CDSCO License for Hand-carried stretcher.

Comprehensive CDSCO Licensing Guide for Hand-carried Stretchers (Class A Medical Device)

Hand-carried stretchers are essential medical devices used to safely transport patients with injuries or disabilities, especially within hospital or orthopedic settings. As a Class A medical device under the Indian regulatory framework, these stretchers require a clear and thorough compliance approach to obtain the necessary CDSCO manufacturing or import licenses. With over 25 years of experience assisting 500+ companies in successfully navigating CDSCO licensing, we provide you with a detailed, practical roadmap tailored specifically for hand-carried stretchers.

CDSCO Regulatory Framework for Hand-carried Stretchers

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Hand-carried stretchers fall under the category of General Hospital or Orthopaedic Instruments and are classified as Class A devices, representing low risk.

The applicable notification is 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022, which governs regulatory requirements for these devices. Compliance ensures safety and efficacy, facilitating smooth market entry within India.

Risk Classification and License Requirements for Class A Devices

Based on the Medical Device Classification framework, hand-carried stretchers are Class A devices. This classification mandates obtaining the MD5 Manufacturing License issued by the State Licensing Authority. The MD5 license process includes:

• Obtaining a Test License (Form MD13)
• Product testing from government-approved laboratories
• Documentation and audit by a notified body
• Final grant of license on Form MD5

For imports, separate licensing (MD15) applies but is beyond the scope of Class A manufacturing.

Detailed Manufacturing License Process (MD5) for Hand-carried Stretchers

Step 1: Apply for Test License (Form MD13)

Before manufacturing, manufacturers must apply for a Test License using Form MD13 through the CDSCO MD Online Portal. This license allows manufacturing of the device for testing purposes.

• Timeline: Approximately 1.5 to 2 months
• Purpose: Enables product testing and validation

Step 2: Product Testing

Testing must be conducted at CDSCO-approved laboratories. For hand-carried stretchers, mechanical strength, durability, labeling accuracy, and biocompatibility are critical parameters.

• Refer to the list of Testing Laboratories authorized by CDSCO
• Testing reports form a mandatory part of the license application

Step 3: Documentation Preparation

Comprehensive documentation is essential. This includes:

• Company Constitution and Ownership Proof
• Proof of Premises Ownership or Lease
• Qualification and Experience Certificates of Technical Staff
• Fire and Pollution NOCs
• Device Master File (DMF) detailing device design, components, and manufacturing process (Device Master File Guide)
• Plant Master File outlining manufacturing site details (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety standards
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents (ideally ISO 13485 compliant)

Step 4: Apply for MD5 Manufacturing License (Form MD3)

Once testing and document preparation are complete, apply for the MD5 license through the CDSCO portal. This application triggers the audit process.

Step 5: Audit by Notified Body

The State Licensing Authority nominates a notified body for a manufacturing site audit. The audit verifies:

• Compliance with QMS
• Adequacy of manufacturing processes
• Facility and staff qualifications
• Document authenticity

Consult the list of notified bodies before application.

Step 6: Query Resolution

Any observations or queries raised during the audit or by the CDSCO must be addressed promptly. Proactive communication significantly shortens processing times.

Step 7: Grant of MD5 License

Upon satisfactory compliance, the MD5 license is issued, authorizing manufacturing of hand-carried stretchers in India.

Manufacturing License Documents Required for Hand-carried Stretchers

Import License Process for Hand-carried Stretchers

While hand-carried stretchers are Class A devices primarily manufactured domestically with MD5 licenses, importers must obtain an MD15 license granted by the Central Licensing Authority. The process includes:

• Document preparation including existing manufacturing license, Free Sale Certificate, ISO 13485, CE Certificate
• Submission of application on Form MD14 via CDSCO MD Online Portal
• Query resolution and final grant of MD15 license

For detailed import licensing guidance, see our Import License Guide.

Timeline and Processing Duration

Planning your project timeline with these milestones reduces bottlenecks and accelerates market readiness.

Government Fees and Costs

Additional costs include product testing fees, notified body audit charges, and document preparation expenses. Generally, testing fees vary by lab and scope.

Common Challenges and Practical Solutions

• Incomplete Documentation: Many applicants face delays due to missing or inconsistent documents. We recommend using our Plant Master File Guide and Device Master File Guide for comprehensive documentation.

• Delayed Testing Results: Select CDSCO-approved labs early and confirm testing scope. Maintain regular follow-ups to avoid surprises.

• Audit Non-compliance: Prepare your manufacturing site and QMS rigorously. Conduct internal audits prior to CDSCO visits to identify gaps.

• Query Backlogs: Respond promptly with complete information. A dedicated regulatory liaison can streamline communications.

Expert Consultation and Support

With over 500 successful CDSCO licensing projects, our consultancy offers:

• Tailored regulatory strategy for hand-carried stretchers
• End-to-end assistance from test license application to final audit
• Document preparation and review services
• Liaison with notified bodies and CDSCO authorities

Engaging expert consultants can reduce licensing timelines by up to 30%, minimizing costly delays.

Getting Started with Your CDSCO License Application

To initiate your CDSCO licensing process for hand-carried stretchers:

1. Register on the CDSCO MD Online Portal
2. Apply for the Test License (MD13) immediately to kickstart product testing
3. Prepare your Device Master File and Plant Master File concurrently
4. Schedule product testing at an approved laboratory
5. Compile all required documentation meticulously
6. Plan a pre-audit internal review to ensure compliance
7. Submit your MD5 Manufacturing License application (Form MD3) via the portal

Taking these proactive steps will position your company for a smooth and timely market entry. Our team is ready to support every stage, ensuring regulatory compliance and business success in India’s growing medical device market.

For personalized assistance or queries, do not hesitate to reach out to our expert consultants specializing in CDSCO medical device licensing.