CDSCO License for Keratoprosthesis

Comprehensive Guide to CDSCO Licensing for Keratoprosthesis (Class D Medical Device)

Keratoprosthesis is a highly specialized medical device designed to restore vision by providing a transparent optical pathway through an opacified cornea. Classified under Internal Prosthetic Replacements and falling in the highest risk category—Class D—this device requires rigorous regulatory compliance in India. Given its critical role in ophthalmic surgery and permanent implantation, securing a CDSCO license is essential before manufacturing or importing keratoprosthesis devices into the Indian market.

With over 25 years of regulatory consulting and having successfully supported more than 500 companies, we understand the unique challenges manufacturers and importers face with Class D devices. This guide provides detailed, actionable insights on the CDSCO licensing process for keratoprosthesis, including timelines, costs, document requirements, and practical tips to navigate the complex regulatory landscape efficiently.

CDSCO Regulatory Framework for Keratoprosthesis

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India under the Medical Device Rules, 2017. The keratoprosthesis falls under Class D, the highest risk category due to its invasive nature and permanent implantation inside the human body.

The regulatory framework mandates manufacturers and importers to obtain a Manufacturing License (MD9) or Import License (MD15) respectively, granted by the Central Licensing Authority. The process ensures safety, efficacy, and quality through stringent audits, testing, and documentation.

The device is notified under the gazette notification no. 29/Misc/3/2017-DC (292) dated 06.06.2018, confirming its classification and regulatory oversight.

For a detailed understanding of device risk classification, visit our guide on Medical Device Classification.

Risk Classification and License Requirements for Keratoprosthesis

• Risk Class: D (Highest Risk)
• License Type: MD9 Manufacturing License (Form MD7) for manufacturers
• Authority: Central Licensing Authority (CDSCO Headquarters, New Delhi)
• Scope: Manufacture of Class D internal prosthetic replacements including keratoprosthesis

Given the risk class, the MD9 license process involves detailed testing, comprehensive documentation, and a CDSCO inspection audit to uphold stringent quality and safety standards.

Manufacturing License Process for Keratoprosthesis (MD9 License)

The MD9 license process for Class D devices like keratoprosthesis typically spans 4 to 5 months and follows these key steps:

1. Test License Application (Form MD13): Before full license application, manufacturers must obtain a test license from CDSCO, which takes approximately 1.5 to 2 months.

2. Product Testing: The device must undergo testing at CDSCO-approved government laboratories to verify conformity with prescribed standards. You can find the list of Testing Laboratories here.

3. Preparation of Technical Documentation: This includes the Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.

4. Submission of Manufacturing License Application (Form MD7): Apply through the CDSCO MD Online Portal.

5. CDSCO Inspection Audit: An in-depth audit by CDSCO inspectors ensures compliance with GMP, QMS, and manufacturing standards.

6. Resolution of Queries: Respond promptly to any observations or queries raised by CDSCO or the inspection team.

7. Grant of MD9 License: Upon satisfactory compliance, the license is issued allowing legal manufacture of keratoprosthesis.

For a thorough walkthrough, our MD9 License Guide provides detailed steps.

Manufacturing License Documents Required for Keratoprosthesis

Preparing a complete dossier is critical. The following documents are required:

• Company Constitution (Certificate of Incorporation/Partnership Deed)
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff and Their Qualifications
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed technical specifications, design, and manufacturing process. See our Device Master File Guide.
• Plant Master File (PMF): Information on the manufacturing facility, infrastructure, and quality systems. Refer to our Plant Master File Guide.
• Essential Principles Checklist: Demonstrating compliance with Indian regulatory requirements.
• Risk Management File: Comprehensive risk analysis and mitigation strategies. Learn more about Risk Management.
• Test Reports from government-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents: Including ISO 13485 certification details

Meticulous documentation expedites CDSCO review and prevents avoidable delays.

Import License Process for Keratoprosthesis (MD15 License)

If you intend to import keratoprosthesis devices into India, obtaining an MD15 Import License from CDSCO's Central Licensing Authority is mandatory.

Key steps include:

1. Document Preparation: Compile all required documents, including the manufacturing license from the country of origin.

2. License Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.

3. Queries and Clarifications: Address any queries raised by CDSCO promptly.

4. Grant of MD15 License: License will be issued within approximately 5 to 6 months.

Unlike manufacturing licenses, test licenses are not required for import applications.

Import License Documents Required for Keratoprosthesis

To apply for an MD15 license, ensure the following documents are ready:

• Valid Manufacturing License from the Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or Equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution Documents

The fees vary by risk class and product quantity; more on costs is below.

For a detailed checklist, refer to our Import License Guide.

Timeline and Processing Duration for Keratoprosthesis Licensing

Expect approximately 4 to 5 months from test license initiation to MD9 license grant for manufacturing. Import licensing typically takes 5 to 6 months.

Timely submission of complete documentation and swift responses to CDSCO queries are critical to adhere to these timelines.

Government Fees and Costs for Keratoprosthesis License

• MD9 Manufacturing License Fees:

  • Application Fee: ₹50,000 per application
  • Product Fee: ₹1,000 per product

• MD15 Import License Fees:

  • For Class D devices like keratoprosthesis, fees are approximately $3,000 per site and$1,500 per product.

Additional costs may include:

• Testing fees at government laboratories
• Audit and inspection preparation costs
• Consultancy fees if engaging external experts

Budgeting accurately for these fees upfront avoids surprises during application.

Common Challenges and Solutions in Licensing Keratoprosthesis

Challenge: Delayed test reports due to lab backlogs.

• Solution: Engage early with approved testing labs and schedule tests well in advance.

Challenge: Incomplete technical documentation causing multiple query rounds.

• Solution: Use checklists and expert consultation to prepare comprehensive DMFs, PMFs, and risk files.

Challenge: Non-conformance during CDSCO audit.

• Solution: Conduct internal pre-audit assessments and train staff on GMP and QMS compliance.

Challenge: Long processing times due to slow query resolution.

• Solution: Assign dedicated regulatory personnel to respond promptly and accurately to CDSCO queries.

We have successfully helped clients overcome these hurdles through practical strategies and proactive planning.

Expert Consultation and Support for Keratoprosthesis Licensing

Navigating the MD9 licensing process for high-risk devices like keratoprosthesis can be daunting without specialized expertise. With our extensive experience supporting over 500 medical device companies, we offer tailored solutions including:

• End-to-end application preparation and submission
• Device and plant master file development
• Risk management and essential principles compliance
• Pre-audit readiness and mock inspections
• Liaising with CDSCO and notified bodies

Partnering with seasoned regulatory consultants accelerates approval timelines and ensures compliance, avoiding costly rejections or delays.

Getting Started with Your CDSCO License Application for Keratoprosthesis

Ready to enter the Indian market with your keratoprosthesis device? Here are practical next steps:

1. Assess Device Classification: Confirm your device’s Class D status and applicable licensing requirements.

2. Initiate Test License (MD13) Application: Submit your test license application through the CDSCO MD Online Portal promptly.

3. Engage Government-Approved Testing Labs: Plan and schedule required product testing early.

4. Compile Comprehensive Documentation: Prepare your Device Master File, Plant Master File, Risk Management File, and all mandatory documents.

5. Schedule CDSCO Audit Preparation: Conduct internal reviews and training.

6. Submit Manufacturing License (MD9) Application: Once test license and testing are complete.

7. Respond to CDSCO Queries Promptly: Maintain open communication channels.

Starting early and methodically following these steps improves your chances of a smooth, successful licensing process.

For personalized assistance and detailed guidance tailored to your keratoprosthesis device, contact our regulatory consulting team today.