CDSCO License for Haemodialysis Catheter

Comprehensive Guide to CDSCO Licensing for Haemodialysis Catheters (Class B Medical Device)

As a medical device manufacturer or importer targeting the Indian market, obtaining the appropriate CDSCO license for your haemodialysis catheter is crucial. Classified as a Class B device, haemodialysis catheters—used to facilitate blood exchange to and from haemodialysis machines—are regulated stringently under CDSCO guidelines to ensure safety and efficacy. With our 25+ years of experience supporting over 500 companies, we provide a detailed walkthrough of the entire licensing process, tailored specifically to haemodialysis catheters.

CDSCO Regulatory Framework for Haemodialysis Catheters

The Central Drugs Standard Control Organization (CDSCO) oversees medical device regulation in India, following the Medical Devices Rules, 2017, notified under the Drugs and Cosmetics Act. Haemodialysis catheters fall under Rule 23 of the Medical Devices Rules and are classified as Class B devices due to their moderate risk profile. The regulatory framework mandates obtaining a manufacturing license (Form MD5) before production and sale in India.

Risk Classification and License Requirements for Haemodialysis Catheters

According to the Medical Device Classification, haemodialysis catheters are Class B devices. This classification requires manufacturers to apply for an MD5 license, regulated by the State Licensing Authority. The entire process, including testing and audit, typically takes 3 to 4 months. Importers, meanwhile, must apply for the MD15 import license through the Central Licensing Authority.

Manufacturing License Process (MD5) for Haemodialysis Catheters

The MD5 license process involves several key steps:

1. Test License (Form MD13): Obtain a test license to manufacture samples for testing. This initial phase takes approximately 1.5 to 2 months.
2. Product Testing: Have your haemodialysis catheters tested at a CDSCO-approved government laboratory. You can find the updated list of Testing Laboratories on the CDSCO portal.
3. Document Preparation: Compile all necessary documents, including technical files and quality management system evidence.
4. Application Submission (Form MD3): Apply for the manufacturing license through the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo an audit by a notified body to assess compliance with manufacturing and quality requirements. Check the list of notified bodies for eligible auditors.
6. Query Resolution: Address any queries raised by the licensing authority or notified body.
7. Grant of License: Upon successful audit and compliance, the manufacturing license (Form MD5) is granted.

Manufacturing License Documents Required for Haemodialysis Catheters

A comprehensive document set is essential for smooth application processing:

• Company Constitution: Certificate of incorporation or partnership deed.
• Proof of Premises Ownership/Lease: Valid ownership documents and site address proof.
• Technical Staff Qualifications: Detailed CVs and qualifications of key technical personnel.
• Fire NOC and Pollution Control NOC: Certificates from relevant local authorities.
• Device Master File (DMF): Detailed product specifications, design, manufacturing process, and quality controls. Our Device Master File guide provides in-depth steps.
• Plant Master File (PMF): Documentation of manufacturing facility, processes, and quality assurance systems. See our Plant Master File guide for a practical approach.
• Essential Principles Checklist: Compliance checklist as per Medical Device Rules.
• Risk Management File: Documentation of risk analysis and mitigation strategies per ISO 14971 standards. Learn more on Risk Management.
• Test Reports: Reports from government-approved testing laboratories.
• Labels and Instructions for Use (IFU): Proposed labeling and user manuals.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and related SOPs.

Import License Process (MD15) for Haemodialysis Catheters

For importers, the MD15 license is mandatory and handled by the Central Licensing Authority. The process includes:

• Document Preparation: Assemble all required documents including manufacturing license, certificates, and quality evidence.
• Application Submission: File the application on the CDSCO MD Online Portal.
• Queries and Review: Address clarifications from the regulatory body.
• License Grant: Received on Form MD15, generally within 5 to 6 months.

Import License Documents Required

• Valid Manufacturing License (MD5/MD9) from the country of origin.
• Free Sale Certificate issued by the competent authority of the exporting country.
• ISO 13485:2016 Certification.
• CE Certificate or equivalent international certification.
• Device Master File and Plant Master File.
• Wholesale License in India.
• Company Constitution and other relevant statutory documents.

Timeline and Processing Duration

For import licenses (MD15), expect 5 to 6 months due to centralized processing.

Government Fees and Costs

• MD5 License (Class B device):

  • Rs 5,000 per application
  • Rs 500 per product

• MD15 Import License:

  • Rs 2,000 per site
  • Rs 1,000 per product

Additional costs include testing laboratory fees (varies by lab and testing scope) and audit charges by notified bodies.

Common Challenges and Solutions

• Delays in Testing: Government labs may have backlogs. Mitigate by scheduling tests early and considering accredited private labs if available.
• Incomplete Documentation: Ensure all files, especially Device and Plant Master Files, are detailed and accurate. Use expert consultancy for proper documentation.
• Audit Non-compliance: Prepare thoroughly by aligning your QMS and manufacturing processes with notified body requirements.
• Query Management: Respond promptly and comprehensively to regulatory queries to avoid processing delays.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for specialized devices like haemodialysis catheters. Our seasoned consultants assist with:

• End-to-end application preparation
• Device Master File and Plant Master File creation
• Scheduling and managing audits
• Liaising with CDSCO and notified bodies
• Training your team on compliance requirements

Getting Started with Your CDSCO License Application

1. Assess your device classification and confirm it as Class B.
2. Register on the CDSCO MD Online Portal.
3. Apply for the Test License (MD13) to produce samples for testing.
4. Engage a CDSCO-approved testing laboratory early to schedule required tests.
5. Prepare Device and Plant Master Files with detailed, compliant documentation.
6. Plan your notified body audit and coordinate all QMS and facility requirements.
7. Submit your manufacturing license application (MD5) after test reports and audit readiness.

By following these actionable steps and leveraging expert support, manufacturers and importers can smoothly obtain CDSCO approval for haemodialysis catheters, ensuring timely market entry and regulatory compliance.

For detailed assistance, please contact our regulatory team who has successfully guided over 500 companies through the CDSCO licensing process, delivering efficient, hassle-free approvals.