CDSCO License for Cardiopulmonary bypass temperature controller
Medical Device Information
Intended Use
A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.
Comprehensive Guide to CDSCO Licensing for Cardiopulmonary Bypass Temperature Controller (Class B Medical Device)
Cardiopulmonary bypass temperature controllers play a critical role in cardiovascular surgeries by regulating the temperature of fluids circulating through heat exchangers. Ensuring precise temperature control is vital to patient safety and procedural success. Given its specialized function and moderate risk classification (Class B), obtaining the correct CDSCO license is mandatory for manufacturers and importers aiming to enter the Indian market.
At our consultancy, with over 25 years of experience and having supported more than 500 companies, we provide you with clear, step-by-step guidance to navigate the CDSCO regulatory framework efficiently.
CDSCO Regulatory Framework for Cardiopulmonary Bypass Temperature Controllers
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules 2017. Cardiopulmonary bypass temperature controllers fall under the cardiovascular category as per the notified classification (Notification 29/Misc./03/2020-DC (159), dated 26.7.2021).
As a Class B device, the regulation mandates obtaining a manufacturing license (MD5) granted by the State Licensing Authority. This ensures compliance with safety, performance, and quality standards.
Risk Classification and License Requirements
- Risk Class: B (Low to moderate risk)
- License Required: MD5 Manufacturing License
- Governing Authority: State Licensing Authority
- Application Form: MD3
Class B devices like the cardiopulmonary bypass temperature controller require a rigorous but streamlined regulatory process, balancing safety and market access.
Manufacturing License Process (MD5)
The MD5 license process involves several key steps:
- Test License Application (Form MD13): Before full manufacturing license application, a test license is required to produce the device for testing purposes. This step typically takes 1.5 to 2 months.
- Product Testing: Testing must be conducted at CDSCO-approved laboratories for parameters such as electrical safety, biocompatibility, and functional performance. Refer to the Testing Laboratories approved by CDSCO.
- Document Preparation: Compilation of technical and quality documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
- License Application Submission (Form MD3): Apply through the CDSCO MD Online Portal.
- Audit by Notified Body: An audit is conducted by a CDSCO-notified body to verify manufacturing facility compliance. Find a suitable auditor from the list of notified bodies.
- Resolution of Queries: Address any observations or clarifications raised by the authority or notified body.
- Grant of License (Form MD5): Upon successful review and audit, the manufacturing license is granted.
For a detailed walkthrough, our MD5 License Guide offers practical insights.
Manufacturing License Documents Required
For your cardiopulmonary bypass temperature controller, the following documentation is essential:
- Company Constitution/Registration Certificate
- Proof of Ownership or Lease of Premises
- Details and qualifications of Technical Staff
- Fire Safety NOC
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing process. Learn more in our Device Master File guide.
- Plant Master File describing the manufacturing facility, equipment, and quality systems. See our Plant Master File guide.
- Essential Principles Checklist confirming compliance with regulatory requirements
- Risk Management File documenting risk analysis and mitigation strategies. Our Risk Management resource helps you get started.
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485 compliant
Import License Process (MD15) for Cardiopulmonary Bypass Temperature Controllers
If you are importing this device into India, an MD15 import license is mandatory, granted by the Central Licensing Authority. The process generally takes 5 to 6 months and requires comprehensive documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE marking (if applicable), and more.
Refer to our Import License Guide for a detailed step-by-step process.
Import License Documents Required
- Manufacturing License of the device in the country of origin
- Free Sale Certificate
- ISO 13485:2016 certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License in India
- Company Constitution
Fees vary by class and volume, so budgeting carefully is essential.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 2 to 3 weeks |
| License Application Review | 4 to 6 weeks |
| Audit by Notified Body | 3 to 4 weeks |
| Query Resolution | 2 to 4 weeks |
| Total Time for MD5 License | Approximately 3 to 4 months |
Government Fees and Costs
- Test License Fee (MD13): Typically Rs 5,000 per application
- MD5 License Fee: Rs 5,000 per application + Rs 500 per product
Additional costs include fees for product testing, audit charges by notified bodies, and consultancy fees if applicable.
Common Challenges and Solutions
Challenge 1: Incomplete Documentation
- Solution: Use detailed checklists and templates for Device Master Files and Plant Master Files to ensure completeness.
Challenge 2: Delayed Product Testing
- Solution: Engage CDSCO-approved laboratories early and pre-schedule testing to avoid bottlenecks.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal pre-audits and gap assessments; train your technical team on regulatory expectations.
Challenge 4: Delays in Query Resolution
- Solution: Prepare clear, evidence-backed responses; assign dedicated personnel for communication with CDSCO.
Expert Consultation and Support
Navigating the CDSCO licensing process can be complex, especially for Class B devices like the cardiopulmonary bypass temperature controller. Our team offers tailored consultancy services, including document preparation, liaison with notified bodies, and audit readiness support.
We have successfully facilitated licensing for over 500 medical device companies, ensuring expedited approval and regulatory compliance.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm that your cardiopulmonary bypass temperature controller is Class B.
- Prepare Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File.
- Apply for Test License (MD13): Submit this via the CDSCO MD Online Portal to commence the regulatory process.
- Schedule Product Testing: Select and coordinate with a CDSCO-approved testing laboratory.
- Engage a Notified Body: Identify and book an audit with a notified body from the official list.
- Prepare for Audit and License Application: Use our expert guides and templates to ensure a smooth audit and application submission.
By following these practical steps and leveraging expert support, you can efficiently secure your MD5 license and bring your cardiopulmonary bypass temperature controller to the Indian market.
For personalized assistance, please contact our regulatory consultancy team to schedule a comprehensive license readiness assessment.
