CDSCO License for Hip joint femoral (hemi-hip) metallic resurfacing  prosthesis

Comprehensive Guide to CDSCO Licensing for Hip Joint Femoral (Hemi-Hip) Metallic Resurfacing Prosthesis

The Hip Joint Femoral (Hemi-Hip) Metallic Resurfacing Prosthesis is a high-risk Class D orthopaedic implant designed to replace a portion of the hip joint, offering an advanced solution for patients requiring durable joint reconstruction. Given its invasive and implantable nature, strict regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) in India is mandatory before manufacturing or importing this device.

With over 25 years of experience and having assisted 500+ medical device companies, we provide an in-depth walkthrough of the CDSCO regulatory framework, licensing process, timelines, costs, and documentation requirements tailored specifically for manufacturers and importers of this device.

CDSCO Regulatory Framework for Orthopaedic Implants (Class D Devices)

The CDSCO classifies medical devices based on risk levels ranging from Class A (lowest risk) to Class D (highest risk). The Hip Joint Femoral Metallic Resurfacing Prosthesis falls under Class D due to its implantable nature and critical impact on patient health.

Per CDSCO Notification 29/Misc/3/2017-DC (292) dated 06.06.2018, Class D devices require stringent oversight by the Central Licensing Authority, which oversees both manufacturing and import licensing.

Understanding these regulations ensures manufacturers and importers meet all safety, quality, and efficacy standards before market entry.

Risk Classification and License Requirements for Class D Devices

Class D devices like the hemi-hip prosthesis are considered high risk because they are implanted and remain in the body for long durations. Consequently, the CDSCO mandates:

• Manufacturing License: MD9 License (Application Form MD7) granted by the Central Licensing Authority.
• Import License: MD15 License (Application Form MD14) also issued by the Central Licensing Authority.

Both licenses require rigorous documentation, testing, audits, and compliance with Indian and international standards.

Manufacturing License Process for Class D Orthopaedic Implants (MD9 License)

Obtaining an MD9 manufacturing license is a multi-step process taking approximately 4 to 5 months from start to finish:

1. Test License Application (Form MD13): First, you must apply for a test license, allowing sample manufacturing for testing purposes. This phase takes about 1.5 to 2 months.

2. Product Testing: Submit samples to CDSCO-approved testing laboratories to verify compliance with performance and safety standards. Refer to the list of CDSCO Testing Laboratories.

3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, and Risk Management File.

4. License Application Submission: Apply online via the CDSCO MD Online Portal using Form MD7.

5. Audit by CDSCO Inspectors: A detailed audit verifies manufacturing facilities, quality systems, and compliance.

6. Query Resolution: Address any queries raised by the department or auditors promptly.

7. License Grant: Upon satisfactory compliance, the MD9 license is issued.

Manufacturing License Documents Required

• Company Constitution (Incorporation Certificate, MOA, AOA)
• Proof of ownership or lease of manufacturing premises
• Qualification and experience documents of technical staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design, specifications, manufacturing processes (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing site and quality systems (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File compliant with ISO 14971 (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485 certified

Costs

• Government fees: ₹50,000 per application
• ₹1,000 per product included in the license

Import License Process for the Hip Joint Femoral Prosthesis (MD15 License)

Importers of Class D devices must obtain an MD15 license from CDSCO Central Authority. The process typically takes 5 to 6 months due to the thorough evaluation required.

Steps include:

1. Document Preparation: Gather all mandatory documents including the manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, and CE certificates.

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

3. Query Resolution: Respond to any department queries to ensure smooth processing.

4. Grant of MD15 License: Once approved, the importer can legally bring the device into the Indian market.

Import License Documents Required

• Valid foreign manufacturing license
• Free Sale Certificate from manufacturer’s country
• ISO 13485:2016 certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License for importers
• Company Constitution documents

Import License Fees

• For Class D devices: ₹3,000,000 per site (approx. $40,000 USD) and ₹1,500,000 per product (approx.$20,000 USD)

Note: Fees may vary with currency fluctuations; confirm current rates during application.

Timeline and Processing Duration Summary

Common Challenges and Practical Solutions

• Delayed Test Reports: Coordinate early with CDSCO-approved labs and submit samples promptly to avoid bottlenecks.

• Incomplete Documentation: Use detailed checklists and expert consultants to ensure all required documents like DMF, PMF, and Risk Management Files are comprehensive and up to date.

• Audit Non-Compliance: Prepare your facility according to audit guidelines; conduct internal mock audits to identify gaps.

• Query Response Delays: Assign dedicated regulatory personnel to monitor application status and respond swiftly.

• Fee Payment Issues: Verify payment methods and ensure timely submission to prevent processing delays.

Expert Consultation and Support

Navigating CDSCO regulatory pathways for Class D orthopaedic implants such as the Hip Joint Femoral Prosthesis demands experience and precision. Our team has successfully guided over 500 companies through this complex process, offering:

• Customized regulatory strategy
• Comprehensive document preparation support
• Coordination with notified bodies and CDSCO inspectors
• Training on compliance and quality management
• Post-approval support for renewals and variations

Engage with us early in your project to streamline your CDSCO licensing journey and reduce time-to-market.

Getting Started with Your CDSCO License Application

1. Classify Your Device: Confirm classification using the Medical Device Classification resource.

2. Prepare Test License Application: Initiate the MD13 test license application via the CDSCO MD Online Portal.

3. Identify Approved Testing Labs: Select appropriate testing laboratories from the CDSCO Testing Laboratories list.

4. Develop Required Documentation: Assemble the Device Master File, Plant Master File, Risk Management File, and QMS documentation with expert assistance.

5. Submit Manufacturing License Application: Once testing is complete, apply for the MD9 license using Form MD7.

6. Prepare for and Facilitate Audits: Ensure your manufacturing site is audit-ready by conducting pre-audit assessments.

7. Plan for Import Licensing: If importing, simultaneously prepare documentation for the MD15 license application.

By following these concrete steps, manufacturers and importers can efficiently navigate CDSCO licensing, ensuring compliant market entry for the Hip Joint Femoral Metallic Resurfacing Prosthesis.

For detailed consulting or assistance throughout the CDSCO license application, contact our expert regulatory team today.