CDSCO License for Ultrasonic pulsed doppler imaging system
Medical Device Information
Intended Use
An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion.
Comprehensive Guide to CDSCO Licensing for Ultrasonic Pulsed Doppler Imaging Systems
Ultrasonic pulsed doppler imaging systems, classified under Class B medical devices, are essential tools in interventional radiology. These devices leverage continuous wave doppler-effect combined with pulsed-echo technology to assess both stationary and dynamic tissue characteristics, such as blood velocity and tissue interfaces. Given their critical diagnostic role, obtaining a CDSCO license is vital for manufacturers and importers aiming to enter the Indian market. With over 25 years of experience and having assisted 500+ companies, we provide an expert roadmap to help you navigate this process efficiently.
CDSCO Regulatory Framework for Ultrasonic Pulsed Doppler Imaging Systems
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Devices Rules, 2017. Ultrasonic pulsed doppler imaging systems fall under the risk Class B category as per the CDSCO medical device classification. This classification mandates a manufacturing license through Form MD3 (MD5 license) granted by the State Licensing Authority.
The regulatory framework includes thorough evaluation of device safety, performance, and quality management systems compliance before granting licenses for manufacturing or import.
Risk Classification and License Requirements
- Risk Class: B (Low to moderate risk)
- License Type: MD5 Manufacturing License (Application Form MD3)
- Regulatory Authority: State Licensing Authority
- Test License: Mandatory MD13 Test License before MD5 application
- Inspection: Audit by notified bodies
The notified CDSCO notification governing ultrasonic pulsed doppler imaging systems is 29/Misc./03/2020-DC (146), dated 26.07.2021, which you must reference in your application.
Manufacturing License Process (MD5)
The manufacturing license process for Class B devices involves several sequential steps:
- Obtain MD13 Test License: Apply for a test license to manufacture the device for testing purposes; this usually takes 1.5 to 2 months.
- Product Testing: Conduct product testing at government-approved laboratories to demonstrate compliance with essential principles.
- Prepare Documentation: Compile all technical and quality documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and QMS documentation.
- Submit MD5 Application: Apply on the CDSCO MD Online Portal using Form MD3.
- Audit by Notified Body: Undergo a detailed audit by a notified body (find the list of notified bodies here), focusing on manufacturing practices and quality systems.
- Respond to Queries: Address any queries or deficiencies raised by the department or the auditor promptly.
- License Grant: Upon satisfactory review, the MD5 license will be issued.
Manufacturing License Documents Required
To ensure a smooth review, prepare the following key documents:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Qualifications and Experience Details of Technical Staff
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (Refer to our comprehensive Device Master File guide)
- Plant Master File (Plant Master File Guide)
- Essential Principles Checklist
- Risk Management File (Risk Management Guidance)
- Product Test Reports from CDSCO-approved labs (Testing Laboratories List)
- Labeling and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation, typically ISO 13485:2016 compliant
Import License Process (MD15)
For importers of ultrasonic pulsed doppler imaging systems, the process is managed centrally:
- License Type: MD15 Import License (Application Form MD14)
- Authority: Central Licensing Authority under CDSCO
- Timeline: Approximately 5-6 months
- Test License: Not required for import
- Documents: Manufacturing License of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, Company Constitution
Submit your application through the CDSCO MD Online Portal. The process involves document scrutiny and resolution of departmental queries before license issuance.
Import License Documents Required
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate or Equivalent
- ISO 13485:2016 Certification
- CE Certificate or other international approvals
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Estimated Duration |
|---|---|
| MD13 Test License | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Documentation Preparation | 2 - 3 weeks |
| MD5 License Application Review | 1.5 - 2 months |
| Notified Body Audit | 2 - 3 weeks |
| Query Resolution | 2 - 4 weeks |
| Total Manufacturing License Time | 3 to 4 months |
Import license processing generally takes 5 to 6 months due to centralized scrutiny.
Government Fees and Costs
- MD5 License Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
- MD13 Test License Fee: Included in test license application
Additional costs to consider:
- Product testing fees at government-approved labs
- Audit fees charged by notified bodies
- Consultancy fees if engaging regulatory experts
Common Challenges and Solutions
Challenge 1: Delay in Testing Reports
- Solution: Engage with CDSCO-approved testing labs early and confirm timelines; maintain close communication.
Challenge 2: Incomplete Documentation
- Solution: Use detailed checklists and our Device Master File guide to ensure completeness.
Challenge 3: Audit Non-compliance
- Solution: Conduct internal audits and pre-audit readiness checks before notified body visits.
Challenge 4: Query Resolution Delays
- Solution: Assign dedicated personnel for prompt responses and maintain clear, documented communication.
Expert Consultation and Support
With over 25 years of experience and 500+ successful CDSCO license approvals, our team offers tailored support:
- End-to-end license application management
- Documentation preparation and review
- Internal audit and compliance readiness
- Liaison with notified bodies and CDSCO officials
Our proactive approach minimizes delays and helps you avoid common pitfalls.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device is Class B using the CDSCO classification tool.
- Initiate Test License Application: Apply for MD13 test license on the CDSCO MD Online Portal.
- Schedule Product Testing: Engage with a CDSCO-approved testing laboratory early.
- Prepare Documentation: Compile the Device Master File, Plant Master File, Risk Management File, and QMS documents.
- Select a Notified Body: Refer to the list of notified bodies and initiate the audit process.
- Submit MD5 Application: Complete and upload the Form MD3 through the CDSCO portal.
- Manage Queries Efficiently: Assign a dedicated team member to handle CDSCO or notified body queries.
Embarking on the licensing journey with thorough preparation and expert support significantly enhances your chances of timely approval. Contact us today to leverage our expertise and secure your Ultrasonic Pulsed Doppler Imaging System license with confidence.
