CDSCO License for Phacoemulsification system

Comprehensive Guide to CDSCO MD9 License for Phacoemulsification System (Class C Ophthalmic Device)

Phacoemulsification systems are critical ophthalmic devices used in cataract surgery to emulsify and remove the eye's lens through a minimally invasive incision. Classified as Class C under the Indian medical device regulations, these devices require stringent regulatory compliance to ensure safety and efficacy. As regulatory consultants with over 25 years of expertise and having supported 500+ companies in securing CDSCO licenses, we provide you with a detailed, actionable roadmap to obtain your MD9 manufacturing license for this high-risk device.

CDSCO Regulatory Framework for Phacoemulsification Systems

The Central Drugs Standard Control Organization (CDSCO) governs the regulatory approval of medical devices in India. Since the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, phacoemulsification systems are explicitly regulated under the ophthalmology category as Class C devices, reflecting their medium-high risk profile.

Class C devices, including phacoemulsification systems, fall under the Central Licensing Authority's jurisdiction and require an MD9 license to manufacture in India. This license ensures that the manufacturing premises, quality management systems, and product testing meet Indian standards aligned with global best practices.

Risk Classification and License Requirements for Phacoemulsification Systems

Phacoemulsification systems are categorized as Class C owing to their invasive nature and critical role in ocular surgery. This classification mandates the following for manufacturers:

• Obtaining an MD9 Manufacturing License (Application Form MD7) from CDSCO Central Licensing Authority.
• Undergoing rigorous product testing from government-approved laboratories.
• Compliance with essential principles including risk management, device master file, and plant master file documentation.

For detailed classification insights, visit our Medical Device Classification guide.

Manufacturing License Process (MD9) for Phacoemulsification Systems

The MD9 license process is comprehensive and includes multiple steps:

1. Test License Application (Form MD13): The first step involves applying for a test license which allows limited manufacturing for product testing. The test license typically takes 1.5 to 2 months for approval.
2. Product Testing: Samples must be tested at CDSCO-approved laboratories to verify compliance with Indian standards. You can refer to the List of Testing Laboratories authorized for this purpose.
3. Document Preparation: Compile all required technical, quality, and administrative documents.
4. MD9 License Application: Submit the MD9 application (Form MD7) through the CDSCO MD Online Portal.
5. Audit and Inspection: CDSCO inspectors conduct a comprehensive audit of your manufacturing facility and quality management system.
6. Query Resolution: Respond promptly to any queries raised during the audit or application review.
7. License Grant: Upon satisfactory evaluation, CDSCO issues the MD9 license (Form MD9).

Manufacturing License Documents Required for Phacoemulsification Systems

A detailed and accurate dossier is critical for approval. For Class C devices like phacoemulsification systems, the following documents are mandatory:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification of Technical and Management Staff
• Fire and Pollution NOCs
• Device Master File (DMF) – Refer to our Device Master File Guide
• Plant Master File (PMF) – See our Plant Master File Guide
• Essential Principles Compliance Checklist
• Risk Management File aligned with ISO 14971 standards – Learn more about Risk Management
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification

Attention to detail in documentation expedites your application and reduces back-and-forth queries.

Import License Process (MD15) for Phacoemulsification Systems

If you are importing these devices instead of manufacturing, an MD15 import license from the Central Licensing Authority is mandatory. The process involves:

• Preparation of requisite import documents including Free Sale Certificate and ISO certification
• Submission of application on the CDSCO portal
• Resolution of queries
• License grant typically within 5-6 months

For detailed steps, refer to our Import License Guide.

Import License Documents Required

• Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international approvals
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Incorporation Certificate

Timeline and Processing Duration

Obtaining an MD9 license for phacoemulsification systems typically takes 4-5 months, distributed as follows:

Planning and proactive management of each step can reduce delays significantly.

Government Fees and Costs

For Class C devices, the fee structure is as follows:

• Application Fee: Rs. 50,000 per application
• Per Product Fee: Rs. 1,000 per product

Additional costs include testing charges at government-approved labs, notified body audit fees, and any consultancy or documentation preparation costs.

Common Challenges and Solutions

Challenge: Delays in product testing due to limited availability of government-approved labs.

Solution: Early scheduling of testing at authorized facilities and considering backup labs can prevent bottlenecks.

Challenge: Incomplete or inconsistent documentation leading to repeated queries.

Solution: Engage experienced regulatory consultants to prepare and review your Device Master File, Plant Master File, and Risk Management File meticulously.

Challenge: Audit non-conformances related to QMS or premises.

Solution: Conduct internal pre-audit assessments and ensure ISO 13485:2016 compliance before applying.

Challenge: Ambiguity in risk classification or device scope.

Solution: Verify device classification using official CDSCO guidelines or our Medical Device Classification tool.

Expert Consultation and Support

Navigating the MD9 licensing process for Class C devices like phacoemulsification systems can be complex. With our 25+ years of experience, we have successfully guided over 500 manufacturers and importers through CDSCO approvals. Our services include:

• Comprehensive gap analysis and document preparation
• Coordination with notified bodies and CDSCO officials
• Pre-audit training and mock inspections
• Assistance with product testing and risk management implementation

Our expert team ensures your submission is robust, reducing approval times and mitigating risks.

Getting Started with Your CDSCO MD9 License Application

To initiate your journey towards obtaining the MD9 manufacturing license for your phacoemulsification system, follow these practical steps:

1. Register on the CDSCO MD Online Portal: Create an authorized account to access application forms and upload documents.
2. Apply for the Test License (Form MD13): Submit your initial test license application to commence limited manufacturing for testing.
3. Schedule Product Testing: Coordinate with CDSCO-approved testing laboratories early to avoid delays.
4. Prepare Complete Documentation: Assemble your Device Master File, Plant Master File, Risk Management File, and QMS certificates.
5. Submit MD9 Application (Form MD7): After successful testing, submit the comprehensive manufacturing license application.
6. Prepare for Audit: Conduct internal readiness assessments and liaise with notified bodies for the audit.
7. Respond to Queries Promptly: Address all CDSCO and audit-related queries within stipulated timelines.

By following this structured approach and leveraging our proven expertise, you can efficiently navigate the regulatory landscape and bring your phacoemulsification system to the Indian market with full CDSCO compliance.

For detailed guidance on the MD9 license application, refer to our MD9 License Guide.

We invite you to contact our regulatory experts to discuss your specific requirements and receive tailored support through every stage of your CDSCO licensing journey.