CDSCO License for Blood storage refrigerator

Comprehensive Guide to CDSCO Licensing for Blood Storage Refrigerators (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we understand the critical importance of regulatory compliance for medical devices such as blood storage refrigerators. These devices play a vital role in healthcare by preserving blood and blood products at controlled cold or freezing temperatures, ensuring their safety and efficacy. Securing the appropriate CDSCO license is mandatory before manufacturing or marketing these devices in India.

CDSCO Regulatory Framework for Blood Storage Refrigerators

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Blood storage refrigerators fall under Class B (Low Moderate Risk) devices, listed under the category of General Hospital or Orthopaedic Instruments. The relevant notification governing this device is 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022.

This classification makes the device subject to the MD5 manufacturing license process, which involves state-level regulatory authorities.

Risk Classification and License Requirements

Blood storage refrigerators are classified as Class B devices, indicating a low moderate risk to patients and users. This classification mandates obtaining an MD5 license (using Application Form MD3) granted by the State Licensing Authority.

The MD5 license process includes:

• Obtaining a Test License (Form MD13) for initial product testing
• Product testing at CDSCO-recognized labs
• Audit by a notified body
• Submission of detailed technical and quality documentation

You can reference the full medical device classification details for further clarity.

Manufacturing License Process (MD5) for Blood Storage Refrigerators

The MD5 license process typically takes 3-4 months from start to finish. Below is the sequential roadmap:

1. Apply for Test License (MD13) – Takes approximately 1.5 to 2 months.
2. Conduct Product Testing – Testing must be done at a CDSCO-approved testing laboratory. Refer to the list of testing laboratories for recognized facilities.
3. Document Preparation – Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and others.
4. Apply for MD5 License (Form MD3) – Submit the application via the CDSCO MD Online Portal.
5. Notified Body Audit – An audit by a notified body is mandatory. Check the list of notified bodies to select an authorized auditor.
6. Resolve Queries – Respond promptly to any queries from CDSCO or the notified body.
7. Grant of MD5 License – Upon successful audit and document verification, the license is issued.

Manufacturing License Documents Required

To ensure your application is complete and compliant, prepare the following documents:

• Company Constitution (Incorporation certificate, MOA/AOA)
• Proof of Ownership or Lease Agreement for manufacturing premises
• Technical Staff Qualifications and Experience
• Fire and Pollution NOCs from local authorities
• Device Master File (DMF) detailing design, specifications, and manufacturing process. Our Device Master File guide can help you prepare this.
• Plant Master File (PMF) describing premises and quality systems (see our Plant Master File guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File addressing identified hazards and mitigations
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, such as ISO 13485:2016 certification

Import License Process (MD15) for Blood Storage Refrigerators

For companies importing blood storage refrigerators into India, an MD15 import license is required from the Central Licensing Authority. The process:

• Requires comprehensive documentation including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificates, Device and Plant Master Files, and wholesale license.
• Takes approximately 5-6 months to complete.
• Applied via the CDSCO MD Online Portal.

You can read our detailed Import License guide for step-by-step assistance.

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): Approximately Rs. 5000 (varies by state)
• MD5 License Application Fee: Rs. 5000 per application
• Product-wise Fee: Rs. 500 per product
• Testing and Audit Costs: Variable depending on notified body and lab fees; typically Rs. 50,000 – Rs. 1,00,000

Budgeting for testing and audit costs early helps avoid delays.

Common Challenges and Solutions

Challenge: Delay in test report generation from approved labs

Solution: Engage labs early and ensure clear communication of test protocols. Use the list of testing laboratories for selecting accredited labs.

Challenge: Incomplete or inconsistent documentation

Solution: Use checklists for all required documents, and leverage expert consultation for document review before submission.

Challenge: Audit non-compliance findings

Solution: Conduct internal audits before notified body visits and maintain robust QMS practices.

Challenge: Query resolution delays

Solution: Assign dedicated regulatory personnel to respond swiftly and accurately to CDSCO or audit queries.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for devices like blood storage refrigerators where compliance is critical for public health. Our consultancy offers:

• Tailored guidance on documentation and process flow
• Assistance with application submission on the CDSCO MD Online Portal
• Coordination with notified bodies and testing labs
• Pre-audit internal assessments
• End-to-end project management to meet timelines

Our track record of over 500 successful CDSCO licenses stands as a testament to our expertise.

Getting Started with Your CDSCO License Application

1. Assess your device classification and confirm it aligns with Class B under current CDSCO notifications.
2. Prepare your technical documentation, starting with the Device Master File and Plant Master File.
3. Apply for the Test License (MD13) through the CDSCO MD Online Portal.
4. Select and coordinate with a CDSCO-recognized testing laboratory for sample testing.
5. Engage a notified body early for scheduling your audit.
6. Compile and submit your MD5 license application (Form MD3) once testing is complete.
7. Maintain proactive communication with CDSCO authorities to resolve queries promptly.

Starting early and following a structured approach reduces approval timelines and helps you enter the Indian market with confidence.

For personalized support and to ensure a seamless licensing journey, reach out to our regulatory experts who specialize in medical device compliance in India.