CDSCO License for Intrauterine haemostatic balloon catheter

Introduction: Understanding the Intrauterine Haemostatic Balloon Catheter and Its Regulatory Significance

The intrauterine haemostatic balloon catheter is a critical obstetrical and gynecological medical device designed to control postpartum bleeding by applying pressure within the uterus. This sterile, flexible tube with an inflatable balloon, distended with sterile water or medical air, plays a vital role in maternal healthcare. Given its direct impact on patient safety and clinical efficacy, regulatory compliance with the Central Drugs Standard Control Organisation (CDSCO) is mandatory before marketing this device in India.

As experts with over 25 years of experience and having assisted 500+ companies in navigating CDSCO licensing, we understand the nuances and complexities involved. This guide provides detailed insights into the CDSCO regulatory framework for Class B devices like the intrauterine haemostatic balloon catheter, practical steps for obtaining manufacturing and import licenses, timelines, costs, and common challenges.

CDSCO Regulatory Framework for Intrauterine Haemostatic Balloon Catheters

This device falls under the obstetrical and gynecological category and is notified under File No. 29/Misc./03/2020-DC (181), dated 03.06.2022. As a Class B medical device, it is subject to moderate risk classification, requiring compliance with specific regulatory pathways to ensure safety, quality, and performance.

The CDSCO governs licensing through a structured framework, mandating manufacturers and importers to obtain appropriate licenses before production or sale in India. The key regulatory instruments for Class B devices include the MD5 manufacturing license and MD15 import license.

Risk Classification and License Requirements for Class B Devices

Class B medical devices are considered low to moderate risk. According to CDSCO rules, these devices require:

• Manufacturing License: MD5 License (Application Form MD3) issued by the State Licensing Authority.
• Import License: MD15 License (Application Form MD14) issued by the Central Licensing Authority.

This two-tier licensing ensures thorough evaluation of manufacturing processes, product quality, and compliance with Indian standards.

For a detailed understanding of medical device classification, refer to our comprehensive Medical Device Classification guide.

Manufacturing License Process (MD5) for Intrauterine Haemostatic Balloon Catheter

Obtaining the MD5 manufacturing license for Class B devices involves several essential steps:

1. Test License Acquisition: Begin by applying for a Test License on Form MD13. This step permits limited manufacture for testing and evaluation.
2. Product Testing: Get the device tested through government-approved laboratories to ensure compliance with safety and performance standards.
3. Document Preparation: Compile necessary documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. Application Submission: Submit the application on Form MD3 via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body conducts a mandatory audit of manufacturing premises and QMS. You can check the list of notified bodies authorized for this audit.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. License Grant: Upon successful review, the MD5 license is granted, allowing full-scale manufacturing.

For an in-depth walkthrough, see our MD5 Manufacturing License Guide.

Manufacturing License Documents Required for Class B Devices

Preparing a comprehensive and error-free dossier is key to timely approval. The following documents are essential:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed design and specifications. Our Device Master File guide provides practical insights.
• Plant Master File (PMF): Manufacturing processes and facility details. See our Plant Master File guide for expert advice.
• Essential Principles Checklist confirming compliance with Indian and international standards
• Risk Management File aligned with ISO 14971 principles
• Test Reports from approved laboratories (refer to the Testing Laboratories list)
• Product Labels and Instructions for Use (IFU)
• Quality Management System documents – typically ISO 13485:2016 certification

Import License Process (MD15) for Intrauterine Haemostatic Balloon Catheter

If you plan to import the intrauterine haemostatic balloon catheter into India, the MD15 import license is mandatory. This process is overseen by the Central Licensing Authority and generally takes longer than manufacturing licenses due to additional scrutiny.

Key steps include:

1. Document Compilation: Prepare all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, Device Master File, Plant Master File, and wholesale license.
2. Application Submission: Submit the application on Form MD14 through the CDSCO MD Online Portal.
3. Query Resolution: Address any queries raised by CDSCO promptly.
4. License Issuance: Upon satisfactory review, the MD15 license is granted.

For detailed guidance, consult our Import License Guide.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3 to 4 months total. This includes 1.5 to 2 months for the test license (MD13), product testing, audit, and final license issuance.
• MD15 Import License: Approximately 5 to 6 months from application submission to license grant.

Maintaining proactive communication and prompt query resolution can significantly reduce delays.

Government Fees and Costs

• MD5 License Fees: Rs 5000 per application plus Rs 500 per product.
• MD15 Import License Fees: For Class B devices, $2000 per site plus$1000 per product.

Budgeting for these fees upfront helps avoid unexpected financial bottlenecks.

Common Challenges and Solutions

• Delayed Testing Reports: To avoid bottlenecks, engage with government-approved testing labs early and confirm their turnaround times.
• Incomplete Documentation: Use detailed checklists and expert templates to ensure all documents, especially DMF and PMF, meet CDSCO standards.
• Audit Non-compliance: Conduct internal audits and gap assessments before notified body visits to ensure readiness.
• Query Resolution Delays: Assign dedicated personnel to respond promptly and comprehensively to CDSCO queries.

Our extensive experience enables us to anticipate and mitigate these challenges effectively.

Expert Consultation and Support

Navigating CDSCO regulations for devices like the intrauterine haemostatic balloon catheter requires expert knowledge and meticulous preparation. We offer tailored consultation services encompassing:

• Regulatory strategy and classification
• Comprehensive document preparation and review
• Audit readiness and support
• Liaison with CDSCO and notified bodies
• End-to-end application management

Partnering with seasoned consultants can streamline your compliance journey and reduce time-to-market.

Getting Started with Your CDSCO License Application

To initiate your licensing process for the intrauterine haemostatic balloon catheter:

1. Assess Your Product Classification: Confirm Class B status using our Medical Device Classification resource.
2. Prepare Test License Application: Apply for the MD13 test license through the CDSCO MD Online Portal.
3. Engage Testing Laboratories: Schedule testing with notified government-approved labs early.
4. Compile Essential Documents: Utilize our Device Master File and Plant Master File guides for comprehensive document preparation.
5. Plan for Audit: Identify a suitable notified body from the official list and prepare your facility for audit.
6. Submit Application: File your application via the CDSCO MD Online Portal and maintain organized records for quick query resolution.

Our team is ready to assist you at every stage, ensuring a smooth and successful licensing experience. Contact us today to leverage our expertise and accelerate your market entry.

By following this structured approach, manufacturers and importers of intrauterine haemostatic balloon catheters can confidently navigate the CDSCO regulatory landscape, ensuring compliance, patient safety, and commercial success in the Indian medical device market.