CDSCO License for Catheter-tip transducer, pressure
Medical Device Information
Intended Use
A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure.
Comprehensive CDSCO Licensing Guide for Catheter-tip Transducer, Pressure (Class B Medical Device)
As a medical device regulatory consulting firm with over 25 years of experience and a successful track record of assisting 500+ companies, we understand the critical importance of securing timely and compliant CDSCO licensing for your medical device. This guide focuses specifically on the catheter-tip transducer, pressure, classified as a Class B device under the Obstetrical and Gynecological category, and provides detailed, actionable insights to help manufacturers and importers enter the Indian market with confidence.
Introduction: Catheter-tip Transducer and Its Regulatory Importance
A catheter-tip transducer is a highly specialized medical device intended for integration into the distal end of a catheter to measure pressure within the human body. Due to its vital role in obstetrical and gynecological procedures, the device’s safety, accuracy, and compliance with Indian regulations are paramount. The Central Drugs Standard Control Organization (CDSCO) supervises the regulatory framework ensuring only safe and effective medical devices reach Indian healthcare providers.
CDSCO Regulatory Framework for Catheter-tip Transducer, Pressure
Under the latest CDSCO regulations, catheter-tip transducers fall under Class B, representing a low to moderate risk category. This classification mandates a manufacturing license known as the MD5 license, issued by the State Licensing Authority. The process involves thorough documentation, product testing, and an audit by a notified body to confirm compliance with Indian Essential Principles and international standards.
Risk Classification and License Requirements
- Device Risk Class: B (low to moderate risk)
- Regulatory License: MD5 (Manufacturing License for Class A and B devices)
- Applicable Notification: File No. 29/Misc./03/2020-DC (181) dated 03.06.2022
The MD5 license process includes obtaining a test license (Form MD13) before full manufacturing approval, followed by product testing and a notified body audit.
Manufacturing License Process (MD5) for Catheter-tip Transducer
- Apply for Test License (Form MD13): Initiate your journey by applying for a test license. This step takes approximately 1.5 to 2 months and authorizes limited production for testing purposes.
- Product Testing: Get your catheter-tip transducer tested at CDSCO-approved laboratories to validate safety and performance. Refer to the list of testing laboratories for accredited options.
- Document Preparation: Compile comprehensive dossiers including Device Master File, Plant Master File, Essential Principles checklist, and Risk Management File.
- Submit MD5 License Application (Form MD3): Apply through the CDSCO MD Online Portal with all mandatory documents.
- Audit by Notified Body: A notified body conducts an on-site audit to verify compliance. The list of approved auditors is available on the Notified Bodies List.
- Query Resolution: Respond promptly to any queries raised by the CDSCO or the notified body.
- License Grant: Upon satisfactory evaluation, the State Licensing Authority issues the MD5 manufacturing license.
Manufacturing License Documents Required
For your catheter-tip transducer MD5 application, prepare the following:
- Company Constitution documents
- Proof of ownership or lease of manufacturing premises
- Technical staff qualifications and experience
- Fire and Pollution NOCs
- Device Master File (DMF) detailing design and specifications (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing facilities (Plant Master File Guide)
- Essential Principles Checklist conforming to CDSCO requirements
- Risk Management File outlining hazard analysis and mitigation (Risk Management)
- Test reports from approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485 certified
Import License Process (MD15) for Catheter-tip Transducer
If you intend to import the catheter-tip transducer instead of manufacturing locally, the MD15 import license is mandatory. This license is granted by the Central Licensing Authority and typically takes 5 to 6 months. Unlike manufacturing, a test license is not required, but the application must include robust evidence of compliance including:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE marking or equivalent
- Device Master and Plant Master Files
- Wholesale license
- Company Constitution
The import application is submitted via the CDSCO MD Online Portal using Form MD14.
Import License Documents Required
- Valid Manufacturing License of the exporting country
- Free Sale Certificate or Certificate of Marketability
- ISO 13485:2016 Certification
- CE Certificate or equivalent international certification
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution and address proof
Timeline and Processing Duration
| License Type | Timeline | Key Steps |
|---|---|---|
| Test License (MD13) | 1.5 to 2 months | Application, evaluation, grant |
| Manufacturing (MD5) | 3 to 4 months | Testing, audit, query resolution |
| Import License (MD15) | 5 to 6 months | Document review, query resolution |
Overall, expect approximately 3-4 months to obtain your MD5 license for the catheter-tip transducer, including test license and audit.
Government Fees and Costs
- MD5 License: Rs 5,000 per application + Rs 500 per product
- Test License (MD13): Separate application fees as applicable
- Import License (MD15):
- Class B device fees: Rs 1,50,000 per site + Rs 1,000 per product (converted approx from USD)
Budget for additional costs such as notified body audit fees, testing laboratory charges, and document preparation assistance.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all technical files, test reports, and compliance documents are thorough and up-to-date. Utilize our detailed Device Master File Guide to prepare accurate dossiers.
- Delayed Testing: Choose CDSCO-approved labs early and schedule testing promptly to avoid bottlenecks.
- Audit Readiness: Conduct internal audits prior to the notified body visit to identify gaps.
- Query Management: Respond to CDSCO queries promptly with clear, evidence-backed explanations.
Expert Consultation and Support
Navigating the CDSCO licensing landscape can be complex. Our seasoned regulatory consultants offer end-to-end support, from initial classification and dossier preparation to audit facilitation and post-license compliance. With over 500 successful client engagements, we tailor strategies specifically for devices like the catheter-tip transducer.
Getting Started with Your CDSCO License Application
- Classify Your Device: Confirm the Class B status per the official Medical Device Classification guidelines.
- Prepare Documentation: Start compiling Device and Plant Master Files alongside QMS and Risk Management documentation.
- Apply for Test License: Submit your Form MD13 application via the CDSCO MD Online Portal and schedule product testing.
- Coordinate with Notified Body: Engage a notified body early for audit planning.
- Submit MD5 Application: Upon successful test results, file your Form MD3 application.
By following this structured approach and leveraging expert support, manufacturers and importers can successfully obtain their CDSCO MD5 license for the catheter-tip transducer, ensuring regulatory compliance and market access in India.
For personalized assistance and detailed guidance, contact our regulatory team today to streamline your CDSCO licensing journey.
