CDSCO License for Anomaloscope

Comprehensive Guide to CDSCO Licensing for Anomaloscope – Class A Ophthalmic Device

As seasoned regulatory consultants with over 25 years and having assisted 500+ companies in securing CDSCO licenses, we understand the complexities manufacturers and importers face. This guide specifically focuses on the Anomaloscope, a Class A ophthalmic instrument designed to diagnose red/green color vision defects, detailing the regulatory pathway under CDSCO's framework.

Introduction: Understanding the Anomaloscope and Its Regulatory Importance

The Anomaloscope is an essential diagnostic ophthalmic device used to evaluate color vision deficiencies, particularly red/green color blindness. Classified as a low-risk (Class A) medical device under Indian regulations, it falls under the ophthalmology category. Despite its lower risk classification, market access still mandates strict adherence to CDSCO licensing to ensure patient safety and compliance with Indian regulations, including notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.

Obtaining the appropriate CDSCO license is critical for manufacturers aiming to legally market and distribute the Anomaloscope in India. Non-compliance can result in penalties, product recalls, or denial of market entry.

CDSCO Regulatory Framework for Ophthalmic Devices Like Anomaloscope

India’s Central Drugs Standard Control Organization (CDSCO) oversees medical device regulation, including manufacturing and import licensing. The framework categorizes devices into four classes (A, B, C, D) based on risk, with Class A being the lowest risk category. The Anomaloscope, due to its diagnostic role with minimal risk, is classified as Class A.

The regulatory pathway for Class A devices involves the State Licensing Authority issuing the manufacturing license (MD5 license). Importers must obtain an MD15 import license from the Central Licensing Authority.

Risk Classification and License Requirements for Anomaloscope

• Risk Class: A (Low risk)
• Category: Ophthalmology
• License Type: MD5 Manufacturing License (for domestic manufacturing)
• Regulatory Authority: State Licensing Authority

Class A devices require:

• A Test License (Form MD13) initially for product testing
• Product testing in CDSCO-approved laboratories
• Submission of technical and quality documentation
• Audit by a notified body
• Final grant of manufacturing license (Form MD5)

Manufacturing License Process (MD5) for Anomaloscope

The MD5 license application is a multi-step process:

1. Test License Application (Form MD13): Apply for a test license to legally manufacture the device samples for testing. This is the first step and takes approximately 6-8 weeks.

2. Product Testing: Get the Anomaloscope tested at CDSCO-approved labs to verify compliance with essential principles and safety standards. Typical testing duration is 4-6 weeks.

3. Documentation Preparation: Compile the Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, test reports, labels, instructions for use (IFU), and quality management system (QMS) documents.

4. License Application (Form MD3): Submit the application for manufacturing license on the CDSCO MD Online Portal after successful testing.

5. Audit by Notified Body: Coordinate with a notified body from the CDSCO Notified Bodies List for a mandatory audit of manufacturing premises and quality systems.

6. Query Resolution: Address any observations or queries raised by the state licensing authority or notified body promptly.

7. Grant of License (Form MD5): Upon satisfactory compliance, the State Licensing Authority issues the manufacturing license.

Manufacturing License Documents Required for Anomaloscope

For the MD5 license application, you must prepare and submit the following documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Deed of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (Learn how to create a Device Master File)
• Plant Master File (PMF) describing manufacturing facilities (PMF Guide)
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File, showcasing hazard analysis and mitigation (Risk Management Guide)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, typically ISO 13485 certified

Import License Process (MD15) for Anomaloscope

If you intend to import the Anomaloscope into India, you must obtain the MD15 import license from CDSCO Central Licensing Authority. The process includes:

1. Document Preparation: Gather all necessary certificates including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and company constitution.

2. License Application (Form MD14): Submit the application via the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any queries raised by CDSCO officials.

4. Grant of License (Form MD15): Receive the import license allowing legal importation.

For Class A devices like Anomaloscope, the government fees are approximately $1000 per site plus$50 per product.

Refer to our detailed Import License Guide for stepwise assistance.

Timeline and Processing Duration

Total Duration: Approximately 3-4 months from test license application to grant of MD5 license.

Government Fees and Costs

• Test License Fee: Typically included in application costs
• MD5 License Fee: Rs. 5,000 per application + Rs. 500 per product
• Notified Body Audit Fees: Variable, depending on audit scope and notified body
• Testing Fees: Charged by CDSCO-approved labs based on test parameters

Common Challenges and Solutions

• Delayed Testing Results: Plan testing schedules in advance and choose laboratories with proven turnaround times.
• Incomplete Documentation: Use checklists and expert consultations to ensure all documents (DMF, PMF, Risk Management) meet CDSCO requirements.
• Audit Non-Compliance: Conduct internal audits to prepare for notified body inspections and address gaps proactively.
• Query Resolution Delays: Respond promptly and comprehensively to all CDSCO queries to avoid processing delays.

Expert Consultation and Support

Navigating CDSCO licensing can be daunting. Our team has supported over 500 companies in achieving timely approvals for devices like the Anomaloscope. We offer:

• Comprehensive gap analysis of your documentation
• Assistance with Device and Plant Master File preparation
• Coordination with notified bodies and CDSCO labs
• Guidance through audit and query resolution process

Getting Started with Your CDSCO License Application for Anomaloscope

1. Evaluate Risk Classification: Confirm the Anomaloscope’s Class A status.
2. Prepare Test License Application (Form MD13): Begin gathering required documents and submit via the CDSCO MD Online Portal.
3. Select CDSCO-Approved Testing Laboratory: Choose from the approved list to initiate product testing.
4. Develop Comprehensive Documentation: Start compiling your DMF, PMF, Risk Management File, and QMS documents.
5. Plan for Notified Body Audit: Identify and contact a notified body early using the Notified Bodies List.
6. Engage Expert Consultants: Consider leveraging expert regulatory support to avoid common pitfalls and expedite licensing.

By following this structured approach, manufacturers and importers of the Anomaloscope can confidently navigate India’s regulatory landscape, ensuring compliance and timely market entry.

For personalized assistance or detailed consultation, reach out to our experienced team and benefit from our 25+ years of regulatory expertise.