CDSCO License for X- ray marker for strut

Introduction: X-Ray Marker for Strut and Regulatory Importance

The X-ray marker for strut is a specialized Class A medical device used in six-axis correction apparatus with software, primarily falling under the category of general hospital or orthopaedic instruments. This device plays a crucial role in precise imaging and correction in orthopedic treatments. Given its clinical importance and patient safety implications, obtaining a CDSCO license is mandatory before manufacturing or marketing this device in India.

Navigating the CDSCO regulatory framework can be complex, but with over 25 years of experience and assisting 500+ companies, we provide you with clear, actionable steps to streamline your licensing process.

CDSCO Regulatory Framework for X-Ray Markers

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Your X-ray marker for strut falls under Notification 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022, classifying it as a Class A device due to its low risk profile.

Understanding this classification is critical because it determines the licensing pathway, authority involved, and documentation required.

Risk Classification and License Requirements for Class A Devices

Class A devices are considered low-risk and are regulated at the State level. For your X-ray marker, this means obtaining the MD5 manufacturing license using Application Form MD3. The process involves initial testing, documentation, audit, and final approval by the State Licensing Authority.

You can verify the classification and applicable rules on the Medical Device Classification resource.

Manufacturing License Process for MD5 (Class A Devices)

The MD5 license process is detailed but manageable when approached methodically:

1. Apply for Test License (Form MD13): This license allows you to conduct necessary product testing at government-approved labs. It usually takes 1.5 to 2 months to obtain.
2. Product Testing: Get your X-ray marker tested at labs listed by CDSCO, such as those found on the Testing Laboratories list.
3. Document Preparation: Compile all essential documents, including Device Master File and Plant Master File.
4. Submit Manufacturing License Application (Form MD3): Apply through the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body from the Notified Bodies List will conduct an on-site audit.
6. Resolution of Queries: Address any queries raised by the department or auditors promptly.
7. Grant of License (Form MD5): Upon successful compliance, your manufacturing license is granted.

This entire process typically takes 3 to 4 months.

Manufacturing License Documents Required for X-Ray Marker

For your X-ray marker device, ensure you prepare and submit the following:

• Company Constitution Documents: Proof of legal business entity
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details: Qualifications and experience
• Fire NOC & Pollution Control NOC
• Device Master File (DMF): Detailed design, specifications, and manufacturing process (Device Master File guide)
• Plant Master File (PMF): Manufacturing environment, equipment details (Plant Master File guide)
• Essential Principles Checklist: Compliance with safety and performance
• Risk Management File: Risk analysis and mitigation strategies (Risk Management resource)
• Test Reports: From CDSCO-approved labs
• Labels and Instructions for Use (IFU): Accurate, compliant labeling
• Quality Management System (QMS) Documents: ISO 13485:2016 certification or equivalent

Import License Process (MD15) for X-Ray Marker

While your device is Class A and primarily requires an MD5 manufacturing license, importers wishing to bring this device into India must obtain an MD15 import license from the Central Licensing Authority.

The process includes comprehensive document submission such as manufacturing license, free sale certificate, ISO and CE certificates, and more, with a processing time of approximately 5 to 6 months.

For detailed guidance, refer to our Import License guide.

Import License Documents Required

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

Timeline and Processing Duration

These timelines may vary depending on completeness of documentation and audit scheduling.

Government Fees and Costs

For your Class A X-ray marker device, the government fees are as follows:

• Test License (MD13): Rs. 5000 approximately
• MD5 Manufacturing License Application Fee: Rs. 5000 per application
• Product Fee: Rs. 500 per product
• Audit Fees: Paid to notified body separately as per their charges

Budget for additional costs such as testing laboratory fees and consultancy services.

Common Challenges and Practical Solutions

• Incomplete Documentation: Many applicants overlook critical files like Risk Management or Plant Master Files. Use our detailed checklists to avoid missing documents.
• Delayed Testing: Government labs can have backlogs; consider early booking and parallel preparation of documents.
• Audit Non-Compliance: Pre-audit internal inspections and training for staff can mitigate surprises.
• Query Resolution Delays: Prompt and clear responses improve processing speed.

By anticipating these challenges, you can significantly reduce overall processing time.

Expert Consultation and Support

With decades of experience and over 500 successful licenses, we offer tailored consultancy to guide you through every step—from document preparation to audit readiness. Our expertise ensures compliance with the latest notification dated 16.03.2022.

Engage with us early to benefit from practical insights and avoid common pitfalls.

Getting Started with Your CDSCO License Application

1. Assess your device against CDSCO classification to confirm Class A status.
2. Register and submit your initial application for Test License (MD13) via the CDSCO MD Online Portal.
3. Coordinate product testing at an approved laboratory.
4. Prepare comprehensive documentation following our guides on Device and Plant Master Files.
5. Apply for the MD5 manufacturing license (Form MD3) online.
6. Schedule and prepare for the notified body audit.
7. Respond to any queries diligently and await license grant.

By following these steps diligently, you position your X-ray marker for strut device for timely and compliant market entry in India.

For personalized support, do not hesitate to reach out to our expert team who can streamline your CDSCO licensing journey efficiently.