Fire NOC & Pollution Control NOC: Compliance with local safety norms
• Device Master File (DMF): Detailed device design, manufacturing processes, and specifications (Guide to DMF)
• Plant Master File (PMF): Description of manufacturing facility and quality systems (PMF Guide)
• Essential Principles Checklist: Demonstrating compliance with Indian essential principles
• Risk Management File: Evidence of risk analysis and mitigation (Risk Management Insights)
• Test Reports: From CDSCO-approved labs
• Labels and Instructions for Use (IFU): Compliant with CDSCO labeling guidelines
• Quality Management System (QMS) Documents: ISO 13485 certification and SOPs

Ensuring accuracy and completeness of these documents accelerates the licensing process.

Import License Process (MD15) for Ultrasonic Imaging Catheters

If you plan to import Ultrasonic Imaging Catheters into India, an MD15 import license from CDSCO’s Central Licensing Authority is mandatory. Unlike the manufacturing license, a test license is not required.

The import license process includes:

1. Document Preparation: Collate manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device and Plant Master Files, wholesale license, and company incorporation documents.

2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution: Respond promptly to CDSCO queries.

4. License Grant: Typically issued within 5-6 months.

For detailed guidance, refer to our Import License Guide.

Timeline and Processing Duration

For imports (MD15), the timeline extends to approximately 5-6 months.

Government Fees and Costs

For Class B Ultrasonic Imaging Catheters, fees are as follows:

• MD5 Manufacturing License:

  • Application fee: Rs 5,000
  • Per product fee: Rs 500

• Test License (MD13): Separate nominal fee applicable

Costs for testing and notified body audits depend on scope and can vary; budgeting Rs 2-3 lakhs is prudent.

For imports (MD15), fees vary by risk class and number of products; expect approximately $2,000 per site and$1,000 per product for Class B devices.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with essential principles.

Solution: Engage experienced consultants early to prepare robust Device and Plant Master Files and comprehensive risk management documentation.

Challenge: Difficulty scheduling audits with notified bodies.

Solution: Pre-book audit slots and maintain open communication with notified bodies from the approved list.

Challenge: Test failures or inconsistent lab reports.

Solution: Utilize CDSCO-approved testing labs and pre-validate products internally to avoid surprises.

Expert Consultation and Support

Navigating CDSCO licensing for Ultrasonic Imaging Catheters can be complex. Our team has successfully guided over 500 manufacturers and importers through every step—from initial documentation to audit closure—ensuring timely approvals.

We offer:

• Detailed gap analysis of your documentation
• Coordination with notified bodies and testing labs
• Regulatory strategy tailored to your product and business model
• Post-license compliance support

Getting Started with Your CDSCO License Application for Ultrasonic Imaging Catheters

1. Assess your device classification: Confirm Class B status using CDSCO guidance.
2. Prepare initial documentation: Start compiling your Device Master File and Plant Master File.
3. Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
4. Plan product testing: Engage CDSCO-approved labs early.
5. Select notified body for audit: Choose from the official list and schedule your audit.
6. Submit MD5 application: Once testing is complete, apply via Form MD3.
7. Respond promptly to queries: Expedite your application by timely clarifications.

Our extensive experience and structured approach can help you avoid common pitfalls and accelerate your market entry. Contact us today to initiate your Ultrasonic Imaging Catheter licensing journey with confidence.