CDSCO License for Intravascular administration set, automated air removal system.

Comprehensive Guide to CDSCO License for Intravascular Administration Set, Automated Air Removal System (Class B)

Entering the Indian medical device market requires a thorough understanding of the regulatory landscape. For manufacturers and importers of the Intravascular Administration Set, Automated Air Removal System, classified as a Class B device under CDSCO regulations, securing the appropriate license is both critical and mandatory. With over 25 years of experience helping 500+ companies successfully obtain CDSCO licenses, we provide detailed insights into the entire licensing process, timelines, costs, and documentation to streamline your journey.

Understanding Your Device and Its Regulatory Importance

Your device, designed to detect and automatically remove air from an intravascular administration set with minimal interruption to fluid flow, falls under the General Hospital or Orthopaedic Instruments category. As per the CDSCO notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, this device is classified as Class B, reflecting a low to moderate risk level. This classification directly impacts the licensing process and requirements.

CDSCO Regulatory Framework for Class B Medical Devices

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. Class B devices like your intravascular administration set require a State Licensing Authority issued MD5 Manufacturing License for local manufacturing, or an MD15 Import License if you are importing the device. The MDR emphasizes compliance with quality management systems, safety, and performance standards.

Risk Classification and License Requirements

Your device's Class B risk classification means:

• It is considered a low to moderate risk device.
• Requires an MD5 Manufacturing License (Form MD3) if produced in India.
• Requires a Test License (MD13) before the manufacturing license application.
• License applications are submitted to the State Licensing Authority.

For a detailed understanding of device classification and its implications, refer to our Medical Device Classification guide.

Manufacturing License Process for MD5 (Class B Devices)

The MD5 manufacturing license process involves several key steps:

1. Obtain Test License (Form MD13): This initial license allows limited manufacturing for product testing and validation. It usually takes 1.5 to 2 months.
2. Product Testing: Conduct testing at CDSCO-approved laboratories listed on the Testing Laboratories page. Testing includes safety, efficacy, and compliance with Indian standards.
3. Documentation Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Quality Management System (QMS), Risk Management File, and others as per regulatory norms.
4. Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit by a notified body is mandatory. Check the list of notified bodies to select an appropriate auditor.
6. Resolution of Queries: Address any queries raised by the CDSCO or the notified body promptly.
7. Grant of MD5 License (Form MD5): Once compliance is confirmed, the State Licensing Authority issues the license.

The entire process typically spans 3 to 4 months, including test license issuance, product testing, audit, and final approval.

Manufacturing License Documents Required

Preparing the right documentation is crucial. For your device, the following are mandatory:

• Company Constitution (e.g., MOA, AOA)
• Proof of ownership or lease of manufacturing premises
• Qualification and experience documents of technical staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design and manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) outlining facility infrastructure (Plant Master File Guide)
• Essential Principles Checklist confirming compliance
• Risk Management File demonstrating hazard identification and mitigation (Risk Management Guide)
• Product test reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Your Device

If you plan to import the intravascular administration set, the MD15 Import License process applies:

• No test license required.
• Submit application using Form MD14 via the CDSCO MD Online Portal.
• Provide documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
• The process is handled by the Central Licensing Authority and takes approximately 5 to 6 months.

Refer to our Import License Guide for detailed insights.

Import License Documents Required

• Valid Manufacturing License from the exporting country
• Free Sale Certificate
• ISO 13485:2016 Quality Management System certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License for distribution in India
• Company Constitution documents

Timeline and Processing Duration

Government Fees and Costs

For your Class B device under MD5 license:

• Application fee: Rs 5,000 per application
• Product fee: Rs 500 per product

Additional costs include product testing fees charged by accredited labs and notified body audit fees.

Common Challenges and Practical Solutions

1. Delays in Test License Approval:

• Submit complete and accurate documentation.
• Engage with CDSCO officials proactively.

2. Product Testing Failures:

• Select accredited labs with relevant experience.
• Conduct internal pre-testing to ensure compliance.

3. Audit Non-Compliance:

• Maintain robust QMS and documentation.
• Train staff on regulatory requirements.

4. Query Resolution Delays:

• Prepare prompt and detailed responses.
• Use regulatory consultants for clarity.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our team, with over two decades of experience and assisting 500+ companies, offers tailored support including document preparation, audit readiness, and liaison with regulatory authorities. Leveraging our expertise reduces timelines and enhances approval success.

Getting Started with Your CDSCO License Application

To initiate your license application for the Intravascular Administration Set, Automated Air Removal System, follow these actionable steps:

1. Assess Your Manufacturing or Import Plan: Define if you are manufacturing locally (MD5) or importing (MD15).
2. Register on the CDSCO MD Online Portal: Create an account to manage all submissions.
3. Gather Required Documents: Use the above lists to compile your comprehensive dossier.
4. Apply for Test License (if manufacturing): Submit Form MD13 and prepare for product testing.
5. Engage with Notified Bodies: Schedule audits early by referring to the Notified Bodies List.
6. Ensure Product Testing: Coordinate with accredited labs to complete testing on schedule.
7. Submit Manufacturing License Application (Form MD3): Post successful testing and audit.
8. Monitor Application Status: Respond to queries swiftly via the portal.

Embarking on this process with a strategic approach and expert guidance will position your medical device for successful market entry in India. For personalized assistance, please contact our regulatory consultants experienced in CDSCO licensing for Class B devices.

By following this comprehensive guide, manufacturers and importers can confidently navigate the CDSCO licensing journey for the Intravascular Administration Set, Automated Air Removal System, ensuring timely market access and regulatory compliance.