CDSCO License for Felt tangent screen

Comprehensive Guide to Obtaining CDSCO License for Felt Tangent Screen (Class A Ophthalmology Device)

At our consultancy, with over 25 years of expertise in Indian medical device regulations, we have successfully guided 500+ companies through the Central Drugs Standard Control Organization (CDSCO) licensing process. In this detailed guide, we focus on the Felt Tangent Screen — a Class A ophthalmology device used to assess peripheral visual fields — helping you navigate the regulatory requirements efficiently and compliantly.

Introduction to Felt Tangent Screen and Regulatory Importance

The Felt Tangent Screen is a specialized black tangent screen designed to assess the extent of a patient's peripheral visual field by mapping the visual response to a test object moved from the periphery towards the centre of the screen. As a Class A device under CDSCO classification, it falls into the low-risk category but still requires appropriate licensing to ensure safety, quality, and compliance with Indian regulations.

Regulatory approval by CDSCO is mandatory before manufacturing or importing such devices in India. The notification number Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021, formally recognizes this device under the ophthalmology category, ensuring it adheres to the essential principles of safety and performance.

CDSCO Regulatory Framework for Felt Tangent Screen

The CDSCO framework classifies medical devices into four risk classes (A, B, C, D). Felt Tangent Screen is classified as Class A, which is considered low risk.

For Class A devices, the State Licensing Authority grants the manufacturing license known as the MD5 license. The entire process involves a test license, product testing, document submission, audit by a notified body, and final license issuance.

This structure ensures that even low-risk devices meet stringent quality and safety requirements before entering the Indian market.

Risk Classification and License Requirements for Felt Tangent Screen

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority
• Applicable Forms:
  • Test License: Form MD13
  • Manufacturing License: Form MD3 (application), Form MD5 (license)

Manufacturing License Process (MD5) for Felt Tangent Screen

The MD5 license process for the Felt Tangent Screen involves the following key steps:

1. Obtain Test License (Form MD13): Required before manufacturing/testing. Takes approximately 1.5 to 2 months.
2. Product Testing: Conduct tests at CDSCO-approved government laboratories to ensure compliance with essential principles.
3. Document Preparation: Compile all necessary technical and quality documents, including Device Master File and Plant Master File.
4. Application Submission: Submit application on the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: Engage a CDSCO-recognized notified body for audit. Refer to the list of notified bodies for selection.
6. Resolution of Queries: Address any questions raised by the department or notified body promptly.
7. Grant of License: Upon satisfactory review and audit, CDSCO issues the MD5 license (Form MD5).

Manufacturing License Documents Required for Felt Tangent Screen

To ensure a smooth approval process, prepare the following documentation meticulously:

• Company Constitution Documents (e.g., Incorporation Certificate)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Personnel Qualification & Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) — detailing device design, specifications, and manufacturing processes. Our detailed Device Master File guide can assist in preparation.
• Plant Master File (PMF) — outlining the manufacturing facility's infrastructure and quality systems. Refer to our Plant Master File guide for templates and best practices.
• Essential Principles Checklist — demonstrating compliance with CDSCO essential principles
• Risk Management File — documenting hazard identification and mitigation strategies, per ISO 14971 standards. Learn more about implementing risk management.
• Test Reports from CDSCO-approved labs (see Testing Laboratories)
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485 certification, SOPs, CAPA, etc.)

Import License Process (MD15) for Felt Tangent Screen

While this guide focuses on manufacturing, importers of Felt Tangent Screens must obtain an MD15 import license from the Central Licensing Authority. This process takes approximately 5-6 months and requires:

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certification (if applicable)
• Device and Plant Master Files
• Wholesale License
• Company Constitution

The application is submitted via the CDSCO MD Online Portal using Form MD14.

For a detailed step-by-step import license guide, visit our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License from India
• Company Constitution Documents

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): Included in initial application fees
• MD5 License Application Fee: Rs 5000 per application
• Product Fee: Rs 500 per product (Felt Tangent Screen is a single product)
• Audit Fees: Varies by notified body; typically ranges from Rs 50,000 to Rs 1,00,000. Check notified bodies here.
• Testing Fees: Charged by government-approved labs, approximately Rs 30,000 to Rs 50,000 depending on test scope

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Select government-approved labs with shorter lead times. Plan testing well in advance.

Challenge 2: Incomplete or Improper Documentation

• Solution: Use our comprehensive checklists for Device Master File and Plant Master File to ensure all regulatory elements are covered.

Challenge 3: Notified Body Audit Non-compliance

• Solution: Conduct internal audits and gap assessments before notified body visits. Prepare your QMS and technical file meticulously.

Challenge 4: Query Resolution Delays

• Solution: Assign a dedicated regulatory affairs professional to respond to CDSCO queries promptly and accurately.

Expert Consultation and Support

Our team, with decades of experience and over 500 successful CDSCO license grants, offers tailored consulting services:

• End-to-end license application preparation
• Device Master File and Plant Master File development
• Quality management system implementation
• Mock audits and pre-inspection preparation
• Regulatory strategy and compliance support

We ensure your Felt Tangent Screen application proceeds smoothly, minimizing delays and maximizing compliance.

Getting Started with Your CDSCO License Application for Felt Tangent Screen

1. Register on the CDSCO MD Online Portal: This is your primary platform for all application submissions and correspondence.
2. Initiate Test License Application (Form MD13): Prepare and submit required documents for test license approval.
3. Schedule Product Testing: Coordinate with a CDSCO-approved lab early to avoid bottlenecks.
4. Prepare Documentation: Use our guides for Device Master File and Plant Master File to compile required documents.
5. Identify a Notified Body: Choose a notified body from the official list and schedule your audit.
6. Submit MD5 Application (Form MD3): After test license and testing are complete, file the manufacturing license application.
7. Respond Promptly to Queries: Maintain open communication with CDSCO and the notified body.
8. Receive Your License (Form MD5): Once approved, legally manufacture and market your Felt Tangent Screen in India.

For personalized assistance or to begin your application, contact our expert regulatory team today. We help you turn complex regulatory requirements into a clear, actionable roadmap, ensuring your Felt Tangent Screen reaches the Indian healthcare market without unnecessary delays or compliance risks.