CDSCO License for Blood flowmeter catheter, Doppler
Medical Device Information
Intended Use
A flexible tube intended to be inserted into the lumen of a blood vessel to determine blood-flow velocity by measuring the ultrasonic frequency shift between transmitted and reflected signals (Doppler principle).
Comprehensive Guide to CDSCO Licensing for Blood Flowmeter Catheter, Doppler (Class C Medical Device)
As specialists with over 25 years of experience in medical device regulatory affairs in India, we have successfully assisted 500+ companies in securing CDSCO licenses. This detailed guide focuses on the Blood Flowmeter Catheter, Doppler, a Class C, interventional radiology device, regulated under notification number 29/Misc./03/2020-DC (146) dated 26.07.2021. If you are a manufacturer or importer aiming to enter the Indian market with this sophisticated medical device, understanding the regulatory framework and licensing process is crucial.
Understanding the Blood Flowmeter Catheter, Doppler
This device is a flexible catheter inserted into blood vessels to measure blood-flow velocity by utilizing the Doppler ultrasonic frequency shift principle. Given its direct interaction with the vascular system, it falls under Risk Class C according to CDSCO classification, necessitating stringent regulatory compliance.
CDSCO Regulatory Framework for Blood Flowmeter Catheter, Doppler
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Devices are categorized based on risk, with Class C devices requiring a Manufacturing License (MD9) granted by the Central Licensing Authority. The regulatory process ensures safety, efficacy, and quality before market entry.
Risk Classification and License Requirements
- Device Risk Class: C (Moderate to high risk)
- License Type: MD9 Manufacturing License
- Authority: Central Licensing Authority, CDSCO
- Application Form: MD7
The Medical Device Classification guide provides further insights into classification criteria.
Manufacturing License Process for MD9 (Class C Devices)
The MD9 license process is comprehensive and typically spans 4 to 5 months. It encompasses several stages:
- Test License (MD13): Mandatory initial step; allows limited manufacturing for testing, usually takes 1.5 to 2 months.
- Product Testing: Conducted at CDSCO-approved testing laboratories. Testing validates safety and performance.
- Documentation Preparation: Device Master File, Plant Master File, Risk Management File, Quality Management System (QMS) documents, and others.
- Application Submission: Submit Form MD7 via the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: On-site inspection focusing on GMP compliance and QMS.
- Query Resolution: Address any queries or deficiencies raised by the department or inspectors.
- Grant of License: Issuance of MD9 license in Form MD9.
Practical Tip:
Begin documentation and testing preparations concurrently to optimize the timeline. Early engagement with testing labs and notified bodies can reduce delays.
Manufacturing License Documents Required for Blood Flowmeter Catheter, Doppler
Successful MD9 application demands meticulous documentation. Key required documents include:
- Company Constitution/Registration Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualification and Experience Records
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design, manufacturing process, and performance data. Our Device Master File Guide offers detailed instructions.
- Plant Master File (PMF): Facility layout, equipment details, and quality control measures. Refer to our Plant Master File Guide.
- Essential Principles Checklist: Compliance with safety and performance standards.
- Risk Management File: Based on ISO 14971, documenting risk analysis and mitigation. Visit Risk Management for best practices.
- Test Reports: From CDSCO-approved labs confirming compliance.
- Labeling and Instructions for Use (IFU): Clear, compliant labeling and user manuals.
- Quality Management System (QMS) Documents: Evidence of ISO 13485 implementation.
Import License Process (MD15) for Blood Flowmeter Catheter, Doppler
If you are an importer, the process involves obtaining an MD15 Import License, which is handled by the Central Licensing Authority and usually takes 5 to 6 months.
Import License Process Overview:
- Prepare comprehensive documentation, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, and wholesale license.
- Submit the application using Form MD14 via the CDSCO MD Online Portal.
- Respond to any queries raised by CDSCO.
- License grant in Form MD15.
Import License Documents:
- Valid Manufacturing License of the device in the exporting country
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 1 – 1.5 months (concurrent) |
| CDSCO Audit and Inspection | 15 – 30 days |
| Query Resolution | 15 – 30 days |
| Total (MD9 License) | 4 – 5 months approx |
Government Fees and Costs
- MD9 License Application Fee: ₹50,000 per application
- Product Fee: ₹1,000 per product
These fees are payable through the CDSCO portal during application submission.
Common Challenges and Practical Solutions
Challenge 1: Delays in Testing and Audit Scheduling
- Solution: Engage early with notified testing laboratories (Testing Laboratories List) and maintain open communication with CDSCO inspectors.
Challenge 2: Incomplete or Non-compliant Documentation
- Solution: Utilize comprehensive checklists and templates for DMF, PMF, and Risk Management Files; consider expert consultation for document review.
Challenge 3: Query Resolution Delays
- Solution: Prepare clear, detailed responses supported by evidence; assign a dedicated regulatory liaison.
Challenge 4: Understanding Regulatory Updates
- Solution: Stay updated with CDSCO notifications and guidelines; subscribe to regulatory bulletins.
Expert Consultation and Support
With over two decades of regulatory expertise, we provide tailored consultancy services that streamline your CDSCO licensing journey. From pre-application audits to documentation assistance and liaison with CDSCO officials, our support mitigates risks and accelerates approvals.
Getting Started with Your CDSCO License Application
- Determine Device Classification: Confirm your device is Class C using the Medical Device Classification resource.
- Initiate Test License Application: Submit Form MD13 to commence manufacturing for testing.
- Plan Product Testing: Coordinate with CDSCO-approved testing labs early to schedule tests.
- Prepare Required Documentation: Assemble DMF, PMF, Risk Management, and QMS documents.
- Register on CDSCO MD Online Portal: Begin your formal application submission via the CDSCO MD Online Portal.
- Engage with Regulatory Experts: Consider expert guidance to preempt common pitfalls.
Embarking on the CDSCO licensing process for your Blood Flowmeter Catheter, Doppler is a significant step toward accessing the dynamic Indian healthcare market. With meticulous preparation and expert support, you can navigate the regulatory landscape efficiently and compliantly.
