CDSCO License for Manual adjustable hospital bed.

Comprehensive Guide to CDSCO Licensing for Manual Adjustable Hospital Beds (Class A)

Manual adjustable hospital beds are essential medical devices designed to provide comfort and support for patients in healthcare settings. Operated manually by attendants, these beds allow adjustments in height and contour to meet patient needs. Classified under Class A as per CDSCO regulations, these devices fall under the category of General Hospital or Orthopaedic Instruments. Obtaining the correct CDSCO license is critical for manufacturers and importers aiming to enter or expand in the Indian market.

With over 25 years of regulatory consulting experience and having successfully assisted 500+ companies, we provide you with a detailed, step-by-step roadmap to secure your CDSCO license for manual adjustable hospital beds under notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.

CDSCO Regulatory Framework for Manual Adjustable Hospital Beds

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules 2017. Manual adjustable hospital beds are categorized as Class A devices, indicating a low risk to patient health and safety. This classification impacts the licensing authority and the regulatory process involved.

Our approach ensures compliance with the latest regulatory framework, including adherence to quality management systems, risk management principles, and essential principles of safety and performance.

Risk Classification and License Requirements for Class A Devices

According to the CDSCO's risk classification, manual adjustable hospital beds are Class A devices, requiring a manufacturing license under Form MD5 (Application Form MD3) granted by the State Licensing Authority. This process involves obtaining a test license, product testing, documentation, notified body audit, and final license grant.

For more details on medical device classification, refer to our Medical Device Classification guide.

Manufacturing License Process for Manual Adjustable Hospital Beds (MD5 License)

The manufacturing license process for Class A devices such as manual adjustable hospital beds is streamlined but requires careful planning. The steps include:

1. Test License Application (Form MD13): Before the manufacturing license, apply for a test license valid for 12 months. This allows you to manufacture the device for testing purposes.

2. Product Testing: Get the hospital beds tested at government-approved laboratories to confirm compliance with applicable standards. Refer to the Testing Laboratories list for authorized labs.

3. Documentation Preparation: Compile all required documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.

4. Application for Manufacturing License (Form MD3): Submit the application for the MD5 license through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts an audit to verify compliance. Check the list of notified bodies to select an authorized auditor.

6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.

7. Grant of License (Form MD5): Upon satisfactory review, the State Licensing Authority issues the manufacturing license.

Manufacturing License Documents Required

To ensure a smooth application process, prepare the following key documents:

• Company Constitution Documents: Incorporation certificate, memorandum, and articles of association.
• Proof of Ownership or Lease of Premises: Legal documents proving control over the manufacturing site.
• Technical Staff Details: Curriculum vitae and qualifications of personnel responsible for manufacturing.
• Fire NOC and Pollution Control NOC: Certificates from relevant authorities.
• Device Master File (DMF): Detailed information on the design, manufacturing process, and specifications. Our Device Master File guide provides comprehensive insights.
• Plant Master File (PMF): Details of the manufacturing facility. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist: Compliance checklist aligning with Indian regulations.
• Risk Management File: Documentation of risk analysis and mitigation strategies. Learn more about Risk Management.
• Test Reports: Certificates from government-approved labs.
• Labels and Instructions for Use (IFU): Samples demonstrating compliance with labeling requirements.
• Quality Management System (QMS) Documents: ISO 13485 certification and associated SOPs.

Import License Process for Manual Adjustable Hospital Beds (MD15 License)

For importers, obtaining an MD15 license is necessary to legally bring manual adjustable hospital beds into India. The import license is granted by the Central Licensing Authority and involves the following steps:

1. Document Preparation: Collect all required certificates including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, Device Master File, Plant Master File, wholesale license, and company constitution.

2. Application Submission: File the application using Form MD14 via the CDSCO MD Online Portal.

3. Review and Query Resolution: The CDSCO reviews documents and may raise queries.

4. Grant of Import License (Form MD15): Upon successful review, the license is issued.

Note that test licenses are not required for imports.

Import License Documents Required

Key documents for import license applications include:

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license for distribution within India
• Company constitution and registration documents

For detailed guidance, visit our Import License Guide.

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3-4 months total.

  • Test license (MD13): 1.5-2 months
  • Product testing: 2-4 weeks (varies by lab)
  • Audit and application processing: 4-6 weeks

• MD15 Import License: Approximately 5-6 months due to document verification.

Timelines depend on timely submission of complete documentation and prompt resolution of queries.

Government Fees and Costs

For the manual adjustable hospital bed (Class A device), the fee structure for the MD5 manufacturing license is as follows:

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

Import license fees vary by class and number of products. For Class A devices:

• Site fee: $1,000 USD per site
• Product fee: $50 USD per product

Budgeting for notified body audits and testing laboratory fees is essential. These costs vary but typically range between Rs. 50,000 to Rs. 1,50,000 depending on scope.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation.

Solution: Use comprehensive checklists and expert reviews to ensure all documents meet CDSCO standards before submission.

Challenge: Difficulty in choosing an appropriate notified body.

Solution: Consult the official list of notified bodies and select one experienced with Class A devices.

Challenge: Prolonged product testing timelines.

Solution: Engage with government-approved labs early and prioritize testing slots.

Challenge: Managing risk management documentation.

Solution: Follow established risk management frameworks as outlined in our Risk Management guide.

Expert Consultation and Support

Our seasoned regulatory consultants bring 25+ years of experience to help you navigate the complexities of CDSCO licensing. From document preparation to audit readiness and query handling, we offer end-to-end support that accelerates your market entry with confidence.

We have successfully guided over 500 companies in obtaining manufacturing and import licenses for Class A medical devices like manual adjustable hospital beds.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device class using the Medical Device Classification guide.

2. Register on CDSCO MD Online Portal: Create your account and familiarize yourself with the portal interface at the CDSCO MD Online Portal.

3. Initiate Test License Application: Submit Form MD13 for the test license to begin manufacturing for testing.

4. Plan Product Testing: Identify and engage with approved testing laboratories early.

5. Prepare Comprehensive Documentation: Utilize our Device and Plant Master File guides for thorough documentation.

6. Schedule Notified Body Audit: Coordinate audit dates post-testing and documentation readiness.

7. Submit Manufacturing License Application: File Form MD3 for the MD5 license after completing test license and audit.

8. Monitor Application Status: Regularly check the CDSCO portal and respond promptly to queries.

By following these steps with expert guidance, your path to obtaining a CDSCO license for your manual adjustable hospital beds will be efficient and successful.

For personalized assistance, please contact our regulatory consultancy team to leverage our extensive expertise in Indian medical device regulations.