CDSCO License for Manual Wheeled stretcher.

Comprehensive Guide to CDSCO Licensing for Manual Wheeled Stretchers (Class A Medical Device)

As specialists with over 25 years of experience assisting 500+ companies in medical device regulatory compliance, we understand the critical importance of securing timely and accurate CDSCO licenses. Manual wheeled stretchers, classified as Class A devices under the Indian regulatory framework, are indispensable in hospitals and orthopedic care for safely transporting patients in a horizontal position. This guide walks you through every step to obtain your CDSCO manufacturing license (MD5) or import license (MD15) efficiently.

Understanding the CDSCO Regulatory Framework for Manual Wheeled Stretchers

Manual wheeled stretchers fall under the category of General Hospital or Orthopaedic Instruments, notified under the Gazette Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. As a Class A medical device, they are considered low risk but still require adherence to the Central Drugs Standard Control Organization (CDSCO) regulations for manufacturing and import.

The CDSCO classifies medical devices into four classes (A, B, C, D) based on risk, with Class A being low risk. This classification determines the licensing authority and process:

• Class A & B devices: Licensing by State Licensing Authority via MD5 license (Form MD3)
• Class C & D devices: Licensing by Central Licensing Authority via MD9 license
• Import licenses: Central Licensing Authority via MD15 license

Risk Classification and License Requirements for Manual Wheeled Stretchers

Since manual wheeled stretchers are Class A devices, manufacturers must obtain an MD5 license from the State Licensing Authority. Importers need an MD15 license from the Central Licensing Authority. The key regulatory requirements include:

• Compliance with Essential Principles of Safety and Performance
• Quality Management System (ISO 13485:2016) implementation
• Product testing from CDSCO-approved laboratories
• Submission of detailed documentation including Device Master File and Plant Master File

For a deeper dive into device classification, you can refer to our detailed Medical Device Classification guide.

Step-by-Step Manufacturing License Process (MD5) for Manual Wheeled Stretchers

1. Apply for Test License (Form MD13): Before the manufacturing license, obtain a test license allowing product testing. This takes approximately 1.5 to 2 months.
2. Product Testing: Get your manual wheeled stretcher tested at government-approved labs listed on the CDSCO Testing Laboratories page.
3. Documentation Preparation: Prepare comprehensive documents including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, test reports, labels, and Instructions for Use (IFU).
4. Application Submission: Submit your manufacturing license application (Form MD3) through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body from the approved list (Notified Bodies List) will conduct an audit of your manufacturing site and QMS.
6. Queries Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of License: Upon satisfactory review and audit, the MD5 license is granted.

For detailed guidance, our MD5 License Guide covers each step thoroughly.

Essential Documents Required for MD5 License Application

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF) – covering design and specifications (Device Master File Guide)
• Plant Master File (PMF) – detailing manufacturing processes and facilities (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance
• Risk Management File elaborating on hazard identification and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 compliant)

Import License Process (MD15) for Manual Wheeled Stretchers

If you are an importer wishing to bring manual wheeled stretchers into India, the process involves:

• Preparing required documents (including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate if applicable, Device and Plant Master Files, Wholesale License, and Company Constitution).
• Submitting application on Form MD14 via the CDSCO MD Online Portal.
• Resolving queries raised by the Central Licensing Authority.
• License grant on Form MD15.

The MD15 import license process typically takes 5-6 months. Further details are available in our Import License Guide.

Timeline and Processing Duration

Planning your project timeline around these durations helps avoid costly delays.

Government Fees and Costs

• MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Included in overall process, no separate fee usually
• MD15 Import License: Varies by class of device; for Class A devices approx. $1000 per site +$50 per product

Budgeting for government fees, notified body audits, testing, and consultancy services is crucial. For example, testing fees depend on the complexity and number of samples and typically range from Rs 20,000 to Rs 50,000 per product.

Common Challenges and Practical Solutions

• Incomplete Documentation: Meticulously prepare and cross-check documents beforehand to avoid back-and-forth.
• Audit Non-Compliance: Conduct pre-audit internal assessments to ensure QMS and manufacturing processes meet CDSCO standards.
• Testing Delays: Select accredited testing labs early and submit samples promptly.
• Query Resolution Delays: Assign dedicated regulatory personnel or consultants to respond quickly to CDSCO queries.

Our hands-on experience with over 500 companies equips us to help you navigate these challenges smoothly.

Expert Consultation and Support

Engaging a seasoned regulatory consultant can significantly accelerate your CDSCO licensing journey. We offer:

• Customized gap analysis and compliance roadmap
• Complete documentation preparation and review
• Coordination with notified bodies and testing labs
• End-to-end application submission and follow-up

Our in-depth knowledge of manual wheeled stretcher regulations and Class A device requirements ensures your application stands out for approval.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class A status and applicable license type.
2. Register on the CDSCO MD Online Portal: Begin your application process via CDSCO MD Online Portal.
3. Prepare Test License Application: Submit Form MD13 to start product testing.
4. Choose Accredited Testing Lab: Engage a CDSCO-approved lab promptly to minimize testing lead time.
5. Compile Complete Documentation: Utilize our Device Master File and Plant Master File guides.
6. Schedule Notified Body Audit: Coordinate audit timing with a notified body listed here.
7. Submit Final Application: Apply for the MD5 license with all supporting documents.

Taking these strategic steps early ensures a streamlined approval process for your manual wheeled stretcher manufacturing or import business in India. Contact us today for personalized assistance to navigate CDSCO requirements confidently and compliantly.