CDSCO License for Haemofilters

Comprehensive Guide to CDSCO Licensing for Haemofilters (Class C Medical Device)

Haemofilters play a critical role in nephrology and renal care by facilitating haemofiltration — a process that removes toxins and replaces electrolytes in patients with kidney failure. Given their vital clinical use and complexity, haemofilters are classified as Class C medical devices under the CDSCO regulatory framework. Navigating the regulatory landscape for haemofilters requires in-depth knowledge and experience to ensure timely approval and market access in India.

With over 25 years of expertise and having supported 500+ companies in obtaining CDSCO licenses, we provide a detailed, practical roadmap tailored specifically for manufacturers and importers of haemofilters. This guide covers every step from classification to license issuance, including timelines, costs, documentation, and common challenges.

CDSCO Regulatory Framework for Haemofilters

Haemofilters fall under the nephrology and renal care category and are regulated as Class C devices due to their moderate to high risk profile. The CDSCO notification 29/Misc./03/2020-DC (143) dated 13.9.2021 explicitly includes haemofilters within this classification.

As a Class C device, haemofilters require a manufacturing license (MD9) issued by the Central Licensing Authority (CLA) and compliance with stringent quality and safety standards. The regulatory process involves laboratory testing, document submission, audits, and post-approval compliance.

For comprehensive details on medical device classification, manufacturers can review the Medical Device Classification guide.

Risk Classification and License Requirements for Haemofilters

Class C devices like haemofilters require an MD9 license, which is mandatory for both manufacturing and marketing within India.

Key regulatory steps include:

• Obtaining a Test License (Form MD13)
• Product testing in government-approved laboratories
• Submission of comprehensive documentation
• Audit by CDSCO inspectors
• Resolution of departmental queries
• Issuance of the MD9 manufacturing license

Manufacturing License Process for Haemofilters (MD9 License)

The MD9 license pathway for haemofilters involves the following sequential steps:

1. Application for Test License (Form MD13): This preliminary license allows the manufacturer to produce haemofilter samples specifically for testing purposes.
2. Product Testing: Samples are sent to CDSCO-approved testing laboratories for safety and efficacy evaluation. Testing typically covers biocompatibility, filtration efficiency, and material safety.
3. Documentation Preparation: Comprehensive files including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents are compiled.
4. Application Submission (Form MD7): The main application for the MD9 manufacturing license is submitted via the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: On-site audits verify compliance with manufacturing practices, quality controls, and document authenticity.
6. Query Resolution: The applicant addresses any queries or clarifications raised by CDSCO or the audit team.
7. Grant of MD9 License: Upon successful completion, the license is granted allowing commercial manufacturing and marketing.

For a deeper dive into the MD9 licensing process, refer to our MD9 License Guide.

Manufacturing License Documents Required for Haemofilters

Successful MD9 applications must include detailed documentation demonstrating compliance, including:

• Company Constitution Documents: Incorporation certificates, Memorandum & Articles of Association
• Proof of Premises Ownership or Lease Agreements
• Technical Staff Qualifications: CVs, certificates of engineers, quality managers
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device specifications, design, manufacturing process (Device Master File guide)
• Plant Master File (PMF): Manufacturing site details, equipment, infrastructure (Plant Master File guide)
• Essential Principles Checklist: Compliance with Indian medical device regulations
• Risk Management File: Hazard analysis, risk mitigation strategies (Risk Management reference)
• Test Reports: From CDSCO-approved laboratories (Testing Laboratories list)
• Labels and Instructions for Use (IFU): As per regulatory guidelines
• Quality Management System (QMS) Documents: ISO 13485 certification, SOPs, CAPA records

Thorough documentation reduces the risk of delays and rejections.

Import License Process for Haemofilters (MD15 License)

For importers looking to bring haemofilters into India, an MD15 import license is mandatory. The process includes:

• Gathering necessary documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
• Submitting the application on the CDSCO MD Online Portal using Form MD14.
• Addressing any queries raised by the CDSCO.
• Receiving the MD15 license allowing import and distribution.

Import licensing for Class C devices typically takes 5-6 months, considering the comprehensive document review.

For detailed information, consult our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate issued by the regulatory authority
• ISO 13485:2016 certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution Documents

Timeline and Processing Duration for Haemofilter Licensing

The entire process from test license application through final MD9 license issuance typically takes between 4 to 5 months. Delays may occur due to incomplete documentation or audit clarifications.

Government Fees and Costs for Haemofilters

• Test License (MD13): No separate fee but included in MD9 process
• MD9 License Application Fee: ₹50,000 per application
• Product Fee: ₹1,000 per product

Manufacturers should budget accordingly to cover testing, documentation preparation, and audit expenses. Additional costs may include consultancy, notified body fees, and product testing charges.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Plan sample testing early and select CDSCO-approved laboratories with proven turnaround times.

Challenge 2: Incomplete Documentation

• Solution: Use comprehensive checklists and expert consultation to prepare DMF, PMF, and Risk Management files meticulously.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal mock audits and train technical staff on CDSCO requirements before the official inspection.

Challenge 4: Query Resolution Delays

• Solution: Respond promptly with clear and complete information to avoid prolonged processing.

Expert Consultation and Support

Navigating the MD9 licensing process for haemofilters is complex but manageable with expert guidance. We have successfully helped over 500 companies streamline their regulatory submissions and approvals. Our services include:

• Gap analysis and documentation review
• DMF and PMF development
• Risk management and essential principles compliance
• Coordination with CDSCO and notified bodies (List of Notified Bodies)
• Audit preparation and training

Engaging experienced consultants reduces risks and accelerates market entry.

Getting Started with Your CDSCO License Application for Haemofilters

1. Assess Your Device Classification: Confirm haemofilters as Class C as per the latest CDSCO notification.
2. Prepare Documentation: Start compiling all required files, especially Device and Plant Master Files.
3. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
4. Arrange Product Testing: Coordinate with approved testing laboratories early.
5. Submit MD9 Application (Form MD7): Post test license and testing, submit complete application online.
6. Prepare for Audit: Ensure your manufacturing site and QMS comply with CDSCO standards.
7. Engage with CDSCO: Respond swiftly to queries and audit findings.

Starting early and leveraging expert assistance is key to a successful application. Contact us to initiate your haemofilter licensing journey with confidence and compliance.