CDSCO License for Hydraulic adjustable hospital bed.
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
Intended for medical purposes that consists of a bed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed.
Introduction to Hydraulic Adjustable Hospital Bed and Its Regulatory Importance
Hydraulic adjustable hospital beds are essential medical devices widely used in healthcare settings to improve patient comfort and care. These beds, equipped with a hydraulic mechanism operated by an attendant, allow adjustment of height and surface contour, facilitating medical procedures and enhancing patient mobility. Given their critical role in hospitals and orthopaedic care, these devices fall under the Class A category as per CDSCO regulations, requiring appropriate licensing before manufacturing or marketing in India.
Navigating the CDSCO regulatory framework is imperative to ensure compliance with safety, quality, and performance standards. With over 25 years of experience assisting 500+ companies, we provide detailed insights and practical guidance to streamline your licensing process for hydraulic adjustable hospital beds.
CDSCO Regulatory Framework for Hydraulic Adjustable Hospital Beds
Hydraulic adjustable hospital beds are categorized under General Hospital or Orthopaedic Instruments and notified under the Gazette Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. As per the latest CDSCO medical device regulations, such devices are classified as Class A – low risk.
The regulatory oversight for Class A devices is managed by State Licensing Authorities, and the manufacturing license is granted under Form MD5. Compliance involves obtaining a Test License (Form MD13), conducting product testing in government-approved laboratories, and an audit by a notified body.
For detailed classification, refer to our Medical Device Classification guide.
Risk Classification and License Requirements for Hydraulic Adjustable Hospital Beds
- Risk Class: A (Low risk)
- License Type: MD5 Manufacturing License
- Regulatory Authority: State Licensing Authority
- Applicable Forms:
- Test License: Form MD13
- Manufacturing License Application: Form MD3
- License Grant: Form MD5
The Class A classification implies a streamlined process but requires adherence to all regulatory stipulations, including quality management systems and product testing.
Manufacturing License Process (MD5) for Hydraulic Adjustable Hospital Beds
Apply for Test License (Form MD13): Initiate the process by applying for a test license to legally manufacture prototype products for testing purposes. This license is mandatory and typically takes 1.5 to 2 months for approval.
Product Testing: Conduct product testing at CDSCO-approved laboratories to verify compliance with essential principles. You can find the list of Testing Laboratories here.
Document Preparation: Prepare comprehensive documentation, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
Submit Manufacturing License Application (Form MD3): Upon successful testing, submit your application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body approved for Class A devices. Check the list of notified bodies for availability and scheduling.
Resolution of Queries: Address any questions or deficiencies raised by the regulatory authority or notified body promptly to avoid delays.
Grant of MD5 License: Upon successful audit and document verification, the State Licensing Authority grants the manufacturing license on Form MD5.
For a detailed walkthrough, our MD5 License Guide is an invaluable resource.
Manufacturing License Documents Required for Hydraulic Adjustable Hospital Beds
- Company Constitution (Certificate of Incorporation, Partnership Deed, etc.)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualifications of Technical Staff
- No Objection Certificates (NOC): Fire Safety, Pollution Control
- Device Master File (DMF) detailing design, specifications, and manufacturing process. Learn more from our Device Master File guide.
- Plant Master File (PMF) describing manufacturing facilities and equipment. Our Plant Master File Guide can assist in preparation.
- Essential Principles Checklist confirming compliance with safety and performance standards
- Risk Management File documenting hazard analysis and mitigation strategies. We recommend reviewing best practices in our Risk Management guide.
- Product Test Reports from government-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification is highly recommended)
Import License Process (MD15) for Hydraulic Adjustable Hospital Beds
While the hydraulic adjustable hospital bed is a Class A device primarily requiring a manufacturing license (MD5), importers seeking to bring these devices into India must obtain an Import License under Form MD15.
The import license application is submitted to the Central Licensing Authority via the CDSCO MD Online Portal. The process typically takes 5 to 6 months and involves:
- Submission of Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent international certification
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution documents
Government fees vary by device class and product count. For Class A devices, fees are approximately 50 per product.
For a detailed step-by-step procedure, see our Import License Guide.
Timeline and Processing Duration for Hydraulic Adjustable Hospital Bed Licensing
| Stage | Estimated Duration |
|---|---|
| Test License Approval (MD13) | 1.5 to 2 months |
| Product Testing | 2 to 3 weeks |
| Document Preparation | 2 to 4 weeks |
| Manufacturing License (MD5) Application Processing | 1 to 1.5 months |
| Audit & Query Resolution | 3 to 4 weeks |
| Total | Approximately 3 to 4 months |
Understanding these timelines helps manufacturers plan launch schedules and resource allocation effectively.
Government Fees and Costs for Hydraulic Adjustable Hospital Bed Licensing
- Test License (MD13): Included in overall process; nominal government fees apply
- Manufacturing License (MD5): Rs 5000 per application plus Rs 500 per product
- Product Testing: Charges vary by laboratory and number of tests; typically ranges from Rs 50,000 to Rs 1,00,000
- Audit Fees: Paid to notified bodies; approximately Rs 50,000 to Rs 1,00,000 depending on scope
Budgeting accurately for these costs is crucial to avoid funding shortfalls during the licensing process.
Common Challenges and Solutions in Obtaining CDSCO License for Hydraulic Adjustable Hospital Beds
Challenge: Delays in product testing due to laboratory backlogs.
- Solution: Schedule testing early and select laboratories with shorter turnaround times. Refer to the Testing Laboratories list for options.
Challenge: Incomplete or inconsistent documentation causing audit failures.
- Solution: Utilize standardized templates for Device Master File and Plant Master File. Engage expert consultants to review documents before submission.
Challenge: Queries and non-compliances raised during audit.
- Solution: Prepare thoroughly for audits by conducting internal pre-audits and staff training.
Challenge: Navigating changing regulatory requirements.
- Solution: Stay updated with CDSCO notifications and guidance documents, and maintain ongoing communication with the State Licensing Authority.
Expert Consultation and Support for Your Licensing Journey
With over two decades of experience and a track record of assisting over 500 companies, our regulatory consultancy offers end-to-end support:
- Comprehensive documentation preparation
- Coordination with notified bodies and testing labs
- Pre-audit readiness assessments
- Timely application filing and follow-up
- Customized training for your technical and regulatory teams
Partnering with experts significantly reduces approval timelines and enhances compliance robustness.
Getting Started with Your CDSCO License Application for Hydraulic Adjustable Hospital Beds
Assess Your Device Classification: Confirm that your hydraulic adjustable hospital bed is correctly classified as Class A.
Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
Plan Product Testing: Identify suitable government-approved testing laboratories and schedule tests promptly.
Compile Required Documentation: Leverage our guides on Device Master File and Plant Master File to assemble accurate and comprehensive dossiers.
Engage with a Notified Body: Early communication facilitates smoother audits. Review the list of notified bodies.
Prepare for Audit and Queries: Conduct internal reviews and ensure your team is audit-ready.
Submit Manufacturing License Application: File Form MD3 after successful testing and readiness.
Follow Up and Respond Promptly: Address any regulatory queries without delay.
Starting early and following a structured approach will position your company for successful market entry of hydraulic adjustable hospital beds in India. For personalized assistance, connect with our seasoned consultants who can tailor the process to your unique requirements.
By adhering to this comprehensive roadmap, manufacturers and importers can confidently navigate the CDSCO licensing process, ensuring timely approval and compliance for hydraulic adjustable hospital beds, ultimately contributing to improved healthcare delivery across India.
