CDSCO License for Peritoneal Dialysis Transfer Set

Comprehensive Guide to CDSCO Licensing for Peritoneal Dialysis Transfer Sets (Class B Medical Device)

Introduction: Understanding Peritoneal Dialysis Transfer Sets and Regulatory Importance

Peritoneal Dialysis Transfer Sets are critical components used in nephrology and renal care to facilitate the connection between a patient’s catheter and dialysis solution bag. These transfer sets include highly specialized tubing and connectors designed to maintain a sterile and secure pathway during peritoneal dialysis treatments. Given their direct role in patient safety and infection control, regulatory oversight is stringent.

In India, the Central Drugs Standard Control Organization (CDSCO) regulates such devices under the Medical Device Rules (MDR) 2017 framework. Compliance with CDSCO licensing requirements ensures product safety, quality, and market access. For manufacturers and importers of Peritoneal Dialysis Transfer Sets, obtaining a valid CDSCO license is not just a legal mandate but a crucial step to build trust with healthcare providers and patients.

CDSCO Regulatory Framework for Peritoneal Dialysis Transfer Sets

As per the latest notification (29/Misc./03/2020-DC (143)) dated 13.9.2021, Peritoneal Dialysis Transfer Sets fall under the nephrology and renal care category and are classified under Risk Class B. This classification implicates a moderate risk profile requiring a State Licensing Authority-issued manufacturing license (MD5).

The regulatory process integrates product testing, quality management system audits, and comprehensive documentation to align with the Essential Principles of Medical Device Safety and Performance outlined by CDSCO.

Risk Classification and License Requirements for Class B Devices

Class B devices are considered low to moderate risk, demanding a meticulous but less stringent regulatory pathway compared to Class C or D devices. For Peritoneal Dialysis Transfer Sets:

• License Type: MD5 Manufacturing License
• Governing Authority: State Licensing Authority
• Application Form: MD3
• Typical Processing Time: 3-4 months (including test license and audit)
• Fees: Rs 5,000 per application + Rs 500 per product

This pathway ensures that manufacturers comply with safety standards without the extended timelines typical of higher-risk devices.

Manufacturing License Process (MD5) for Peritoneal Dialysis Transfer Sets

The manufacturing license process involves several sequential steps designed to verify product safety and manufacturing capability:

1. Test License (Form MD13): Initially, companies must apply for a test license to allow product testing. This takes approximately 1.5 to 2 months.
2. Product Testing: Testing must be conducted at CDSCO-approved laboratories. Given the complexity of dialysis transfer sets, parameters like biocompatibility, sterility, and physical integrity are rigorously evaluated. Refer to the list of CDSCO Testing Laboratories for approved facilities.
3. Documentation Preparation: This includes compiling the Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist. We recommend following our detailed Device Master File Guide and Plant Master File Guide to streamline this phase.
4. License Application Submission: Submit your complete application via the CDSCO MD Online Portal.
5. Audit by Notified Body: After submission, a notified body conducts an on-site audit to verify compliance with Good Manufacturing Practices (GMP). The list of Notified Bodies can be consulted for selecting the right auditor.
6. Query Resolution: Address any observations or queries from the CDSCO or notified body promptly.
7. License Grant: Upon successful completion, CDSCO issues the MD5 license enabling legal manufacturing and sale in India.

Manufacturing License Documents Required

For Peritoneal Dialysis Transfer Sets, ensure the following documents are meticulously prepared:

• Company Constitution and Incorporation Certificate
• Proof of ownership or lease of manufacturing premises
• Technical staff qualifications and appointment letters
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (detailing design, specifications, manufacturing process)
• Plant Master File (detailing manufacturing site, machinery, quality controls)
• Essential Principles Checklist
• Risk Management File (with hazard analysis and mitigation strategies)
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certified

We advise leveraging our proven templates and checklists to avoid common pitfalls.

Import License Process (MD15) for Peritoneal Dialysis Transfer Sets

If you are an importer rather than a manufacturer, obtaining an MD15 import license from the Central Licensing Authority is mandatory. This process generally takes 5-6 months.

Key steps include:

• Compile requisite documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate if applicable, Device and Plant Master Files, wholesale license, and company constitution.
• Submit the application on the CDSCO MD Online Portal.
• Respond to any queries raised by CDSCO.
• Once approved, receive the MD15 license to legally import the device.

Government fees vary by risk class, with Class B devices incurring Rs 2000 per site and Rs 1000 per product approximately.

For detailed guidance, consult our Import License Guide.

Timeline and Processing Duration

Planning your project timeline accordingly helps meet market launch targets without delays.

Government Fees and Costs

• Test License (MD13): Typically Rs 5,000
• MD5 Manufacturing License Application: Rs 5,000
• Per Product Fee: Rs 500

Additional costs include notified body audit fees and testing charges, which vary depending on the notified body and laboratory chosen. Budgeting for these expenses early can prevent surprises.

Common Challenges and Solutions

Challenge: Delays in test report availability due to limited testing slots.

Solution: Schedule testing promptly after receiving the test license and consider multiple CDSCO-approved labs to reduce lead time.

Challenge: Documentation gaps leading to audit non-compliance.

Solution: Engage with experienced consultants to prepare and review your DMF, PMF, and Risk Management File in advance.

Challenge: Queries raised by CDSCO causing process slowdowns.

Solution: Maintain proactive communication with CDSCO officers and prepare comprehensive responses with supporting evidence.

Expert Consultation and Support

With over 25 years of experience assisting 500+ companies in navigating CDSCO licensing, we provide end-to-end support—from initial classification to audit preparation and post-license compliance. Our industry insights and practical strategies ensure your Peritoneal Dialysis Transfer Set gains timely approval for Indian market entry.

Getting Started with Your CDSCO License Application

1. Device Classification Confirmation: Verify your device’s Class B status under the MDR 2017 using resources like our Medical Device Classification guide.
2. Initiate Test License Application: Prepare Form MD13 and compile preliminary product information.
3. Select Testing Laboratory: Choose from CDSCO-approved labs to schedule required product tests.
4. Prepare Documentation: Start gathering and drafting your Device Master File, Plant Master File, and Risk Management documents.
5. Plan Audit Readiness: Engage a notified body early to understand audit prerequisites.
6. Submit Applications via CDSCO MD Online Portal: Utilize the official portal for seamless submission.
7. Monitor Application Progress: Track status regularly and respond to queries promptly.

Embarking on your CDSCO licensing journey with a clear roadmap and expert support can dramatically improve your chances of success. Contact us today to discuss tailored solutions for your Peritoneal Dialysis Transfer Set manufacturing or import licensing needs.