CDSCO License for Extracorporeal circuit waste bag
Medical Device Information
Intended Use
Intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., haemodialysis, haemofiltration, apheresis, adsorption treatment), including the collection and rinsing of ultrafiltrate fluid which may contain blood components.
Comprehensive Guide to CDSCO Licensing for Extracorporeal Circuit Waste Bag (Class B Device)
As seasoned regulatory consultants with over 25 years of experience and having successfully guided 500+ medical device manufacturers and importers, we understand the critical importance of securing the appropriate CDSCO license in India. The Extracorporeal Circuit Waste Bag—a Class B medical device used in nephrology and renal care—is pivotal in safely collecting waste fluids during procedures such as haemodialysis and apheresis. Compliance with CDSCO regulations is essential to ensure market access and patient safety.
CDSCO Regulatory Framework for Extracorporeal Circuit Waste Bag
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Since the Extracorporeal Circuit Waste Bag falls under the Class B (low-moderate risk) category, it requires a manufacturing license under the MD5 license framework, granted by the State Licensing Authority.
The device is notified under Notification Number 29/Misc./03/2020-DC (143) dated 13.09.2021, confirming its regulatory oversight and classification.
Risk Classification and License Requirements
Given its classification as a Class B device:
- License Type: MD5 Manufacturing License (Form MD3 for application, license granted on Form MD5)
- Regulatory Authority: State Licensing Authority
- Applicable Standards: Compliance with Essential Principles of Safety and Performance, ISO 13485:2016 QMS recommended
For detailed classification insights, manufacturers can refer to the Medical Device Classification guide.
Manufacturing License Process for Class B Devices (MD5 License)
The MD5 license process is multi-phased and typically spans 3 to 4 months from start to finish:
Test License Application (Form MD13): Apply for a test license, which takes 1.5 to 2 months to obtain. This license permits initial product manufacturing for testing purposes.
Testing: Conduct product testing at CDSCO-approved laboratories to validate safety and efficacy. A comprehensive list of Testing Laboratories is available.
Document Preparation: Compile all required documents, including the Device Master File and Plant Master File.
License Application Submission: Submit the MD5 license application (Form MD3) via the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body from the official Notified Bodies List.
Queries and Clarifications: Address any queries raised by the department or notified body.
Grant of License: Upon satisfactory compliance, the license is issued on Form MD5.
Manufacturing License Documents Required for Extracorporeal Circuit Waste Bag
A meticulous documentation package is crucial for a smooth application process. Required documents include:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design, specifications, and manufacturing processes. Our comprehensive Device Master File guide can assist.
- Plant Master File (PMF): Description of manufacturing facility and quality systems. Learn more via our Plant Master File guide.
- Essential Principles Checklist demonstrating compliance
- Risk Management File outlining hazard identification and mitigation as per Risk Management practices
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification
Import License Process for Extracorporeal Circuit Waste Bag
If importing the device into India, an MD15 Import License is required, governed by the Central Licensing Authority. This process takes approximately 5 to 6 months and includes:
- Preparation of import-specific documents, including Manufacturer’s License, Free Sale Certificate, CE Mark, ISO certification, and Device Master File
- Submission of application via the CDSCO MD Online Portal
- Resolution of any departmental queries
- Licensing granted on Form MD15
For detailed assistance, consult our Import License guide.
Import License Documents Required
Key documents include:
- 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 Drug License in India
- Company Constitution and Importer details
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Compilation | 2 – 3 weeks |
| Application Submission to License Grant (MD5) | 4 – 6 weeks |
Total estimated time: 3 to 4 months for manufacturing license.
Government Fees and Costs
- MD5 License Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product
Additional costs may include:
- Testing laboratory fees (varies based on test scope)
- Notified body audit charges
- Consultancy fees if engaging expert support
Budgeting accurately for these fees is critical to avoid delays.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all files, especially Device and Plant Master Files, are thorough and up-to-date. Use our detailed guides to avoid omissions.
- Testing Delays: Plan testing timelines well in advance and select CDSCO-approved labs to prevent bottlenecks.
- Audit Non-compliance: Conduct internal audits and mock inspections before notified body audits.
- Query Management: Respond promptly and comprehensively to department queries to expedite approval.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for manufacturers new to India’s regulatory environment. Our experienced team offers:
- End-to-end license application preparation
- Documentation drafting and review
- Coordinating testing and audits
- Handling queries and follow-ups
Our expertise has empowered over 500 companies to successfully enter the Indian medical device market.
Getting Started with Your CDSCO License Application
To initiate the licensing process for your Extracorporeal Circuit Waste Bag:
- Assess your current documentation against the checklist above.
- Apply for the Test License (MD13) via the CDSCO MD Online Portal.
- Schedule product testing at a CDSCO-approved laboratory.
- Prepare your Device and Plant Master Files using our comprehensive guides.
- Engage a notified body early for audit planning.
- Submit your MD5 application (Form MD3) once all prerequisites are met.
Starting early and adopting a structured approach will help you meet regulatory requirements within the standard 3-4 month timeframe, ensuring your Extracorporeal Circuit Waste Bag reaches the Indian market without unnecessary delays.
For detailed assistance and personalized consultation, contact our regulatory experts who specialize in nephrology and renal care devices.
By following this guide, manufacturers and importers can confidently navigate the CDSCO licensing process for Extracorporeal Circuit Waste Bags, ensuring compliance, market readiness, and patient safety.
