CDSCO License for High-flow blood transfusion pump
Medical Device Information
Intended Use
A device to be used for rapidly infusing blood or other fluids during surgical procedures involving major bleeding, or for burns or injuries.
Comprehensive Guide to CDSCO Licensing for High-flow Blood Transfusion Pumps (Class C Medical Device)
As a trusted regulatory consultancy with over 25 years of experience and having successfully guided 500+ companies through India's medical device regulatory landscape, we understand the critical importance of obtaining the right CDSCO license for your high-flow blood transfusion pump. This Class C device, intended for rapid infusion of blood or fluids during major surgeries or trauma care, demands meticulous compliance to ensure patient safety and market access.
Understanding Your Device and Regulatory Importance
The high-flow blood transfusion pump is an essential operation theatre device designed to deliver blood or fluids rapidly during critical procedures involving major bleeding, burns, or injuries. Given its life-saving role and inherent risks, the device is classified as Class C under the CDSCO medical device classification system, reflecting a moderate to high risk level.
Regulatory compliance with CDSCO not only ensures your device meets India's quality and safety standards but also builds trust with healthcare providers and patients. Non-compliance can lead to market entry delays, legal penalties, and reputational damage.
CDSCO Regulatory Framework for High-flow Blood Transfusion Pumps
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. For Class C devices like your high-flow blood transfusion pump, the regulatory pathway requires obtaining an MD9 manufacturing license, issued by the Central Licensing Authority.
The relevant official notification governing this device is File No. 29/Misc/03/2020-DC (199), dated 13.09.2021, which recognizes this device category under operation theatre equipment requiring stringent regulatory oversight.
Risk Classification and License Requirements
- Risk Class: C (Moderate to High Risk)
- License Required: MD9 Manufacturing License (Application Form MD7)
- Licensing Authority: Central Licensing Authority, CDSCO
Class C devices must undergo rigorous scrutiny including test license acquisition, testing in government-approved labs, document evaluation, and a mandatory audit.
For detailed classification criteria, you can refer to the Medical Device Classification guide.
Manufacturing License Process for High-flow Blood Transfusion Pumps (MD9)
Our proven process for obtaining the MD9 license includes the following steps:
Obtain Test License (Form MD13): Initiate your application for a test license allowing you to manufacture and test your device prototype. This step usually takes 1.5 to 2 months.
Product Testing: Once the test license is granted, your blood transfusion pump must be tested by CDSCO-approved testing laboratories to verify compliance with applicable standards. Refer to the list of testing laboratories for options.
Document Compilation: Prepare a comprehensive dossier including your Device Master File, Plant Master File, Quality Management System documents, and risk management files.
Apply for MD9 License (Form MD7): Submit your manufacturing license application via the CDSCO MD Online Portal.
CDSCO Inspection: Following document scrutiny, CDSCO inspectors will audit your manufacturing facility.
Query Resolution: Promptly address any queries or observations raised during inspection or document review.
License Grant: Upon satisfactory completion of all steps, the MD9 manufacturing license will be issued.
For an in-depth walkthrough, consult our MD9 License Guide.
Manufacturing License Documents Required
To ensure a smooth approval process, prepare the following key documents:
- Company Constitution and Incorporation certificates
- Proof of ownership or lease of manufacturing premises
- Technical staff qualifications and experience
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and intended use – see our Device Master File Guide
- Plant Master File (PMF) outlining manufacturing processes – refer to our Plant Master File Guide
- Essential Principles Checklist confirming compliance with safety and performance requirements
- Risk Management File evidencing hazard analysis and mitigation – for more details see Risk Management
- Product test reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) in English
- Quality Management System documentation, preferably ISO 13485:2016 certification
Import License Process (MD15) for High-flow Blood Transfusion Pumps
If you are an importer, the MD15 license is mandatory before bringing this Class C device into India. The process includes:
- Document preparation including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE certificate, DMF, PMF, wholesale license, and company constitution
- Application submission on the CDSCO MD Online Portal
- Queries resolution
- Grant of MD15 License (Form MD15)
The import license timeline is approximately 5-6 months.
For detailed guidance, visit our Import License Guide.
Timeline and Processing Duration
| Step | Duration Estimate |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 1 month (parallel) |
| Application Review & Audit | 1.5 to 2 months |
| Total Time for MD9 License | Approximately 4 to 5 months |
Manufacturers should plan for approximately 4-5 months from start to finish, assuming timely responses to queries and inspection readiness.
Government Fees and Costs
- Test License (MD13): Rs 10,000 approx
- MD9 Manufacturing License Application Fee: Rs 50,000 per application
- Product Fee: Rs 1,000 per product
Additional costs may include testing charges at government-approved laboratories (variable based on tests required), notified body audit fees, and consultancy fees if availed.
Common Challenges and Solutions
- Delayed Test Reports: Testing labs often have backlogs; early booking is crucial.
- Incomplete Documentation: Use checklists and expert consultation to avoid missing documents.
- Audit Non-compliance: Conduct internal mock audits before CDSCO inspection.
- Query Resolution Delays: Assign a dedicated team to respond promptly.
We have helped over 500 companies navigate these challenges efficiently using our structured approach and industry insights.
Expert Consultation and Support
Given the complexity and stakes involved, partnering with experienced regulatory consultants can significantly smoothen your CDSCO licensing journey. We provide end-to-end support from dossier preparation, liaising with testing labs, scheduling audits, to post-approval compliance.
Getting Started with Your CDSCO License Application
- Evaluate your Device Classification: Confirm your device is Class C; refer to Medical Device Classification.
- Prepare Essential Documentation: Start assembling your Device Master File, Plant Master File, and Quality Management System documents.
- Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
- Schedule Product Testing: Coordinate with CDSCO-approved labs early to avoid delays.
- Plan Audit Readiness: Review manufacturing processes, technical staff credentials, and compliance records.
- File MD9 Application: After successful testing, submit your application on the portal.
Our team is ready to assist you throughout this process, ensuring your high-flow blood transfusion pump meets all regulatory requirements for a successful market launch in India.
For personalized guidance, feel free to reach out and leverage our decades of expertise in CDSCO licensing.
