CDSCO License for Hemodiafiltration system

Comprehensive Guide to CDSCO Licensing for Hemodiafiltration Systems

Hemodiafiltration systems play a critical role in nephrology and renal care by providing advanced blood purification using a hemodiafilter. Given their direct impact on patient health, these devices are categorized as Class C by the Central Drugs Standard Control Organisation (CDSCO) in India, requiring stringent regulatory compliance before market entry.

With over 25 years of experience assisting more than 500 medical device manufacturers and importers, we understand the nuances involved in securing CDSCO licensing for complex Class C devices like Hemodiafiltration systems. This guide offers detailed, practical insights into the regulatory framework, licensing process, documentation, fees, timelines, and common challenges you may face.

CDSCO Regulatory Framework for Hemodiafiltration Systems

The CDSCO governs medical device approval in India under the Medical Device Rules (MDR) 2017, amended periodically to align with global standards. Hemodiafiltration systems fall under Class C due to their moderate to high risk, necessitating central licensing authority oversight.

The relevant notification for this device is 29/Misc./03/2020-DC (143), dated 13.9.2021, which classifies Hemodiafiltration systems within nephrology and renal care devices.

Manufacturers and importers must comply with:

• Obtaining an MD9 manufacturing license for domestic production
• Acquiring an MD15 import license if sourcing from abroad
• Adherence to Quality Management Systems, including ISO 13485:2016
• Submission of technical dossiers such as Device Master File and Plant Master File

We recommend frequent consultation of the CDSCO MD Online Portal for application submissions and status tracking.

Risk Classification and License Requirements for Hemodiafiltration Systems

As a Class C device, Hemodiafiltration systems require the MD9 license, which is issued by the central licensing authority. This classification reflects the device’s invasive nature and its critical role in patient survival.

Key implications of Class C risk classification:

• Mandatory type testing from CDSCO-approved laboratories
• In-depth audit by CDSCO inspectors
• Comprehensive review of risk management and clinical data

For reference on device classification, visit our Medical Device Classification guide.

Manufacturing License Process (MD9) for Hemodiafiltration Systems

Securing an MD9 license involves a multi-step process:

1. Test License (Form MD13): Before the manufacturing license, you must obtain a test license, which takes approximately 1.5 to 2 months. This allows product testing in government-approved labs.
2. Product Testing: Conduct testing at CDSCO-recognized laboratories to validate safety and performance. See the Testing Laboratories list.
3. Document Preparation: Compile the technical dossier including Device Master File, Plant Master File, risk management files, and clinical evaluation reports.
4. Application Submission (Form MD7): Submit the MD9 application via the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors: After document review, the CDSCO conducts an on-site audit to verify compliance with Good Manufacturing Practices (GMP).
6. Query Resolution: Address any queries or deficiencies raised by CDSCO or auditors promptly.
7. License Grant (Form MD9): Upon successful audit and document compliance, the MD9 manufacturing license is issued.

We provide a detailed walkthrough in our MD9 License Guide.

Manufacturing License Documents Required for Hemodiafiltration Systems

The documentation package must be comprehensive and organized:

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing design, materials, and manufacturing process (Device Master File Guide)
• Plant Master File outlining facility layout and equipment (Plant Master File Guide)
• Essential Principles Checklist confirming conformity with Indian MDR
• Risk Management File compliant with ISO 14971 (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System documentation, including ISO 13485:2016 certification

Ensuring accuracy and completeness of these documents significantly reduces review time and audit queries.

Import License Process (MD15) for Hemodiafiltration Systems

For importers, obtaining the MD15 import license is mandatory prior to distribution in India. The process is as follows:

1. Document Preparation: Collect manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
2. Application Submission (Form MD14): Submit the MD15 application via the CDSCO MD Online Portal.
3. Review and Query Resolution: CDSCO examines the dossier and may raise queries.
4. License Issuance (Form MD15): Upon satisfactory review, the import license is granted.

Note that the MD15 process typically takes 5-6 months, and unlike MD9, no test license is required beforehand.

Learn more from our Import License Guide.

Import License Documents Required for Hemodiafiltration Systems

• Valid Manufacturing License from country of origin
• Free Sale Certificate or Equivalent
• ISO 13485:2016 Certificate
• CE Certificate or other recognized conformity assessment
• Device Master File
• Plant Master File
• Wholesale License in India
• Company Constitution and Registration Documents

Providing complete and certified translations of foreign certificates expedites processing.

Timeline and Processing Duration for Hemodiafiltration Systems

Bear in mind that timelines can be affected by the completeness of submissions and timely responses to CDSCO queries.

Government Fees and Costs for Hemodiafiltration Systems Licensing

• MD9 License Fee: Rs 50,000 per application + Rs 1,000 per product
• MD15 Import License Fee:
  • Class C & D: $3,000 per site +$1,500 per product

Additional costs include:

• Product testing fees at government-approved labs
• Notified body audit charges
• Consultancy fees (if applicable)

Investing in professional support can minimize delays and compliance risks.

Common Challenges and Solutions in CDSCO Licensing for Hemodiafiltration Systems

• Incomplete Documentation: Ensure all files, especially risk management and test reports, follow CDSCO formats.
• Delays in Product Testing: Pre-book testing slots at notified labs to avoid bottlenecks.
• Audit Non-Compliance: Conduct internal audits to identify gaps before CDSCO inspections.
• Query Management: Respond to CDSCO queries comprehensively and within stipulated timelines.

Our consultancy has resolved these issues repeatedly, helping clients achieve timely approvals.

Expert Consultation and Support for Hemodiafiltration Systems

Navigating the Indian regulatory landscape can be complex. Our team offers end-to-end support including:

• Gap analysis and readiness assessment
• Document preparation and review
• Coordination with testing labs and notified bodies (Notified Bodies List)
• On-site audit assistance
• Post-license compliance advisory

Partnering with experienced consultants reduces risk and accelerates market entry.

Getting Started with Your CDSCO License Application for Hemodiafiltration Systems

1. Determine Your Route: Decide whether you will manufacture locally (MD9) or import (MD15).
2. Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the application interface.
3. Compile Required Documents: Begin gathering your Device Master File, Plant Master File, QMS certificates, and other essential documents.
4. Plan Product Testing: Schedule testing at an approved government laboratory early to avoid delays.
5. Engage a Notified Body: For MD9 applications, select a notified body from the official list for audits.
6. Submit Test License (if applicable): Apply for the test license (Form MD13) as the first formal step.
7. Prepare for Audit: Conduct internal audits and gap assessments to ensure compliance.
8. Submit Complete Application: File your application on the portal with all supporting documents.
9. Track Application Status: Monitor progress and respond promptly to CDSCO communications.

Starting early and maintaining clear communication with regulatory authorities and stakeholders is key to success.

For detailed support and personalized assistance, reach out to our MD9 License Guide and let our expertise work for you.