CDSCO License for Chair, Haemodialysis, Electrically powered/Manual.

Comprehensive Guide to CDSCO Licensing for Chair, Haemodialysis (Class A)

Navigating the regulatory landscape for medical devices in India is essential for manufacturers and importers aiming to successfully market products like the Chair, Haemodialysis (Electrically powered or Manual). As an expert regulatory consultancy with over 25 years of experience and having assisted 500+ companies, we provide detailed, actionable insights tailored for this Class A device in the nephrology and renal care category.

Understanding the Device and Its Regulatory Importance

The Chair, Haemodialysis is explicitly designed to support patients during haemodialysis by providing a safe, comfortable seated or reclined posture. Given its direct role in patient care during critical procedures, regulatory compliance ensures safety, quality, and reliability.

In India, the Central Drugs Standard Control Organisation (CDSCO) governs medical device licensing. Since your device falls under Class A, it is considered low risk but still requires a valid MD5 manufacturing license issued by the State Licensing Authority.

CDSCO Regulatory Framework for Chair, Haemodialysis (Class A)

The device is notified under Notification 29/Misc./03/2020-DC (143), dated 13.9.2021, categorizing it under Nephrology and Renal Care. This classification determines the licensing pathway:

• Class A (Low risk) devices: Require an MD5 license (Form MD3 application), granted by the State Licensing Authority.

This framework ensures that your haemodialysis chair meets all essential principles of safety, performance, and quality.

Risk Classification and License Requirements

Class A classification means the device poses minimal risk to patients and users. For such devices, the regulatory pathway is streamlined but still involves thorough documentation, testing, and compliance checks.

License Required: MD5 (Manufacturing License for Class A devices)

Application Form: MD3

Issuing Authority: State Licensing Authority

Approximate timeline: 3 to 4 months (including test license and audit)

Costs:

• Application fee: Rs 5,000 per application
• Product fee: Rs 500 per product

For a detailed understanding of device classification, visit our Medical Device Classification guide.

Manufacturing License Process (MD5) for Chair, Haemodialysis

The MD5 license process involves several critical steps:

1. Obtain Test License (Form MD13): Before applying for MD5, you must secure a test license to conduct product testing. This stage typically takes 1.5 to 2 months.

2. Product Testing: Get your haemodialysis chair tested at CDSCO-approved government laboratories. You can find the list of approved laboratories on the CDSCO Testing Laboratories page.

3. Document Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, and Risk Management File.

4. Apply for MD5 License (Form MD3): Submit your application through the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit by a notified body is mandatory to verify compliance. Check the list of notified bodies authorized for Class A device audits.

6. Respond to Queries: Address any observations or queries raised by the licensing authority or notified body promptly.

7. License Grant: Upon successful audit and document verification, the MD5 license is granted.

Manufacturing License Documents Required for MD5

Ensure the following documents are meticulously prepared and submitted:

• Company Constitution (Certificate of Incorporation/Partnership Deed)
• Proof of ownership or lease of manufacturing premises
• Qualification documents of technical staff involved in manufacturing
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed product specifications, manufacturing process, and quality controls. Our Device Master File guide offers practical tips for preparation.
• Plant Master File (PMF): Information on manufacturing infrastructure and equipment. Refer to our Plant Master File guide.
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File demonstrating hazard analysis and mitigation, aligned with ISO 14971 principles. Learn more about Risk Management.
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents, preferably ISO 13485:2016 certification or equivalent

Import License Process (MD15) for Chair, Haemodialysis

Though your focus may be manufacturing, importers seeking to bring this device into India must apply for an MD15 license via the Central Licensing Authority:

• Application Form: MD14
• Timeline: Approximately 5 to 6 months
• Costs:
  • Class A: $1000 per site,$50 per product
• Documents Required include Manufacturing License, Free Sale Certificate, ISO 13485 certification, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.

For a comprehensive overview, see our Import License guide.

Timeline and Processing Duration

Planning timelines realistically helps avoid last-minute rush and ensures smooth regulatory approvals.

Government Fees and Costs Breakdown

• MD5 License Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product (applicable per type/model of chair)
• Testing Costs: Varies depending on lab and number of tests; budget approximately Rs 50,000 to Rs 1,00,000
• Audit Charges: Paid to notified bodies separately; typically Rs 30,000 to Rs 50,000 depending on scope

Budgeting for these fees upfront prevents unexpected financial bottlenecks.

Common Challenges and Solutions

Challenge 1: Delays in product testing due to laboratory backlogs

• Solution: Pre-book testing slots early and engage with multiple approved labs.

Challenge 2: Incomplete or inconsistent documentation

• Solution: Use checklists aligned with CDSCO requirements and consult experts for document review.

Challenge 3: Audit non-conformities

• Solution: Conduct internal audits prior to notified body visits and maintain robust QMS processes.

Challenge 4: Query resolution delays

• Solution: Assign dedicated regulatory personnel to promptly respond with clear, evidence-backed answers.

Expert Consultation and Support

Our team has helped over 500 medical device companies achieve CDSCO licensing success. We provide end-to-end support:

• Gap analysis and document preparation
• Coordination with CDSCO-approved testing labs
• Audit readiness and mock inspections
• Timely query management

Partnering with experienced consultants significantly reduces the risk of rejection and speeds up market entry.

Getting Started with Your CDSCO License Application for Haemodialysis Chair

1. Assess Device Classification: Confirm Class A status and regulatory requirements.
2. Register on CDSCO MD Online Portal: Begin your journey by creating an account at the CDSCO MD Online Portal.
3. Apply for Test License (Form MD13): Prepare necessary documents and submit your application early.
4. Schedule Product Testing: Coordinate with CDSCO-approved labs to conduct mandatory tests.
5. Develop Comprehensive Documentation: Prepare Device Master File, Plant Master File, Risk Management File, and QMS documents.
6. Engage Notified Body: Identify and contract a notified body from the list of notified bodies for your audit.
7. Submit MD5 Application (Form MD3): Complete and submit your manufacturing license application.
8. Prepare for Audit & Inspection: Conduct internal audits and training to ensure compliance.
9. Respond Promptly to Queries: Maintain open communication with CDSCO and notified bodies.

By taking these strategic steps, you ensure a smooth and efficient regulatory journey for your Chair, Haemodialysis device, enabling timely access to the Indian market with full compliance.

For detailed guidance tailored to your specific needs, contact our expert regulatory team today and leverage our 25+ years of experience in CDSCO licensing.