CDSCO License for Intermittent traction system

Comprehensive Guide to CDSCO Licensing for Intermittent Traction Systems (Class B Medical Devices)

Entering the Indian medical device market with your Intermittent Traction System—a Class B physical support device designed to apply controlled cervical or lumbar traction—requires meticulous adherence to the Central Drugs Standard Control Organization (CDSCO) regulatory framework. With over 25 years of regulatory consulting experience and 500+ successful client licenses, we provide you with a detailed roadmap to confidently navigate this process.

Understanding Your Device and Its Regulatory Significance

Your Intermittent Traction System (File No. 29/Misc./03/2020-DC (202), notified on 26.7.2021) is an AC-powered electronic device intended for therapeutic traction by applying pre-set forces via motorized harnesses. Classified as Class B under CDSCO guidelines, it carries a moderate risk profile that necessitates obtaining an MD5 Manufacturing License before Indian market distribution.

Regulatory compliance is not just a formality—it ensures patient safety, product efficacy, and legal market access. Non-compliance risks costly delays, penalties, or product recalls.

CDSCO Regulatory Framework for Class B Devices

Under the Medical Device Rules, 2017, Class B devices like your Intermittent Traction System require a state-level manufacturing license (MD5) issued by the State Licensing Authority. The process integrates the following steps:

• Obtaining a Test License (Form MD13)
• Product testing from CDSCO-approved laboratories
• Submission of comprehensive documentation
• Inspection and audit by a Notified Body
• Resolution of queries by CDSCO authorities
• Final grant of the MD5 license

You must submit all applications through the CDSCO MD Online Portal, ensuring transparency and tracking.

Risk Classification and License Requirements for Your Device

Class B devices represent moderate risk, requiring more stringent controls than Class A but less than Class C or D. The MD5 license process is designed to confirm that your manufacturing site and product meet all quality and safety standards.

Check out the Medical Device Classification guide to confirm your device class and requirements.

Step-by-Step Manufacturing License Process (MD5) for Intermittent Traction Systems

1. Apply for a Test License (Form MD13): Initiate with a test license allowing product testing, which typically takes 1.5 to 2 months.
2. Product Testing: Submit your Intermittent Traction System to a CDSCO-recognized testing laboratory. Refer to the Testing Laboratories list for approved facilities.
3. Document Preparation: Compile required documents including Device Master File, Plant Master File, Risk Management File, and more (details below).
4. Submit MD5 Application (Form MD3): Apply for the manufacturing license through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit will be conducted by a notified body (find the Notified Bodies list here) to verify compliance.
6. Respond to Queries: Promptly address any queries raised by CDSCO or the notified body to avoid prolonged delays.
7. License Grant: Upon satisfying all requirements, the MD5 license will be issued in Form MD5.

Essential Documents Required for MD5 License Application

For your Intermittent Traction System, ensure the following documents are meticulously prepared:

• Company Constitution Documents: Incorporation certificates, partnership deeds, or LLP agreements.
• Proof of Premises Ownership or Lease: Registered sale deed or lease agreement.
• Technical Staff Details: Qualification and experience certificates of responsible personnel.
• Fire Safety and Pollution NOCs: Obtained from respective local authorities.
• Device Master File (DMF): Detailed product description, specifications, and manufacturing process. Our Device Master File guide provides in-depth assistance.
• Plant Master File (PMF): Details of the manufacturing facility and equipment, which can be streamlined using our Plant Master File guide.
• Essential Principles Checklist: Compliance with safety and performance requirements.
• Risk Management File: Comprehensive risk analysis and mitigation strategies. Learn more in our Risk Management guide.
• Test Reports: From CDSCO-approved labs validating safety and efficacy.
• Product Labels and Instructions for Use (IFU): As per regulatory standards.
• Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs.

Import License Process for Intermittent Traction Systems (MD15)

If you plan to import this device, an MD15 license from the Central Licensing Authority is mandatory. The process, spanning approximately 5–6 months, involves:

• Preparing documents including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and wholesale license.
• Submitting application via the CDSCO MD Online Portal.
• Responding to department queries.
• Receiving the MD15 license.

Costs vary by device class; for Class B devices, expect fees around $2000 per site plus$1000 per product.

Refer to our detailed Import License guide for practical insights.

Timelines and Processing Duration

Being proactive and submitting complete documentation can significantly reduce processing times.

Government Fees and Associated Costs

• MD5 License Application Fee: ₹5,000 per application
• Per Product Fee: ₹500
• Testing Fees: Vary by lab; budget approximately ₹50,000 to ₹1,00,000 depending on complexity
• Audit Fees: Included as part of notified body charges; varies, typically ₹50,000 to ₹1,00,000

Investing upfront in quality documentation and testing prevents costly reapplications and delays.

Common Challenges and Practical Solutions

• Incomplete Documentation: Preparing a thorough checklist based on CDSCO requirements and our guides prevents application rejection.
• Delays in Product Testing: Early engagement with notified labs and scheduling tests in advance streamline this step.
• Audit Non-Compliance: Conduct internal audits beforehand and train staff on CDSCO expectations.
• Query Resolution Delays: Assign dedicated regulatory personnel to respond promptly to CDSCO communications.

Expert Consultation and Support

Navigating CDSCO regulations can be complex. Our consultancy has empowered over 500 companies with tailored solutions, from document preparation to audit readiness. Leverage our expertise to:

• Develop compliant Device and Plant Master Files
• Execute comprehensive risk management
• Manage product testing efficiently
• Liaise with CDSCO and notified bodies

Practical Next Steps to Start Your CDSCO License Application

1. Register on the CDSCO MD Online Portal to access application forms and status tracking.
2. Initiate Test License Application (Form MD13) to begin product testing.
3. Engage with a CDSCO-approved testing laboratory early to schedule product testing.
4. Prepare and organize all required documentation using our expert guides.
5. Coordinate with a notified body for the upcoming manufacturing site audit.
6. Maintain clear communication channels with CDSCO for timely query resolution.

Our seasoned regulatory consultants are ready to assist you at every step to ensure your Intermittent Traction System achieves swift and successful CDSCO licensing. Reach out today to transform your regulatory journey into a seamless experience.