CDSCO License for Catheter-balloon inflator, reusable
Medical Device Information
Intended Use
A device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure.
Introduction to Catheter-Balloon Inflator (Reusable) and Its Regulatory Importance
A reusable catheter-balloon inflator is a critical medical device used primarily in gastroenterology procedures. It allows healthcare professionals to manually inflate and regulate the pressure of balloon catheters, facilitating safe and controlled interventions. Given its direct interaction with patients and invasive nature, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is essential to ensure safety, efficacy, and quality.
At our consultancy, with over 25 years of experience assisting 500+ companies, we understand the intricacies involved in obtaining CDSCO licenses for devices like the catheter-balloon inflator, classified as a Class B device under Indian regulations. This guide provides a detailed roadmap for manufacturers and importers aiming to launch this device in the Indian market.
CDSCO Regulatory Framework for Catheter-Balloon Inflators
The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, which categorize devices based on risk classes. The catheter-balloon inflator falls under Class B (low moderate risk), as per Notification 29/Misc./03/2020-DC (182) dated 27.09.2021. This classification mandates specific licensing requirements, quality management systems, and compliance with essential principles.
Manufacturers of reusable catheter-balloon inflators must secure the MD5 manufacturing license issued by the State Licensing Authority, while importers require the MD15 import license from the Central Licensing Authority.
Risk Classification and License Requirements for Class B Devices
Class B devices, including the reusable catheter-balloon inflator, require an MD5 manufacturing license under Form MD3. This license ensures that the manufacturing processes comply with safety and quality standards suitable for low to moderate risk devices.
Key points:
- License Type: MD5 (Manufacturing License for Class A & B devices)
- Issuing Authority: State Licensing Authority
- Application Form: MD3
- Typical Processing Time: 3-4 months (including test license and audit)
- Fees: Rs. 5,000 per application + Rs. 500 per product
Manufacturing License Process (MD5) for Reusable Catheter-Balloon Inflators
The stepwise process for obtaining an MD5 license for your catheter-balloon inflator involves:
Test License (Form MD13): Before the manufacturing license, apply for a test license to legally manufacture and test the device. This typically takes 1.5 to 2 months.
Device Testing: Conduct product testing at CDSCO-approved laboratories to verify compliance with applicable standards. Testing laboratories can be found on the CDSCO Testing Laboratories list.
Documentation Preparation: Compile all required documents, including technical files, quality management system evidence, and risk management documentation.
License Application Submission: Submit the manufacturing license application on the CDSCO MD Online Portal using Form MD3.
Audit by Notified Body: An audit of the manufacturing facility and quality systems is conducted by a notified body listed here.
Query Resolution: Address any queries raised by the state licensing authority or notified body promptly.
License Grant: Upon satisfactory completion, the license on Form MD5 is granted, allowing commercial manufacturing.
For a detailed understanding, refer to our comprehensive MD5 License Guide.
Manufacturing License Documents Required for Catheter-Balloon Inflator
To ensure a smooth application process, prepare the following key documents:
- Company Constitution (e.g., Memorandum of Association, Articles of Association)
- Proof of ownership or lawful possession of manufacturing premises
- Details and qualifications of technical staff involved in manufacturing
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) outlining design, specifications, and manufacturing process (Device Master File Guide)
- Plant Master File describing the manufacturing environment and processes (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with MDR requirements
- Risk Management File demonstrating hazard identification and mitigation (Risk Management)
- Test Reports from CDSCO-recognized laboratories
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, typically ISO 13485:2016 certification
Import License Process (MD15) for Catheter-Balloon Inflators
If you plan to import catheter-balloon inflators into India, an MD15 import license issued by the Central Licensing Authority is mandatory. The process involves:
Document Preparation: Collect all necessary certifications including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate if applicable, DMF, PMF, and wholesale license.
Application Submission: Apply via the CDSCO MD Online Portal using Form MD14.
Evaluation & Queries: The CDSCO reviews the application and may raise queries.
License Grant: After satisfactory review, the MD15 license is granted.
The entire process typically takes 5-6 months. For detailed guidance, see our Import License Guide.
Import License Documents Required
Key documents for MD15 include:
- Valid Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License in India
- Company Constitution
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Application Preparation | 2 - 3 weeks |
| Audit and Inspection | 3 - 4 weeks |
| Query Resolution | 2 - 4 weeks |
| License Grant (MD5) | Total 3 - 4 months |
For imports (MD15), expect 5 - 6 months overall.
Government Fees and Costs
- MD5 License: Rs. 5,000 per application + Rs. 500 per product
- Test License (MD13): Fees applicable as per CDSCO norms
Additional costs to consider:
- Testing laboratory fees (varies based on tests required)
- Audit fees charged by notified bodies
- Consultancy fees if using expert services
Common Challenges and Solutions
Delayed Testing Results: Coordinate early with CDSCO-approved labs and schedule tests promptly.
Incomplete Documentation: Use a detailed checklist and expert review to avoid missing critical files.
Audit Non-compliance: Prepare your facility and QMS rigorously; consider pre-audit assessments.
Query Delays: Respond promptly and comprehensively to queries from authorities.
Understanding Classification: Confirm device classification using the Medical Device Classification tool to avoid misfiling.
Expert Consultation and Support
With decades of regulatory experience and over 500 successful CDSCO license applications, our team offers:
- Comprehensive gap analysis for your device and facility
- Document preparation and review
- Coordination with testing labs and notified bodies
- Representation during audits and inspections
- Post-approval compliance support
Our expertise ensures you navigate the regulatory landscape efficiently, minimizing delays and risks.
Getting Started with Your CDSCO License Application
To initiate your MD5 manufacturing license application for the reusable catheter-balloon inflator:
Register on the CDSCO MD Online Portal.
Apply for the Test License (Form MD13): Start manufacturing and testing legally.
Identify a CDSCO-approved testing laboratory for your product.
Prepare your Device Master File and Plant Master File carefully.
Schedule a notified body audit early to align timelines.
Compile all required documents as per the checklist.
Submit your MD5 license application (Form MD3) and monitor application status.
By following these actionable steps, you position your catheter-balloon inflator for timely market entry in India. Contact us for personalized assistance and to leverage our proven track record in CDSCO licensing success.
