CDSCO License for Total ossicular replacement prosthesis

Comprehensive Guide to CDSCO Licensing for Total Ossicular Replacement Prosthesis (Class D Medical Device)

As a regulatory consultancy with over 25 years of experience and having assisted more than 500 companies in obtaining CDSCO licenses, we recognize the critical importance of navigating India’s regulatory framework efficiently for high-risk medical devices like the Total Ossicular Replacement Prosthesis (TORP). This device, classified under Class D as an internal prosthetic replacement intended for reconstructing ossicular chain segments, demands meticulous compliance with CDSCO regulations to ensure patient safety and market access.

Understanding the CDSCO Regulatory Framework for Total Ossicular Replacement Prosthesis

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. Given the Total Ossicular Replacement Prosthesis is a Class D device, it falls under the highest risk category requiring central licensing authority approval. The notified device falls under the notification number 29/Misc/3/2017-DC (292) dated 06.06.2018.

This classification entails a stringent regulatory process overseen by CDSCO’s Central Licensing Authority, ensuring the device meets all safety, efficacy, and quality requirements before commercialization in India.

Risk Classification and License Requirements for Class D Devices

Class D devices are life-supporting or life-sustaining devices with significant risk potential if malfunctioned. The Total Ossicular Replacement Prosthesis, being an implantable internal prosthetic replacement facilitating sound conduction, is rightly classified as Class D.

For such devices, obtaining an MD9 manufacturing license is mandatory. This license is issued by the Central Licensing Authority and involves a rigorous process including testing, documentation, audits, and compliance verification.

Step-by-Step MD9 Manufacturing License Process for Total Ossicular Replacement Prosthesis

The MD9 license application process for Class D devices generally spans 4-5 months and involves the following sequential steps:

1. Test License (Form MD13) Application:
   • Before applying for the manufacturing license, manufacturers must obtain a test license for the device.
   • Processing time: approximately 1.5-2 months.
2. Product Testing:
   • The device must be tested at CDSCO-approved government laboratories to validate safety and performance.
   • Refer to the Testing Laboratories for the list of authorized labs.
3. Document Preparation:
   • Compilation of comprehensive technical files including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.
4. Application Submission (Form MD7):
   • Submit through the CDSCO MD Online Portal.
5. Audit by CDSCO Inspectors:
   • On-site audit to verify manufacturing compliance and QMS implementation.
6. Resolution of Queries:
   • Address any observations or deficiencies raised during audit or application review.
7. Grant of Manufacturing License (Form MD9):
   • Upon successful compliance, CDSCO will issue the MD9 license.

Essential Documents Required for MD9 License Application

To ensure a smooth application process, manufacturers must prepare and submit the following documents:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, design, manufacturing process, and validation data. Our Device Master File guide offers practical tips on compiling this critical document.
• Plant Master File (PMF): Facility description, equipment, and quality management system overview. Visit our Plant Master File Guide for a stepwise approach.
• Essential Principles Checklist confirming compliance with CDSCO’s safety and performance requirements
• Risk Management File, including hazard analysis and mitigation strategies. Learn more from our Risk Management resource.
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, ideally ISO 13485:2016 certification

Import License Process (MD15) for Total Ossicular Replacement Prosthesis

Importers of this Class D device must apply for an MD15 import license via the Central Licensing Authority, which takes approximately 5-6 months. Unlike manufacturing, no test license is required, but documentation must be comprehensive.

Required documents include:

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

The application is submitted on the CDSCO MD Online Portal. Fees for Class D devices are typically INR 3,000 USD per site plus INR 1,500 USD per product.

Timeline and Processing Duration

For imports (MD15), total processing takes 5-6 months.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application Fee: INR 50,000
  • Per Product Fee: INR 1,000

• MD15 Import License:

  • Site Fee: USD 3,000
  • Product Fee: USD 1,500

Note: Additional costs include fees for product testing, audit-related expenses, and documentation preparation.

Common Challenges and Practical Solutions

• Delayed Testing Results: Collaborate with CDSCO-approved labs early and schedule testing proactively to avoid bottlenecks.
• Incomplete Documentation: Use checklists and expert reviews for Device Master Files and Risk Management Files to ensure completeness.
• Audit Non-compliance: Prepare your manufacturing site and QMS thoroughly; consider mock audits with notified bodies listed on the Notified Bodies List.
• Query Resolution Delays: Respond promptly with detailed explanations and supporting evidence to expedite approvals.

Expert Consultation and Support

Navigating the MD9 licensing pathway for high-risk devices like the Total Ossicular Replacement Prosthesis requires expert guidance. Our consultancy provides end-to-end support—from documentation to audit preparation and liaison with CDSCO—to ensure timely license grant.

We also assist with:

• Preparation of Device and Plant Master Files
• Risk Management implementation
• Coordination with testing laboratories
• Pre-audit readiness assessments

Getting Started with Your CDSCO License Application

1. Assess your device classification and regulatory pathway using resources such as our Medical Device Classification guide.
2. Initiate test license (MD13) application via the CDSCO MD Online Portal.
3. Engage a CDSCO-approved testing laboratory early to book testing slots.
4. Begin compiling essential documentation with technical and regulatory teams.
5. Schedule pre-audit assessment with a notified body to ensure compliance.
6. Submit your MD9 license application (Form MD7) once testing and documentation are complete.

Our team is ready to help you streamline these steps, minimizing delays and maximizing regulatory compliance. Contact us today to kickstart your journey to CDSCO approval for your Total Ossicular Replacement Prosthesis and successfully enter the Indian market.