CDSCO License for Motorised Wheeled stretcher.
Medical Device Information
Intended Use
A motorised wheeled stretcher is a device intended to transport patients in a horizontal position as an assistance to injury or disability with a motorised mechanism.
Motorised Wheeled Stretcher: Regulatory Overview and Importance
A motorised wheeled stretcher is a vital medical device designed to transport patients horizontally with motorised assistance, primarily used in hospitals and orthopedic care settings. Given its role in patient safety and mobility, regulatory compliance is paramount to ensure quality, safety, and efficacy before market entry in India.
At our consultancy, with over 25 years of experience and having successfully guided 500+ companies, we understand the nuances involved in obtaining CDSCO licenses for such devices. This comprehensive guide walks you through the entire process for a Class B device like the Motorised Wheeled Stretcher, covering regulatory frameworks, risk classification, licensing procedures, costs, timelines, and practical tips.
CDSCO Regulatory Framework for Motorised Wheeled Stretchers
The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. The motorised wheeled stretcher falls under the category of General Hospital or Orthopaedic Instruments, notified under 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.
The device is classified as Class B, indicating low to moderate risk. Accordingly, manufacturers require an MD5 manufacturing license issued by the State Licensing Authority.
Risk Classification and License Requirements
The motorised wheeled stretcher is a Class B device. Here’s what that means for licensing:
- License Type: MD5 (Manufacturing License for Class A and B devices)
- Issuing Authority: State Licensing Authority
- Application Form: MD3
- Test License: Required prior to manufacturing license (Form MD13)
- Audit: Required by notified bodies
- Total Processing Time: Approximately 3-4 months
For detailed device classification, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Motorised Wheeled Stretchers
The manufacturing license process for Class B devices involves several critical steps:
Apply for Test License (Form MD13): This initial step allows you to manufacture the device for testing purposes. The test license is valid for up to 6 months and generally takes 1.5-2 months for approval.
Product Testing: Get the motorised wheeled stretcher tested in government-approved laboratories. You can find a list of CDSCO-approved testing labs here.
Documentation Preparation: Compile required documents including Device Master File, Plant Master File, risk management files, and more.
Apply for Manufacturing License (Form MD3): Submit the application through the CDSCO MD Online Portal.
Audit by Notified Body: The notified body conducts a detailed audit of your manufacturing site and QMS. Check the list of notified bodies authorized to perform these audits.
Resolve Queries: Address any observations or queries raised by the licensing authority or notified body promptly.
Grant of License (Form MD5): Upon satisfactory compliance, the State Licensing Authority issues the MD5 license.
For a stepwise overview, see our MD5 License Guide.
Manufacturing License Documents Required
Preparing a comprehensive dossier is crucial for smooth approval. For a motorised wheeled stretcher under Class B, you need:
- Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
- Proof of Ownership/Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience Documents
- Fire Safety NOC
- Pollution Control Board NOC
- Device Master File (DMF): Detailing device design, components, manufacturing process, sterilization, labeling, and packaging (learn more about DMF)
- Plant Master File (PMF): Describing manufacturing facility, equipment, processes, and quality control systems (PMF guide)
- Essential Principles Checklist (compliance with MDR)
- Risk Management File (risk management insights)
- Product Test Reports from CDSCO-approved labs
- Device Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation compliant with ISO 13485:2016
Import License Process (MD15) for Motorised Wheeled Stretchers
If you are an importer looking to bring motorised wheeled stretchers into India, the process is governed centrally by CDSCO through the MD15 license:
- Application Form: MD14
- Authority: Central Licensing Authority
- No Test License Required
- Documents Required: Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate (if applicable), Device Master File, Plant Master File, Wholesale License, Company Constitution
- Processing Time: Approximately 5-6 months
- Fees: Rs 2000 per site + Rs 1000 per product for Class B devices
- Apply via the CDSCO MD Online Portal
For detailed import licensing guidance, see our Import License Guide.
Import License Documents Required
Key documents for import licensing include:
- Valid Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File of the product
- Wholesale License for importers/distributors
- Constitution documents of importer company
Ensuring these documents are authentic and up-to-date is critical to avoid application delays.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 15 - 30 days |
| Document Preparation | 2 - 4 weeks |
| License Application Processing | 4 - 6 weeks |
| Audit and Query Resolution | 3 - 4 weeks |
| Total Manufacturing License Time | 3 - 4 months |
Import license applications (MD15) generally take 5-6 months due to central authority processing and document scrutiny.
Government Fees and Costs
For MD5 manufacturing licenses for Class B devices like motorised wheeled stretchers:
- Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
Additional costs include fees for notified body audits (varies by body) and product testing charges (approx Rs 20,000 to Rs 50,000 depending on test scope).
For import licenses (MD15), fees are higher due to central processing and product risk:
- Site Fee: Rs 2,000 per site
- Product Fee: Rs 1,000 per product
Budgeting for these is essential for smooth financial planning.
Common Challenges and Solutions
Challenge 1: Delays in product testing due to lab backlog.
- Solution: Engage with CDSCO-approved labs early and book testing slots in advance.
Challenge 2: Incomplete or inconsistent documentation causing queries.
- Solution: Use checklists and consult experts to ensure all technical files and certificates are accurate.
Challenge 3: Audit non-compliance issues.
- Solution: Conduct internal audits and mock inspections before notified body audits.
Challenge 4: Misclassification of device risk leading to incorrect licensing pathway.
- Solution: Confirm classification using CDSCO rules and expert consultation.
Expert Consultation and Support
Navigating CDSCO licensing for motorised wheeled stretchers requires specialized knowledge. Our team has helped over 500 companies successfully obtain MD5 and MD15 licenses by:
- Tailoring documentation to device-specific nuances
- Coordinating with notified bodies and testing labs
- Providing end-to-end application management
- Offering training on regulatory compliance and quality systems
Partnering with experienced consultants significantly reduces approval timelines and avoids costly rejections.
Getting Started with Your CDSCO License Application
If you manufacture motorised wheeled stretchers, here are your practical next steps:
- Assess your device classification using official CDSCO notifications.
- Prepare a detailed Device Master File and Plant Master File aligned with CDSCO requirements.
- Apply for the test license (Form MD13) via the CDSCO MD Online Portal.
- Schedule product testing at an approved laboratory.
- Compile all required documents including QMS and risk management files.
- Apply for the manufacturing license (Form MD3) online once testing is complete.
- Coordinate with a notified body for your audit.
- Respond promptly to queries from CDSCO or the notified body.
Starting early and engaging expert guidance can expedite your license grant and market entry.
For detailed guides on each step, visit our MD5 License Guide and consider contacting our regulatory specialists to discuss your specific project.
By approaching the CDSCO licensing process with a clear roadmap and thorough preparation, manufacturers and importers of motorised wheeled stretchers can confidently navigate regulatory requirements and bring safe, effective products to the Indian healthcare market.
