CDSCO License for Tachistoscope

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

At our firm, with over 25 years of experience and having successfully supported 500+ companies, we understand the intricacies involved in securing CDSCO licenses for medical devices like the Tachistoscope. This ophthalmic device, designed to flash words or images at varying speeds for diagnostic testing, falls under Class A – the lowest risk category – as per the latest CDSCO notification (Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021).

Navigating the regulatory framework efficiently ensures timely market entry and compliance, which is crucial for manufacturers and importers aiming to establish a presence in India’s thriving ophthalmology segment.

CDSCO Regulatory Framework for Tachistoscope (Class A Ophthalmic Device)

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. The Tachistoscope, categorized under ophthalmic devices, is classified as Class A based on its intended use and risk profile.

Class A devices are subject to licensing by the State Licensing Authority rather than the Central Authority, streamlining the process while maintaining rigorous quality and safety standards.

For detailed understanding, refer to the Medical Device Classification guide which provides clarity on risk classes and regulatory requirements.

Risk Classification and License Requirements for Tachistoscope

• Device Name: Tachistoscope
• Risk Class: Class A
• Category: Ophthalmology
• Regulatory License: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority

Being a Class A device, the Tachistoscope requires an MD5 license, which is the standard manufacturing license for Class A and B devices. The process involves initial test licensing, product testing, documentation, audit, and finally obtaining the manufacturing license.

Manufacturing License Process (MD5) for Tachistoscope

1. Test License Application (Form MD13): Before applying for the MD5 license, manufacturers must obtain a test license. This allows the product to be tested in CDSCO-approved laboratories.
2. Product Testing: Testing must be conducted in government-approved labs to ensure compliance with essential principles and safety standards. A list of Testing Laboratories is available for reference.
3. Documentation Preparation: Compilation of all required documents including technical, quality, and compliance files.
4. MD5 License Application (Form MD3): Submit the application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit is conducted by a CDSCO-recognized notified body to verify compliance with manufacturing and quality systems. See the Notified Bodies List.
6. Queries and Clarifications: Address any observations or queries raised by the regulatory authority or notified body.
7. License Grant: Upon satisfactory compliance, the MD5 manufacturing license is issued.

For a detailed walkthrough, consult our MD5 License Guide.

Manufacturing License Documents Required for Tachistoscope

Manufacturers must prepare and submit the following documents for the MD5 license application:

• Company Constitution: Certificate of Incorporation and related documents
• Proof of Ownership or Lease of Premises: Valid property documents
• Technical Staff Details: Qualifications and experience certificates
• Fire NOC: Fire safety clearance from local authorities
• Pollution NOC: Environmental clearance if applicable
• Device Master File (DMF): Detailed device specifications, manufacturing processes, and design controls (Device Master File Guide)
• Plant Master File (PMF): Details of manufacturing facility, equipment, and processes (Plant Master File Guide)
• Essential Principles Checklist: Compliance with safety and performance standards
• Risk Management File: Risk analysis and mitigation strategies (Risk Management)
• Test Reports: From approved testing laboratories
• Labels and Instructions for Use (IFU): Product labeling and user manual
• Quality Management System Documents: ISO 13485 compliance and SOPs

Import License Process (MD15) – Applicability for Tachistoscope

Since the Tachistoscope is a Class A device, importers require an MD15 import license granted by CDSCO’s Central Licensing Authority. The process involves:

• Document compilation including Manufacturing License, Free Sale Certificate, and ISO 13485 certification
• Application submission via the CDSCO MD Online Portal
• Evaluation by CDSCO officials
• Resolution of queries
• License grant

For detailed procedures, visit our Import License Guide.

Import License Documents Required for Tachistoscope

• Valid MD5 Manufacturing License of the manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale drug license (if applicable)
• Company constitution and ownership documents

Timeline and Processing Duration

• Test License (Form MD13): 1.5 to 2 months
• Product Testing: Concurrent with or following test license issuance, typically 1 to 2 months
• MD5 License Application and Audit: Approximately 1.5 to 2 months

Total processing time: Approximately 3 to 4 months for the entire MD5 manufacturing license process for the Tachistoscope.

For import licenses (MD15), expect 5 to 6 months, considering documentation and evaluation.

Government Fees and Costs

• MD5 License: Rs. 5,000 per application + Rs. 500 per product
• Test License: Included in MD5 procedure
• Import License (MD15):
  • Class A: $1000 per site +$50 per product

Budgeting accordingly and planning timelines realistically will help avoid delays and compliance issues.

Common Challenges and Solutions

Challenge: Delays in product testing due to limited capacity at government-approved labs.

Solution: Schedule testing early and consider multiple approved labs from the Testing Laboratories list to avoid bottlenecks.

Challenge: Documentation inconsistencies leading to audit observations.

Solution: Meticulously prepare your Device Master File, Plant Master File, and Risk Management File, leveraging expert templates and guides.

Challenge: Queries during application review causing prolonged timelines.

Solution: Engage experienced consultants to preemptively address common regulatory questions and ensure thorough submission.

Expert Consultation and Support

With decades of hands-on experience, we provide end-to-end support—from initial classification to final license issuance—for ophthalmic devices like the Tachistoscope. Our proven track record in managing CDSCO audits and regulatory compliance helps you avoid common pitfalls and accelerates your path to market.

Getting Started with Your CDSCO License Application for Tachistoscope

1. Assess your device classification: Confirm Tachistoscope as Class A using official CDSCO guidelines.
2. Prepare technical and quality documentation: Utilize our Device Master File Guide and Plant Master File Guide.
3. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
4. Arrange product testing: Coordinate with approved labs early.
5. Compile and submit MD5 License application (Form MD3): Ensure all documents meet CDSCO standards.
6. Prepare for notified body audit: Select a notified body from the official Notified Bodies List.
7. Respond promptly to queries: Keep communication clear and well-documented.

Embarking on this journey with expert guidance ensures compliance, minimizes delays, and positions your Tachistoscope successfully in the Indian ophthalmic device market.