CDSCO License for Body arch traction table

Introduction to Body Arch Traction Table and Its Regulatory Importance

The Body Arch Traction Table is a Class A medical device designed to provide physical support by flexing a patient into a reverse supine body arch, helping to relieve back muscle and spine tension. As a low-risk medical device under CDSCO regulations, obtaining the appropriate manufacturing license is crucial to legally market this device in India. With over 25 years of experience and having guided 500+ companies, we understand the nuances of the CDSCO licensing pathway and can help you navigate it efficiently.

CDSCO Regulatory Framework for Body Arch Traction Table

As per the Ministry of Health and Family Welfare’s notification (File No. 29/Misc./03/2020-DC (202), dated 26.7.2021), the Body Arch Traction Table falls under the “Physical Support” category and is classified as a Class A medical device. The regulatory framework mandates obtaining an MD5 manufacturing license from the State Licensing Authority before commercializing this device in India.

Risk Classification and License Requirements for Class A Devices

Class A devices are considered low risk and thus are subject to licensing via the MD5 route. This involves a stepwise process including obtaining a test license (Form MD13), product testing from government-approved laboratories, documentation preparation, audit by a notified body, and finally, license grant by the State Licensing Authority.

For detailed classification criteria, you can visit our Medical Device Classification guide.

Manufacturing License Process (MD5) for Body Arch Traction Table

1. Apply for Test License (Form MD13): Initiate the process by applying for a test license, which typically takes 1.5 to 2 months to be granted.
2. Product Testing: Submit samples to CDSCO-approved laboratories for compliance testing. Refer to the Testing Laboratories list for certified labs.
3. Documentation Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
4. Submit Application for Manufacturing License (Form MD3): File your MD5 application through the CDSCO MD Online Portal after compiling all necessary documents and test reports.
5. Audit by Notified Body: The notified body conducts a plant audit. Check the list of notified bodies to select your auditor.
6. Resolve Queries: Address any queries raised by the licensing authority or notified body promptly.
7. License Grant (Form MD5): Upon successful audit and document verification, the manufacturing license is issued.

For an in-depth step-by-step breakdown, explore our MD5 License Guide.

Manufacturing License Documents Required for MD5

To ensure a smooth application process, prepare the following:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Documents
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facility and quality controls (Plant Master File Guide)
• Essential Principles Checklist complying with Indian Medical Device Rules
• Risk Management File specific to the Body Arch Traction Table (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions For Use (IFU)
• Quality Management System (QMS) Documents (typically ISO 13485:2016 compliant)

Import License Process (MD15) for Body Arch Traction Table

If you plan to import the Body Arch Traction Table into India, an MD15 import license from the Central Licensing Authority is mandatory. The process includes:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, and CE Certificate
• Application submission via Form MD14 through the CDSCO MD Online Portal
• Department review and query resolution
• License grant on Form MD15

The import license timeline generally spans 5-6 months. For comprehensive guidance, refer to our Import License Guide.

Timeline and Processing Duration for MD5 License

The total timeframe to obtain an MD5 manufacturing license for the Body Arch Traction Table is approximately 3 to 4 months, detailed as follows:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 2 to 3 weeks
• Documentation and Application Preparation: 2 to 3 weeks
• Notified Body Audit and Inspection: 3 to 4 weeks
• Query Resolution and Final Approval: 1 to 2 weeks

Proactive preparation and timely response can help you stay within these timelines.

Government Fees and Costs for MD5 Licensing

• Application Fee: Rs. 5,000 per application
• Product Fee: Rs. 500 per product (for Body Arch Traction Table, this applies per variant if any)

Additional costs to budget for include:

• Testing laboratory fees (varies by lab and tests required)
• Notified body audit charges (dependent on auditor)
• Consultant fees if you engage professional support

Common Challenges and Solutions

Challenge 1: Incomplete Documentation Many applicants face delays due to missing or inadequate technical files. Solution: Use detailed checklists and templates, such as those provided in our Device and Plant Master File guides, to ensure completeness.

Challenge 2: Delays in Product Testing Testing backlogs can impact timelines. Solution: Schedule sample submissions early and choose labs with shorter turnaround times from the CDSCO-approved Testing Laboratories.

Challenge 3: Audit Non-Compliance Audit failures often stem from inadequate QMS implementation. Solution: Implement ISO 13485:2016 standards rigorously and conduct internal audits before the notified body visit.

Expert Consultation and Support

With two and a half decades of regulatory consulting experience, we have successfully assisted over 500 companies in securing their CDSCO licenses for Class A devices like the Body Arch Traction Table. Our tailored services include:

• Gap analysis and document preparation
• Liaison with CDSCO and notified bodies
• Pre-audit readiness assessments
• Post-audit query resolution

Engaging expert consultants can significantly reduce your regulatory burden and accelerate time-to-market.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class A status based on intended use.
2. Set Up Your QMS: Align processes with ISO 13485:2016.
3. Prepare Device and Plant Master Files: Utilize our comprehensive guides to create robust documentation.
4. Apply for Test License (Form MD13): Submit your application through the CDSCO MD Online Portal.
5. Coordinate Product Testing: Select a CDSCO-approved lab and submit samples promptly.
6. Compile Complete Application for MD5 License (Form MD3): Include all required documents and test reports.
7. Schedule and Prepare for Notified Body Audit: Choose an auditor from the Notified Bodies List and ensure compliance.
8. Respond to Queries Promptly: Maintain open communication with authorities.

By following these concrete steps and leveraging professional expertise, manufacturers can efficiently gain their CDSCO MD5 license for the Body Arch Traction Table and confidently enter the Indian medical device market.