CDSCO License for Pressure infusor for an I.V. bag.

Introduction to Pressure Infusor for I.V. Bag and Its Regulatory Importance

Pressure infusors for I.V. bags are vital medical devices used in hospitals to safely and effectively increase pressure on intravenous fluid bags, ensuring smooth fluid infusion. As a Class B medical device under the CDSCO classification, these devices require stringent regulatory compliance to guarantee patient safety and product efficacy. Navigating India’s regulatory landscape for such devices demands a detailed understanding of the Central Drugs Standard Control Organisation (CDSCO) framework, including licensing, audits, testing, and documentation.

With over 25 years of experience assisting 500+ companies, we understand the critical nuances of securing your CDSCO license for Pressure Infusors, enabling you to legally manufacture and market your device across India.

CDSCO Regulatory Framework for Pressure Infusors (Class B Medical Devices)

Pressure infusors are categorized under General Hospital or Orthopaedic Instruments as per Notification 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022. Being a Class B device, the licensing authority falls under the state-level CDSCO jurisdiction, requiring an MD5 manufacturing license. The regulatory pathway involves obtaining a test license (MD13), conducting product testing in government-approved labs, followed by an audit from a notified body, and finally, applying for the manufacturing license.

This stepwise regulatory process ensures compliance with Indian medical device standards, quality management systems, and safety principles.

Risk Classification and License Requirements for Pressure Infusors

Pressure infusors are classified as Class B devices, which are considered low to moderate risk. According to the CDSCO classification:

• License Type: MD5 Manufacturing License
• Application Form: MD3
• Licensing Authority: State Licensing Authority
• Process Duration: Approximately 3 to 4 months end-to-end
• Fees: Rs 5000 application fee + Rs 500 per product

Understanding this classification is essential to select the correct licensing form and comply with audit and testing requirements.

Manufacturing License Process (MD5) for Pressure Infusors

1. Test License Application (Form MD13): The first step is to apply for a test license, which allows limited manufacture for testing purposes. This takes about 1.5 to 2 months.
2. Product Testing: After receiving the test license, the pressure infusor must undergo performance and safety testing at government-approved laboratories. Refer to the CDSCO list of Testing Laboratories for authorized centers.
3. Documentation Preparation: Simultaneously, prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. Application for MD5 License: Submit the manufacturing license application (Form MD3) through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body conducts a thorough audit of your manufacturing facility and quality management systems. Check the list of notified bodies for audit assignments.
6. Query Resolution: Address any observations or queries raised by the licensing authority or notified body promptly.
7. Grant of License: On successful completion of all steps, the MD5 license is granted.

Manufacturing License Documents Required for Pressure Infusors

To ensure a smooth application process, prepare the following documents meticulously:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing technical specifications, design, manufacturing process, and safety data (Device Master File Guide)
• Plant Master File (PMF) outlining manufacturing environment, equipment, and quality controls (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with Indian medical device regulations
• Risk Management File demonstrating hazard analysis and mitigation strategies (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Ensuring all these documents are accurate and up to date significantly reduces review time and avoids common delays.

Import License Process (MD15) for Pressure Infusors

For importers intending to bring pressure infusors into India, the MD15 license is mandatory, issued by the Central Licensing Authority. The process includes:

• Preparation of import-specific documentation such as Free Sale Certificate, ISO 13485:2016 certification, CE Certificate if applicable, and manufacturing license from the country of origin.
• Submission of Form MD14 through the CDSCO MD Online Portal.
• Resolution of any queries during the evaluation.
• License grant within 5 to 6 months.

Note: Since pressure infusors are Class B, the applicable fees are moderate compared to higher-risk devices.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Proper documentation ensures expedited license approval without requests for additional information.

Timeline and Processing Duration

Understanding this timeline helps manufacturers plan production and market entry effectively.

Government Fees and Costs for MD5 License

• Application Fee: Rs 5000 (one-time)
• Product-wise Fee: Rs 500 per product

Additional costs include:

• Testing fees charged by government-approved labs
• Notified body audit fees
• Consultancy or document preparation costs (if outsourced)

Budgeting accurately for these expenses avoids surprises and ensures smooth progression.

Common Challenges and Solutions

• Delayed Test Reports: Engage with authorized testing labs early and confirm testing scope to avoid bottlenecks.
• Incomplete Documentation: Use detailed checklists and expert reviews to ensure document completeness.
• Audit Non-compliance: Pre-audit your facility with professionals familiar with CDSCO requirements.
• Query Response Delays: Assign dedicated personnel for timely communication with CDSCO officials.

Our experience shows proactive planning and expert guidance drastically reduce these common pain points.

Expert Consultation and Support

With over 25 years of regulatory expertise and over 500 successful CDSCO license applications, our team provides:

• End-to-end assistance in document preparation
• Coordination with notified bodies and testing labs
• Pre-audit readiness assessments
• Strategic advice on regulatory pathways

Our proven track record in medical device regulatory consulting ensures your pressure infusor license application is handled with precision and efficiency.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal.
2. Initiate Test License Application: Apply for the MD13 test license to begin the manufacturing and testing process.
3. Engage with Testing Laboratories: Schedule product testing with CDSCO-approved labs early to align with your production timelines.
4. Prepare Required Documentation: Use expert guides such as our Device Master File guide and Plant Master File guide to compile your dossiers.
5. Plan for Notified Body Audit: Identify and connect with notified bodies from the official list for audit scheduling.
6. Submit MD5 License Application: Once testing and audits are complete, apply formally for the manufacturing license.

Starting early with a clear roadmap ensures your pressure infusor reaches the Indian market without regulatory roadblocks. For personalized assistance, reach out to our expert team to fast-track your CDSCO licensing process.