CDSCO License for Colour-discrimination eye chart

Comprehensive Guide to CDSCO Licensing for Colour-Discrimination Eye Chart (Class A Medical Device)

As a regulatory consulting firm with over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we understand the complexities involved in bringing ophthalmology devices like the Colour-discrimination eye chart to the Indian market. This device, classified under Class A risk, is intended for testing colour vision and falls under the ophthalmology category as per notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.

Navigating the regulatory framework efficiently ensures timely market entry and compliance with Indian laws. Below, we detail the end-to-end licensing process, document requirements, costs, and practical tips tailored specifically for this device.

CDSCO Regulatory Framework for Colour-Discrimination Eye Chart

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, ensuring safety, efficacy, and quality. Colour-discrimination eye charts are medical devices used in ophthalmology for assessing colour vision defects, falling under Class A — the lowest risk category.

Since the notification dated August 9, 2021, this device requires a manufacturing license under Form MD5, issued by the State Licensing Authority. The regulatory pathway involves a test license, product testing, document submission, and audit by a notified body.

Understanding the framework helps manufacturers and importers align their processes with CDSCO’s requirements, preventing delays and costly rejections.

Risk Classification and License Requirements for Colour-Discrimination Eye Chart

• Risk Class: A (Low Risk)
• Applicable License: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority
• Relevant Notification: Fts No. 29/MiscJO3/2020-DC (187), dated 09.08.2021

Class A devices are subject to a relatively streamlined approval process, but manufacturers must still adhere to rigorous documentation, product testing, and quality system standards.

Manufacturing License Process (MD5) for Class A Devices

Obtaining the MD5 license involves several sequential steps:

1. Test License Application (Form MD13): Initially, apply for a test license to manufacture the device for evaluation and testing purposes. This license is mandatory before proceeding to full manufacturing license.

2. Product Testing: Conduct testing of the Colour-discrimination eye chart at CDSCO-approved laboratories to verify compliance with applicable standards.

3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.

4. Application Submission (Form MD3): Submit the MD5 license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: The State Licensing Authority will coordinate with a notified body for an on-site audit of manufacturing premises and QMS. Refer to the list of notified bodies for audit requirements.

6. Resolve Queries: Address any queries or deficiencies identified by the department or notified body in a timely manner.

7. Grant of License: Upon satisfactory review and audit, the State Licensing Authority grants the MD5 license (Form MD5), authorizing manufacture.

For a detailed overview, consult our MD5 License Guide.

Manufacturing License Documents Required for Colour-Discrimination Eye Chart

The following documents are essential for the MD5 license application:

• Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association
• Proof of Ownership/Lease for Manufacturing Premises
• Technical Staff Qualifications and Experience relevant to ophthalmic device manufacturing
• No Objection Certificates (NOCs): Fire safety, pollution control
• Device Master File (DMF): Detailed device design, specifications, intended use, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Description of manufacturing facility, equipment, and processes (Plant Master File Guide)
• Essential Principles Checklist: Compliance with regulatory standards
• Risk Management File: Documented risk analysis and mitigation strategies (Risk Management)
• Test Reports: From CDSCO-approved labs confirming product safety and performance (Testing Laboratories)
• Labels and Instructions for Use (IFU): As per CDSCO labeling requirements
• Quality Management System Documents: ISO 13485 compliant QMS manuals, procedures

Ensuring completeness and accuracy of these documents significantly reduces processing delays.

Import License Process (MD15) - Relevant for Importers

Though this guide primarily focuses on manufacturing licenses, importers of the Colour-discrimination eye chart must apply for an MD15 import license from the Central Licensing Authority.

The process includes:

• Document preparation, including manufacturing license from country of origin
• Certificate of Free Sale
• ISO 13485:2016 certification
• CE Certificate (if applicable)

The license application is submitted via the CDSCO MD Online Portal and typically takes 5-6 months for processing.

For detailed assistance, refer to our Import License Guide.

Timeline and Processing Duration for MD5 License

• Test License (MD13): 1.5 to 2 months
• Product Testing: 3 to 4 weeks (varies with lab workload)
• Document Preparation: Concurrent with testing, approx 2 to 3 weeks
• Application Submission and Audit: 1.5 to 2 months
• Query Resolution: 2 to 4 weeks

Total Estimated Time: Approximately 3 to 4 months from test license application to final license grant.

Planning for contingencies and prompt response to queries can help avoid unnecessary delays.

Government Fees and Costs for MD5 License

• Test License (MD13) Fees: Rs. 5000 (approximate, varies by state)
• MD5 License Application Fees: Rs. 5000 per application
• Product Fees: Rs. 500 per product (for the Colour-discrimination eye chart, this applies once as a single product)

Additional costs may include:

• Testing laboratory fees
• Notified body audit charges
• Consultant fees if external regulatory support is engaged

Budgeting realistically for these expenses is crucial for smooth project execution.

Common Challenges and Solutions

Challenge 1: Incomplete Documentation

• Solution: Utilize detailed checklists and consult our comprehensive guides to ensure all documents are prepared correctly.

Challenge 2: Delays in Product Testing

• Solution: Engage with CDSCO-approved labs early and track testing progress closely.

Challenge 3: Audit Non-conformities

• Solution: Conduct internal audits before official notified body audits to identify and rectify gaps.

Challenge 4: Query Resolution Delays

• Solution: Assign a dedicated regulatory point of contact to swiftly manage communications with CDSCO.

Expert Consultation and Support

Our proven track record with over 500 successful CDSCO license applications enables us to provide tailored support:

• Document preparation and review
• Audit readiness and pre-inspection consultancy
• Application submission and follow-up
• Liaison with CDSCO officials and notified bodies

We help manufacturers and importers minimize risks and accelerate approval timelines.

Getting Started with Your CDSCO License Application for Colour-Discrimination Eye Chart

1. Assess your Device Classification: Confirm your device is Class A under the CDSCO framework.

2. Register on the CDSCO MD Online Portal: This is mandatory for all applications.

3. Apply for Test License (MD13): Begin manufacturing small batches for testing.

4. Coordinate Product Testing: Book slots at CDSCO-approved labs early to avoid bottlenecks.

5. Prepare Complete Documentation: Use our Device Master File and Plant Master File guides to compile accurate dossiers.

6. Submit MD5 License Application (Form MD3): Once test reports are available and documentation is ready.

7. Prepare for Audit: Conduct mock audits and ensure compliance with QMS and regulatory norms.

8. Respond Promptly to Queries: Maintain clear communication with CDSCO and notified bodies.

By following these actionable steps and leveraging expert guidance, you can confidently navigate the CDSCO licensing process and successfully launch your Colour-discrimination eye chart in India’s ophthalmology market.

For further personalized assistance, contact our regulatory experts who specialize in ophthalmic device registrations and compliance.

References and Resources:

• CDSCO MD Online Portal
• List of Notified Bodies
• List of Testing Laboratories
• Device Master File Guide
• Plant Master File Guide
• MD5 License Guide
• Risk Management

We look forward to partnering with you on your regulatory journey to bring innovative ophthalmology devices to the Indian healthcare ecosystem.