CDSCO License for Haemodialyzer reprocessing system

Comprehensive Guide for CDSCO Licensing of Haemodialyzer Reprocessing Systems (Class C Medical Device)

Introduction: Understanding Haemodialyzer Reprocessing Systems and Their Regulatory Significance

Haemodialyzer reprocessing systems play a critical role in nephrology and renal care by enabling the safe cleaning, rinsing, testing, and disinfecting of haemodialysis dialyzers for reuse. Given their direct impact on patient safety and infection control, these devices are classified under Class C risk category by the Central Drugs Standard Control Organization (CDSCO) in India. Compliance with CDSCO regulations is not only mandatory but ensures the highest standards of quality and safety to protect end-users.

At our consultancy, with over 25 years of specialized experience and having supported 500+ companies, we understand the nuances and complexities involved in obtaining a CDSCO license for this device type. This guide offers you an actionable roadmap tailored explicitly for haemodialyzer reprocessing systems.

CDSCO Regulatory Framework for Haemodialyzer Reprocessing Systems

The CDSCO regulates all medical devices under the Medical Devices Rules, 2017. Since haemodialyzer reprocessing systems are classified as Class C devices (moderate to high risk), they fall under the Central Licensing Authority’s purview. The applicable license for manufacturing is the MD9 license (Form MD7).

This device is notified under Notification No. 29/Misc./03/2020-DC (143), dated 13.9.2021, which clearly mandates compliance with CDSCO regulations before manufacturing or importing into India.

Risk Classification and License Requirements for Haemodialyzer Reprocessing Systems

• Risk Class: C (moderate to high risk)
• Regulatory Authority: Central Licensing Authority
• Manufacturing License: MD9 (Form MD7)
• Import License: MD15 (Form MD14)

Manufacturers must obtain an MD9 manufacturing license before commencing production. Importers must secure an MD15 import license.

For detailed information about device classification and risk management, manufacturers can visit our Medical Device Classification and Risk Management guides.

Manufacturing License Process (MD9) for Haemodialyzer Reprocessing Systems

The MD9 manufacturing license process is comprehensive and includes several critical steps:

1. Test License (Form MD13): First, apply for a test license which typically takes 1.5 to 2 months. This allows you to manufacture the device for testing purposes.
2. Product Testing: Get your devices tested at government-approved laboratories. Refer to the Testing Laboratories list for authorized labs.
3. Document Preparation: Compile the required documentation including technical files, quality systems, and compliance evidence.
4. License Application (Form MD7): Submit your MD9 application through the CDSCO MD Online Portal.
5. Audit & Inspection: CDSCO inspectors will conduct a thorough audit of your manufacturing facility and quality management system.
6. Query Resolution: Address any queries raised by the CDSCO or auditors promptly.
7. License Grant: Upon successful review, the MD9 license will be granted.

Manufacturing License Documents Required for MD9

• Company Constitution (MOA/AOA)
• Proof of ownership/lease of manufacturing premises
• Details and qualifications of technical staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) – detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) – facility and process details (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File
• Test Reports from government-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents including ISO 13485:2016 certification

Import License Process (MD15) for Haemodialyzer Reprocessing Systems

For importers, the process to obtain an MD15 license is as follows:

1. Document Compilation: Prepare all mandatory documents including manufacturing license of foreign manufacturer, Free Sale Certificate, ISO 13485 certificate, CE marking, and technical files.
2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
3. Review & Queries: The central authority reviews the application and may raise queries.
4. License Issuance: Upon satisfactory resolution of queries, the MD15 license is granted.

Import License Documents Required for MD15

• Valid manufacturing license of foreign manufacturer
• Free Sale Certificate from country of origin
• ISO 13485:2016 certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale license in India
• Company Constitution Documents
• Detailed product description and labelling

Timeline and Processing Duration

Planning is crucial. Delays commonly arise from incomplete documentation or slow response to CDSCO queries. Early preparation and expert review can shorten timelines.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000

• Test License (MD13):

  • Separate fees applicable (varies by device and region)

• MD15 Import License Fees:

  • Class C Devices: $3000 per site +$1500 per product (approximate INR equivalent)

Budgeting must account for these fees plus costs related to testing, audits, and consultancy.

Common Challenges and Practical Solutions

Challenge: Difficulty in compiling comprehensive technical documentation such as Device Master Files and Risk Management Files.

Solution: Utilize expert guidance and our detailed Device Master File Guide and Risk Management resources to prepare accurate and compliant files.

Challenge: Delays due to audit findings and query resolution.

Solution: Conduct pre-audit internal assessments and maintain prompt, transparent communication with CDSCO inspectors and notified bodies.

Challenge: Identifying authorized testing laboratories.

Solution: Refer to the official Testing Laboratories list to select accredited labs for product testing.

Expert Consultation and Support

With decades of experience assisting over 500 medical device manufacturers and importers, we provide end-to-end support—from documentation drafting and test license procurement to audit readiness and final license submission. Our tailored approach ensures your haemodialyzer reprocessing system meets all CDSCO requirements efficiently.

Getting Started with Your CDSCO License Application for Haemodialyzer Reprocessing Systems

1. Assess Device Classification: Confirm the Class C classification and regulatory obligations.
2. Prepare Documentation: Start compiling your Device Master File, Plant Master File, and Risk Management files early.
3. Apply for Test License (MD13): Submit your test license application on the CDSCO MD Online Portal.
4. Arrange Product Testing: Coordinate with government-approved labs for mandatory product testing.
5. Submit MD9 Application: After successful testing, apply for the manufacturing license using Form MD7.
6. Prepare for Audit: Conduct internal audits and readiness checks.
7. Engage with CDSCO: Respond rapidly to any queries or observations.

Embarking on this process with professional guidance minimizes risks of rejection or delay. Contact us to leverage our expertise and streamline your journey to obtaining the CDSCO MD9 license for your haemodialyzer reprocessing system.

For further assistance and personalized consultation, visit our comprehensive MD9 License Guide or reach out directly for expert support tailored to your needs.