CDSCO License for Visual projector

Introduction to Visual Projector and Its Regulatory Importance

The Visual Projector is a specialized ophthalmic device designed to project images onto a screen for testing visual acuity. Classified as a Class A medical device under the CDSCO framework, it plays a crucial role in eye care diagnostics. Given its classification and intended use, securing the correct regulatory approvals from the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturing or importing this device within India.

At our consultancy, with over 25 years of expertise and successful licensing support to 500+ companies, we understand the nuances of the CDSCO licensing process for devices like the Visual Projector. This guide offers a step-by-step, practical approach to obtaining your CDSCO license efficiently and compliantly.

CDSCO Regulatory Framework for Visual Projector (Class A Ophthalmic Device)

The Visual Projector falls under the ophthalmology category and is notified under Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021. As a Class A device, it is deemed low risk and regulated primarily by the State Licensing Authority through the MD5 license process.

The CDSCO mandates strict adherence to quality, safety, and performance standards for the Visual Projector. Compliance with the Essential Principles of Safety and Performance, accompanied by adequate documentation and testing, is required before license issuance.

Risk Classification and License Requirements for Visual Projector

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License (Application Form MD3)
• Regulatory Authority: State Licensing Authority

Class A devices such as the Visual Projector require manufacturers to obtain an MD5 license. This process incorporates a mandatory test license, product testing through CDSCO-approved labs, documentation assessment, and a notified body audit.

For a detailed understanding of medical device classification, visit our Medical Device Classification resource.

Manufacturing License Process (MD5) for Visual Projector

The MD5 license process for the Visual Projector involves several well-defined steps:

1. Test License Application (Form MD13): Obtain a test license to commence product testing. This phase takes approximately 1.5 to 2 months.

2. Product Testing: Conduct comprehensive testing at CDSCO-approved testing laboratories to verify compliance with safety and performance standards. Explore the list of approved testing labs.

3. Documentation Preparation: Compile all required documents, including Device Master File, Plant Master File, and Risk Management File.

4. MD5 License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.

5. Audit by Notified Body: Undergo an audit conducted by a notified body to verify compliance with regulatory requirements. Reference the list of notified bodies for audit scheduling.

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

7. License Grant: Upon satisfactory completion of all steps, the MD5 license is granted on Form MD5.

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

For a deeper dive into the MD5 license procedure, see our MD5 License Guide.

Manufacturing License Documents Required for Visual Projector

Accurate and complete documentation submission is critical. The following documents are mandatory:

• Company Constitution or Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing device design and specifications. Our Device Master File guide can assist you.
• Plant Master File (PMF) describing manufacturing facilities and processes. Learn more from our Plant Master File guide.
• Essential Principles Checklist
• Risk Management File demonstrating compliance with risk mitigation standards. Refer to our Risk Management resource.
• Valid Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Ensure all documents are current, accurate, and aligned with CDSCO guidelines to avoid delays.

Import License Process (MD15) for Visual Projector

While the Visual Projector is primarily a Class A device requiring an MD5 license for manufacturing, importers must secure an MD15 Import License granted by the Central Licensing Authority.

Key steps include:

• Comprehensive document preparation, including Manufacturing License, Free Sale Certificate from the country of origin, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and Wholesale License.
• Submission of Form MD14 application through the CDSCO MD Online Portal.
• Resolution of any departmental queries.
• License issuance on Form MD15.

The import license process generally takes 5 to 6 months. For detailed guidance, visit our Import License Guide.

Import License Documents Required for Visual Projector

• Valid Manufacturing License (MD5 or equivalent)
• Free Sale Certificate from the exporting country
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and Registration Documents

Completeness and authenticity of these documents are essential for smooth approval.

Timeline and Processing Duration

These timelines assume prompt response to queries and complete documentation. Delays often stem from incomplete submissions or audit scheduling.

Government Fees and Costs for Visual Projector MD5 License

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Additional costs may include testing fees charged by laboratories and audit fees by notified bodies. Budgeting for these expenses upfront can prevent surprises.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all files, especially DMF and PMF, are meticulously prepared. Utilize our guides to avoid common pitfalls.
• Delayed Testing: Coordinate closely with approved testing labs early to schedule tests.
• Audit Scheduling Delays: Engage notified bodies promptly and confirm audit dates.
• Query Response Delays: Assign dedicated personnel to address department queries swiftly.

Our practical experience shows that proactive planning and expert consultation mitigate these hurdles effectively.

Expert Consultation and Support

Navigating CDSCO licensing for the Visual Projector can be complex without experienced guidance. Our team has helped over 500 manufacturers and importers successfully obtain licenses by providing:

• Comprehensive document preparation
• Liaison with CDSCO and notified bodies
• Audit readiness training
• Post-approval compliance support

Partnering with seasoned consultants reduces approval timelines and ensures regulatory compliance.

Getting Started with Your CDSCO License Application for Visual Projector

1. Assess your device classification and licensing requirements based on the latest CDSCO notifications.
2. Prepare or update your Device Master File and Plant Master File using our detailed guides.
3. Apply for the Test License (Form MD13) via the CDSCO MD Online Portal to initiate product testing.
4. Schedule testing at CDSCO-approved laboratories. Early engagement ensures timely completion.
5. Compile all necessary documentation and QMS evidence.
6. Submit your MD5 license application (Form MD3) and coordinate audit with the notified body.
7. Respond promptly to queries and prepare for license grant.

We recommend leveraging professional support to streamline this process and avoid common delays. Reach out to our consultancy to start your Visual Projector licensing journey with confidence.