CDSCO License for Swivel-walker

Comprehensive Guide to CDSCO Licensing for Swivel-walker (Class A Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we understand the nuances and requirements involved in bringing medical devices like the Swivel-walker to the Indian market. This guide offers an in-depth, step-by-step approach to obtaining your CDSCO license, focusing specifically on Class A devices such as the Swivel-walker—a physical support device designed to aid patients who cannot stand unassisted.

Introduction: Swivel-walker and Its Regulatory Importance

The Swivel-walker is a Class A medical device intended to provide physical support by enabling patients to walk through a unique rocking and swiveling mechanism. Given its intended use to assist mobility and prevent falls, it falls under the Indian regulatory framework established by the Central Drugs Standard Control Organization (CDSCO).

Securing a CDSCO license is mandatory before manufacturing or importing this device in India, ensuring safety, efficacy, and compliance with national standards. Failure to comply can lead to legal repercussions, product recalls, and loss of market access.

CDSCO Regulatory Framework for Swivel-walker

Under the Medical Device Rules (MDR) 2017, devices are classified into Classes A, B, C, and D based on risk. The Swivel-walker, categorized as a Class A device, is considered low risk. Consequently, the manufacturing license is granted by the State Licensing Authority via the MD5 license process.

The regulatory pathway includes:

• Obtaining a Test License (Form MD13) for product testing
• Product testing at CDSCO-approved laboratories
• Preparation and submission of a comprehensive application (Form MD3)
• Audit by a notified body
• Resolution of queries raised by the licensing authority

Risk Classification and License Requirements

The Swivel-walker, as a Class A device, requires an MD5 manufacturing license. This involves a streamlined process managed by the State Licensing Authority. For importers, the MD15 import license is applicable, but this guide focuses on domestic manufacturers.

Refer to the Medical Device Classification guide for detailed classification criteria.

Manufacturing License Process (MD5) for Swivel-walker

1. Apply for Test License (Form MD13): Before manufacturing, you must obtain a test license valid for 12 months. This allows for sample testing and validation.

2. Product Testing: Conduct tests at CDSCO-recognized labs. You can find the list of Testing Laboratories here.

3. Application Preparation: Prepare the application dossier including technical documentation, Device Master File, Plant Master File, and quality management system details.

4. Submit Application (Form MD3): Apply via the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit will be conducted by a notified body from the authorized list. Check the Notified Bodies List to select your auditor.

6. Respond to Queries: Address any queries raised by the State Licensing Authority or the notified body promptly.

7. License Grant (Form MD5): Once compliance is confirmed, the license is issued allowing manufacturing to commence.

Manufacturing License Documents Required

For the Swivel-walker MD5 license application, ensure you have the following documents:

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, materials, and specifications (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing processes and facilities (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File complying with ISO 14971 principles (Risk Management)
• Product Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 recommended)

Import License Process (MD15) for Swivel-walker

Though primarily focused on manufacturing, importers of the Swivel-walker must apply for an MD15 license from the Central Licensing Authority. The process involves:

• Preparation of comprehensive documentation including manufacturing license of the source country, Free Sale Certificate, ISO 13485:2016 certification, CE certification, and device-specific files
• Application submission on the CDSCO MD Online Portal
• Resolution of queries
• Grant of import license (Form MD15)

For detailed guidance, review the Import License Guide.

Timeline and Processing Duration

For Class A devices like the Swivel-walker, the typical timeline is as follows:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months
• Application Submission and Audit: 1 to 1.5 months
• Query Resolution and Final Approval: 0.5 to 1 month

Total estimated duration: Approximately 3 to 4 months from test license application to final MD5 license grant.

Government Fees and Costs

The fee structure for the MD5 license is as follows:

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

Additional costs to consider:

• Testing laboratory fees (varies by test scope)
• Notified body audit fees (depend on auditor selected)
• Consultant fees if engaging regulatory experts

Budgeting accurately for these costs avoids delays and ensures smooth application progression.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or unclear risk management files.

Solution: Utilize our comprehensive checklists and templates for Device Master File and Risk Management to ensure completeness upfront.

Challenge: Audit non-compliance findings.

Solution: Conduct internal pre-audit readiness assessments and engage notified bodies early for clarifications.

Challenge: Prolonged query resolution.

Solution: Maintain prompt communication with CDSCO officials and prepare detailed, evidence-backed responses.

Expert Consultation and Support

Navigating the CDSCO licensing process can be complex, particularly for first-time manufacturers. Our expert consultancy has successfully guided over 500 companies through obtaining MD5 licenses for Class A devices like the Swivel-walker. We offer:

• Tailored document preparation assistance
• Liaison with notified bodies and CDSCO authorities
• Pre-audit training and gap analysis
• Post-approval compliance support

Getting Started with Your CDSCO License Application

To initiate your licensing journey:

1. Assess your product classification: Confirm Swivel-walker is Class A using the Medical Device Classification resources.

2. Register on the CDSCO MD Online Portal: Create your account to access submission forms and status tracking.

3. Prepare your Test License application (Form MD13): Gather initial documents and submit.

4. Plan your product testing: Identify appropriate laboratories from the Testing Laboratories list.

5. Develop your Device and Plant Master Files: Use our detailed guides to create compliant documentation.

6. Schedule your notified body audit: Select an auditor from the Notified Bodies List and coordinate timing.

Taking these proactive steps will streamline your CDSCO licensing process and accelerate your market entry.

For personalized assistance or to discuss your Swivel-walker project, contact our expert team today and leverage our 25+ years of regulatory excellence.