CDSCO License for Visual chart

Introduction to Visual Chart and Regulatory Importance

The Visual Chart, commonly known as the Snellen chart, is a fundamental ophthalmic device used to assess visual acuity. Classified under Class A medical devices by CDSCO, it falls within the lowest risk category but still requires strict regulatory compliance to ensure patient safety and product efficacy. Our 25+ years of expertise guiding 500+ companies through the CDSCO licensing process uniquely positions us to assist manufacturers and importers in navigating the complex regulatory landscape for ophthalmic devices like Visual Charts.

CDSCO Regulatory Framework for Visual Charts

Visual Charts are regulated under the Ministry of Health and Family Welfare through the Central Drugs Standard Control Organization (CDSCO). As per the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, Visual Charts are classified as Class A devices in India. This classification dictates the licensing pathway, quality requirements, and compliance processes necessary for market entry.

Risk Classification and License Requirements for Visual Charts

Class A devices are considered low risk and include devices like the Visual Chart used in ophthalmology for visual testing. Manufacturers of Class A devices must obtain the MD5 manufacturing license, issued by the State Licensing Authority. The process involves obtaining a Test License first (Form MD13), conducting product testing at CDSCO-approved laboratories, and undergoing an audit by a notified body.

Manufacturing License Process (MD5) for Visual Charts

The manufacturing license for Class A Visual Charts follows a structured process:

1. Test License Application (Form MD13): Required before manufacturing and testing. Processing time is approximately 1.5 to 2 months.
2. Product Testing: Conduct tests at CDSCO-approved laboratories to verify compliance with applicable standards.
3. Documentation Preparation: Compile all necessary documents including Device Master File and Plant Master File.
4. License Application (Form MD3): Submit for MD5 license through the CDSCO MD Online Portal.
5. Audit by Notified Body: An on-site audit to verify manufacturing processes and quality systems.
6. Query Resolution: Address any queries raised by the department or notified body.
7. Grant of MD5 License (Form MD5): Final approval allowing commercial manufacturing.

This end-to-end process typically takes 3 to 4 months.

Manufacturing License Documents Required for Visual Chart

To ensure a smooth application, prepare the following documents:

• Company Constitution and Incorporation Documents
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Records
• Fire NOC and Pollution Control Board Clearance
• Device Master File detailing design, specifications, and intended use (Device Master File Guide)
• Plant Master File describing the manufacturing facility (Plant Master File Guide)
• Essential Principles Checklist aligned with CDSCO standards
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Visual Charts

For importers intending to bring Visual Charts into India, an MD15 license granted by the Central Licensing Authority is mandatory. This process does not require a Test License but necessitates comprehensive documentation including the foreign manufacturer’s ISO 13485 certification and Free Sale Certificate.

The stepwise process includes:

1. Document compilation as per CDSCO requirements.
2. Submission of application using Form MD14 via the CDSCO MD Online Portal.
3. Departmental review and query resolution.
4. Grant of MD15 import license.

The import license process generally takes 5 to 6 months.

Import License Documents Required for Visual Charts

Prepare the following documents:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate proving marketing approval abroad
• ISO 13485:2016 certification of the manufacturer
• CE Certificate, if applicable
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution and Registration Proof

Timeline and Processing Duration

For imports, expect approximately 5 to 6 months from application to license grant.

Government Fees and Costs

• MD5 Manufacturing License: Rs. 5,000 per application plus Rs. 500 per product.
• Test License (MD13): Included in overall fees.
• Import License (MD15): For Class A devices, approximately $1000 (~Rs. 75,000) per site and$50 (~Rs. 3,750) per product.

Note that fees are subject to change; always verify current rates on the CDSCO MD Online Portal.

Common Challenges and Solutions

• Incomplete Documentation: One of the most frequent causes of delay. Solution: Use our comprehensive checklists and templates to ensure every document is complete and compliant.
• Delayed Product Testing: Limited slots in government-approved labs can cause bottlenecks. Solution: Book testing appointments early and consider multiple approved labs from the Testing Laboratories list.
• Audit Non-Compliance: Audit failures due to inadequate quality management systems or facility issues. Solution: Conduct pre-audit internal reviews and utilize notified bodies from the Notified Bodies List for consultation.
• Query Resolution Delays: Slow responses to department queries can stall approvals. Solution: Maintain a dedicated regulatory liaison to promptly address all queries.

Expert Consultation and Support

With over 25 years of experience and 500+ successful CDSCO license applications, our regulatory experts provide end-to-end support including:

• Regulatory strategy tailored for ophthalmic Visual Charts
• Document preparation and review
• Coordination with notified bodies and testing labs
• Training for audit readiness
• Post-license compliance and renewal assistance

Engage with us early in your product development cycle to avoid costly pitfalls.

Getting Started with Your CDSCO License Application for Visual Charts

1. Assess Your Device Classification: Confirm Class A status via the official Medical Device Classification.
2. Register on CDSCO MD Online Portal: Create an account on the CDSCO MD Online Portal to access application forms and submit documentation.
3. Prepare Test License Application (MD13): Compile initial documents and apply to start manufacturing and testing.
4. Select CDSCO-Approved Testing Laboratory: Schedule product testing at an approved lab.
5. Develop Required Files: Prepare Device Master File, Plant Master File, and Risk Management File using our detailed guides.
6. Coordinate Audit Scheduling: Engage a notified body early to plan the audit.
7. Submit MD5 License Application: After successful testing and documentation readiness, apply using Form MD3.
8. Monitor and Respond Promptly: Track application status and respond quickly to any queries from CDSCO.

By following these practical steps and leveraging expert support, manufacturers and importers can confidently navigate the regulatory process for Visual Charts and achieve timely market access in India.