CDSCO License for Nonpowered flotation therapy mattress.

Comprehensive Guide to CDSCO Licensing for Nonpowered Flotation Therapy Mattress (Class A Medical Device)

At our consultancy, with over 25 years of experience and having assisted more than 500 companies, we understand the nuances involved in navigating the CDSCO licensing process for medical devices like the Nonpowered Flotation Therapy Mattress. This specialized mattress, designed to prevent and treat decubitus ulcers (bed sores) through nonpowered flotation technology, falls under the Class A risk category according to the CDSCO classification.

Understanding Your Device: Nonpowered Flotation Therapy Mattress

This mattress is classified under General Hospital or Orthopaedic Instruments, notified under 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022. It contains air, fluid, or other materials to redistribute pressure and facilitate healing without the use of powered components, making it a low-risk medical device.

CDSCO Regulatory Framework for Nonpowered Flotation Therapy Mattress

As a Class A device, the regulatory pathway involves obtaining an MD5 manufacturing license issued by the State Licensing Authority. This license ensures that your manufacturing practices comply with the Medical Device Rules (MDR), 2017, and that the device meets safety and efficacy standards.

Risk Classification and License Requirements

Class A devices are considered low risk and require:

• Test License (Form MD13): Before manufacturing, a test license is mandatory to allow testing of the device.
• Manufacturing License (MD5, Form MD3): Final license for manufacturing after successful testing, documentation, and audit.

The entire process typically takes about 3-4 months, which includes testing, audit, and processing time.

Step-by-Step Manufacturing License Process for MD5 (Class A Devices)

1. Apply for Test License (Form MD13):

   • Submit your application through the CDSCO MD Online Portal.
   • Processing time: Approximately 1.5 to 2 months.

2. Product Testing:

   • Get your nonpowered flotation therapy mattress tested at government-approved labs listed on the CDSCO portal (Testing Laboratories List).
   • Testing validates safety and compliance with essential principles.

3. Preparation of Technical Documentation:

   • Prepare the Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documentation.
   • Our Device Master File Guide and Plant Master File Guide provide detailed insights.

4. Application for Manufacturing License (Form MD3):

   • Submit the complete application with all required documents via the CDSCO MD Online Portal.

5. Audit by Notified Body:

   • The State Licensing Authority schedules an audit by an approved notified body.
   • Check the List of Notified Bodies to select an auditor.

6. Resolution of Queries:

   • Address any clarifications or deficiencies raised by the department or notified body promptly.

7. Grant of MD5 License:

   • Upon successful audit and document verification, the license is granted using Form MD5.

Essential Documents Required for MD5 License Application

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details of Technical Staff with qualifications
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) and Plant Master File (PMF)
• Essential Principles Checklist confirming compliance
• Risk Management File demonstrating hazard analysis and mitigation
• Test Reports from Government Approved Laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (e.g., ISO 13485 certification)

Import License Process for Nonpowered Flotation Therapy Mattress (If Applicable)

If you are an importer, the device falls under Class A and requires an MD15 import license issued by the Central Licensing Authority.

• Application: Submit Form MD14 with all requisite documents through the CDSCO MD Online Portal.

• Documents Required:

  • Valid Manufacturing License from the country of origin
  • Free Sale Certificate
  • ISO 13485:2016 Certificate
  • CE Certificate (if applicable)
  • Device Master File and Plant Master File
  • Wholesale License
  • Company Constitution

• Processing Time: Approximately 5-6 months

• Government Fees: $1000 per site and$50 per product

For a detailed walkthrough, refer to our Import License Guide.

Timeline and Processing Duration

Government Fees and Costs

• Test License Application Fee: Included in manufacturing license process
• MD5 Manufacturing License Fees:
  • Rs 5,000 per application
  • Rs 500 per product
• Additional Costs: Fees for notified body audit and testing laboratory charges vary; budget around Rs 50,000 - 1,00,000 depending on scope and number of products.

Common Challenges and Practical Solutions

Expert Consultation and Support

Our team offers end-to-end support from initial documentation preparation to audit readiness and post-license compliance. With extensive experience in Class A device approvals, we streamline the process, minimize delays, and ensure adherence to all regulatory requirements.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm that your nonpowered flotation therapy mattress is classified as Class A.
2. Gather Preliminary Documents: Compile company certificates, premises proofs, and technical staff details.
3. Register on CDSCO MD Online Portal: Create your account at CDSCO MD Online Portal.
4. Engage a Testing Laboratory: Contact government-approved labs early to schedule product testing.
5. Prepare Device and Plant Master Files: Leverage our Device Master File Guide and Plant Master File Guide for comprehensive documentation.
6. Submit Test License Application: Apply for Form MD13 and await approval before commencing manufacturing trials.
7. Plan for Audit: Identify notified bodies and schedule audits post-testing phase.

By following these pragmatic steps and leveraging our expertise, manufacturers and importers can confidently navigate the regulatory landscape and bring their nonpowered flotation therapy mattresses to the Indian market efficiently.

For personalized assistance, feel free to contact us and benefit from our proven track record in CDSCO licensing success for Class A medical devices.