CDSCO License for Blood transfusion set, exchange
Medical Device Information
Intended Use
A sterile, intravascular administration set used to remove a diseased infant's blood and replace it with fresh donor blood or plasma. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.
Comprehensive Guide to CDSCO Licensing for Blood Transfusion Set, Exchange (Class B)
Blood transfusion sets, especially exchange types used in pediatrics and neonatology, are critical medical devices designed to safely remove and replace a diseased infant’s blood. Given their sterile, single-use nature and vital application, these devices fall under Class B risk classification in India. This classification mandates strict adherence to regulatory requirements enforced by the Central Drugs Standard Control Organization (CDSCO). With over 25 years of expertise assisting 500+ companies in securing CDSCO licenses, we provide you with a detailed, step-by-step guide to obtaining your manufacturing or import license for this device.
Understanding the CDSCO Regulatory Framework for Blood Transfusion Sets
The CDSCO governs medical device regulation in India under the Medical Devices Rules, 2017. Blood transfusion sets, exchange are notified devices under File No. 29/MiscJ03/2020-DC (150), dated 23.08.2021, which means they must comply with specific licensing protocols before marketing.
Manufacturers of Class B devices must obtain an MD5 manufacturing license from the State Licensing Authority. Importers require an MD15 import license from the Central Licensing Authority. Compliance ensures device safety, performance, and traceability in the Indian market.
Risk Classification and License Requirements for Blood Transfusion Set, Exchange
Blood transfusion sets are classified as Class B devices due to their moderate risk and invasive use in vulnerable populations like neonates. This classification determines the licensing pathway:
- Manufacturing License: MD5 license (Application Form MD3) granted by the State Authority
- Import License: MD15 license (Application Form MD14) granted by the Central Authority
Class B devices require a test license (MD13) initially for product testing in CDSCO-approved labs.
Manufacturing License Process (MD5) for Blood Transfusion Set, Exchange
The MD5 license process for Class B devices is comprehensive and typically spans 3-4 months. Here is the detailed workflow:
Test License Application (Form MD13): Obtain a test license to allow product testing in CDSCO-recognized labs. This phase takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory testing at government-approved laboratories to verify compliance with notified standards. Refer to the list of testing labs for suitable facilities.
Document Preparation: Compile all technical, quality, and regulatory documents.
License Application (Form MD3): Submit the MD5 manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: The notified body conducts a detailed audit of your manufacturing premises and quality systems. Check the notified bodies list for approved auditors.
Queries Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant (Form MD5): Upon satisfactory audit and documentation review, the State Licensing Authority issues the manufacturing license.
For a full guide on the MD5 license, please refer to our MD5 License Guide.
Manufacturing License Documents Required for Blood Transfusion Set, Exchange
Accurate documentation is critical to avoid delays. Here is the comprehensive list:
- Company Constitution (e.g., Incorporation Certificate, Partnership Deed)
- Proof of Ownership or Lease of Premises
- Details and qualifications of Technical Staff
- Fire NOC and Pollution Control Board Clearance
- Device Master File (DMF) detailing design, manufacturing process, and specifications (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing facility and quality controls (Plant Master File Guide)
- Essential Principles Checklist ensuring compliance with Indian standards
- Risk Management File highlighting hazard analysis and mitigation strategies (Risk Management)
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485 certified
Import License Process (MD15) for Blood Transfusion Set, Exchange
Importers of blood transfusion sets must comply with the following steps, with a total timeline of 5-6 months:
Document Preparation: Gather manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
Application Submission: File the import license application (Form MD14) via the CDSCO MD Online Portal.
Query Resolution: Respond to any queries raised by CDSCO promptly.
License Issuance: Upon successful review, the Central Licensing Authority grants the MD15 import license.
Refer to our detailed Import License Guide for more information.
Import License Documents Required
The following documents are essential:
- Valid Manufacturing License from the exporting country
- Free Sale Certificate (FSC) confirming market authorization
- ISO 13485:2016 Certificate
- CE Certificate or equivalent regulatory approval
- Device Master File and Plant Master File
- Wholesale License for distribution
- Company Constitution
- Proof of manufacturing site compliance
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Manufacturing (MD5) | 3 to 4 months total |
| Import (MD15) | 5 to 6 months |
The MD5 license includes test license, product testing, audit, and final approval. Delays often arise due to incomplete documentation or audit non-conformities.
Government Fees and Costs
- MD5 License: Rs. 5,000 per application + Rs. 500 per product
- MD15 Import License: Fees depend on risk class; for Class B devices, expect approximately 1,000 per product
Budgeting for additional costs such as product testing, notified body audits, and consultancy fees is prudent.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all files, especially Device Master File and Risk Management File, are thorough and up to date.
- Audit Non-Conformities: Prepare your facility in advance by conducting internal audits and training staff.
- Testing Delays: Schedule tests early and choose labs with shorter turnaround times from the CDSCO-approved list.
- Regulatory Updates: Stay informed on regulatory changes affecting pediatric and neonatology devices.
Our extensive experience has enabled us to help clients navigate these hurdles efficiently.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for specialized devices like blood transfusion sets. We offer expert consultation to:
- Analyze your product’s classification and regulatory requirements
- Prepare and review all necessary documentation
- Liaise with CDSCO and notified bodies
- Coordinate product testing and audits
- Provide end-to-end application management
Our track record of 500+ successful CDSCO licenses demonstrates our commitment to simplifying your regulatory journey.
Getting Started with Your CDSCO License Application
To initiate the process for your Blood Transfusion Set, Exchange manufacturing license:
Register on the CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal.
Gather Documentation: Start compiling your Device Master File, Plant Master File, and Risk Management documentation.
Apply for Test License (MD13): Submit your application early to avoid delays.
Plan Product Testing: Engage with approved labs and schedule testing promptly.
Prepare for Audit: Conduct internal quality system audits and train staff.
Submit Manufacturing License Application (MD3): After successful testing, apply for the MD5 license.
Engage Expert Support: Consider partnering with experienced regulatory consultants to streamline submissions and respond to authority queries.
By following these actionable steps and leveraging our seasoned guidance, you can efficiently obtain your CDSCO license and confidently enter the Indian market with your blood transfusion set, exchange.
For personalized assistance or to learn more about our regulatory services, reach out to our team—your trusted partner in medical device compliance.
