CDSCO License for Catheter-balloon inflator, single-use

Introduction to Catheter-Balloon Inflator Regulatory Requirements

The catheter-balloon inflator, single-use, is a critical medical device used predominantly in gastroenterology. Designed to manually inflate and regulate pressure within balloon catheters during procedures, this sterile device ensures precise control and patient safety. Given its direct clinical application, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) in India is paramount for manufacturers and importers aiming to market this device.

Over our 25+ years of experience assisting over 500 companies in CDSCO licensing, we understand that navigating the regulatory pathway for Class B devices like the catheter-balloon inflator requires detailed knowledge of documentation, timelines, and procedural nuances. This guide provides a comprehensive overview and actionable insights to facilitate a smooth licensing process.

CDSCO Regulatory Framework for Catheter-Balloon Inflators

Under the Medical Device Rules (MDR) 2017, notified under the Drugs and Cosmetics Act, catheter-balloon inflators fall under Class B risk classification due to their invasive nature but lower risk compared to Class C or D devices. Compliance with these rules ensures device safety, efficacy, and quality.

Regulatory oversight for manufacturing licenses of Class B devices is managed by the State Licensing Authority via the MD5 license process. Import licenses, if applicable, are handled by the Central Licensing Authority through MD15 licensing.

The device is listed under the notification number 29/Misc./03/2020-DC (182), dated 27.09.2021, highlighting its classification and regulatory status.

Risk Classification and License Requirements for Catheter-Balloon Inflators

• Risk Class: B (Low to moderate risk)
• License Type: MD5 Manufacturing License
• Application Form: MD3
• Licensing Authority: State Licensing Authority

This classification mandates manufacturers to first obtain a Test License (Form MD13), conduct mandatory product testing in government-approved laboratories, prepare required technical documentation, undergo audit by a notified body, and finally apply for the manufacturing license.

For detailed risk class information, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Catheter-Balloon Inflators

1. Test License Application (Form MD13): This initial step takes approximately 1.5 to 2 months. It allows the manufacturer to legally produce the device samples required for testing.
2. Product Testing: Mandatory testing must be performed at CDSCO-recognized testing laboratories. A list of these labs is accessible via the CDSCO Testing Laboratories directory.
3. Document Preparation: Compile all technical and compliance documents including Device Master File, Plant Master File, and Quality Management System (QMS) documents.
4. License Application Submission (Form MD3): File the MD5 license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An on-site audit is conducted by a notified body listed on the Notified Bodies List to verify compliance.
6. Resolution of Queries: Address any observations or queries raised by the CDSCO or notified body promptly.
7. Grant of MD5 Manufacturing License: Upon satisfactory compliance, the license is issued on Form MD5.

Our detailed MD5 License Guide provides step-by-step insights and best practices.

Manufacturing License Documents Required for Catheter-Balloon Inflators

Manufacturers must prepare and submit the following documents:

• Company Constitution documents (e.g., incorporation certificate)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, specifications, and manufacturing processes. Learn more in our Device Master File Guide
• Plant Master File (PMF) describing manufacturing facilities and equipment. See our Plant Master File Guide
• Essential Principles Checklist (compliance with safety and performance requirements)
• Risk Management File demonstrating hazard analysis and mitigation strategies. Read our Risk Management insights
• Product Test Reports from CDSCO-accredited labs
• Device labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, ideally aligned with ISO 13485:2016 standards

Import License Process (MD15) for Catheter-Balloon Inflators

Though manufacturers primarily require MD5 licenses, importers of catheter-balloon inflators must obtain an MD15 Import License from the Central Licensing Authority.

The process includes:

• Document preparation including existing manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE marking (if applicable), Device and Plant Master Files, and wholesale license.
• Submission of application on the CDSCO MD Online Portal.
• Resolution of departmental queries.
• Grant of the MD15 Import License.

Detailed instructions can be found in our Import License Guide.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 4 weeks depending on lab workload
• Application Review & Audit: 1 to 1.5 months
• Query Resolution: 2 to 4 weeks
• Total Duration for MD5 License: Approximately 3 to 4 months from test license application to grant

Manufacturers should plan timelines accordingly, especially considering the audit scheduling and testing duration.

Government Fees and Costs

• Application Fee: INR 5,000 per MD5 license application
• Product Fee: INR 500 per product

Additional costs may include:

• Testing laboratory fees (variable, typically INR 50,000 to INR 1,00,000 depending on test scope)
• Notified body audit fees (range INR 1,00,000 to INR 2,00,000 depending on scope and location)
• Internal costs for document preparation and consultancy

Budgeting for these expenses early helps avoid delays.

Common Challenges and Solutions

Challenge: Delays in product testing due to lab backlogs.

Solution: Schedule testing early and consider multiple CDSCO-approved laboratories to minimize wait times.

Challenge: Incomplete or inconsistent documentation causing audit failures.

Solution: Utilize comprehensive checklists and conduct internal audits before submission. Engaging expert consultants can ensure documentation accuracy.

Challenge: Queries from CDSCO or notified bodies prolonging the process.

Solution: Respond promptly with detailed and evidence-backed clarifications.

Challenge: Understanding evolving regulatory updates.

Solution: Regularly monitor official CDSCO notifications and subscribe to regulatory updates.

Expert Consultation and Support

With over 500 successful CDSCO licenses facilitated, our team offers end-to-end support:

• Gap analysis of existing documentation
• Preparation of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• Application filing and query management
• Training on regulatory compliance and QMS implementation

Our proactive approach reduces approval time and mitigates compliance risks.

Getting Started with Your CDSCO License Application for Catheter-Balloon Inflators

To initiate your licensing journey:

1. Visit the CDSCO MD Online Portal and register your organization.
2. Prepare the necessary documentation guided by our Device Master File and Plant Master File resources.
3. Apply for the Test License (Form MD13) to begin sample production.
4. Coordinate product testing at approved laboratories.
5. Compile test reports and supporting documents.
6. Submit your MD5 license application (Form MD3) through the portal.
7. Schedule and prepare for the notified body audit.
8. Address any queries promptly.

Leveraging our expertise can streamline these steps and ensure your catheter-balloon inflator reaches the Indian market efficiently and compliantly.

For personalized assistance, reach out to our regulatory experts and take the first step towards successful CDSCO licensing today.