CDSCO License for Motorized diagnostic imaging view box

Comprehensive Guide to CDSCO License for Motorized Diagnostic Imaging View Box (Class A Device)

Navigating the regulatory landscape for medical devices in India can seem daunting, especially for specialized equipment like the Motorized Diagnostic Imaging View Box. As a device classified under Class A, it falls under low-risk category but still demands strict compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations. With over 25 years of experience supporting 500+ companies in obtaining CDSCO licenses, we bring you an authoritative and practical guide tailored specifically for your Motorized Diagnostic Imaging View Box.

Understanding the Motorized Diagnostic Imaging View Box and Its Regulatory Importance

The Motorized Diagnostic Imaging View Box is a crucial operation theatre device designed to project and retrieve medical images such as X-ray, MRI, CT, and ultrasound films for direct observation. Motorized control through electric, mechanical, or software means enhances precision and ease of use. Given its specialized application, ensuring regulatory compliance is essential not only for legal marketing in India but also for safeguarding patient safety and institutional reliability.

CDSCO Regulatory Framework for Motorized Diagnostic Imaging View Box

Since this device is categorized under Class A (low risk) by CDSCO, it falls under the ambit of the State Licensing Authority for manufacturing licenses. The regulatory framework mandates adherence to the Medical Device Rules (MDR), 2017, and subsequent notifications, including the specific Notification File No. 29/Misc/03/2020-DC (199) dated 13.9.2021.

The licensing process involves multiple stages: obtaining a test license, product testing by government-approved labs, documentation preparation, application filing on the CDSCO MD Online Portal, audit by notified bodies, and final license grant.

Risk Classification and License Requirements for Class A Devices

Class A devices like the Motorized Diagnostic Imaging View Box require an MD5 Manufacturing License, which is granted by the State Licensing Authority. The MD5 license process is relatively streamlined compared to higher-risk classes but still necessitates comprehensive documentation and compliance.

You can learn more about the classification and confirm your device’s risk class on the Medical Device Classification guide.

Manufacturing License Process (MD5) for Motorized Diagnostic Imaging View Box

1. Test License (Form MD13): Before applying for the manufacturing license, a test license must be obtained. This step allows you to manufacture the device in limited quantities for testing purposes.

2. Product Testing: The device must be tested at government-approved laboratories to validate safety and performance. Refer to the list of Testing Laboratories for accredited facilities.

3. Documentation Preparation: Prepare all required documents including Device Master File, Plant Master File, Quality Management System (QMS) documents, and risk management files.

4. Application Submission (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body will conduct an audit of your manufacturing premises and quality systems. Check the list of notified bodies for authorized auditors.

6. Query Resolution: Respond promptly to any queries raised by the department or notified body.

7. License Grant: On successful review and audit, the MD5 license will be granted.

For an in-depth walkthrough, see our MD5 License Guide.

Manufacturing License Documents Required for Class A Device

To ensure a smooth application process, assemble the following documents meticulously:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) outlining device specifications, design, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) detailing manufacturing facility and quality systems (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with Indian MDR
• Risk Management File evidencing hazard identification and mitigation (Risk Management)
• Test Reports from government-approved laboratories
• Sample Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, typically ISO 13485:2016 certificate

Import License Process (MD15) – Applicable for Importers

If you intend to import the Motorized Diagnostic Imaging View Box, the import license is issued under Form MD15 by the Central Licensing Authority. The process includes:

• Document preparation including Importer’s Manufacturing License, Free Sale Certificate, ISO 13485 certification, CE Certificate, Device and Plant Master Files, and Wholesale License.
• Application submission on the CDSCO MD Online Portal.
• Resolution of any queries raised during review.
• Grant of Import License.

The entire import license process takes approximately 5-6 months.

For detailed guidance, refer to our Import License Guide.

Import License Documents Required for Motorized Diagnostic Imaging View Box

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

Timeline and Processing Duration

For a Class A device like the Motorized Diagnostic Imaging View Box, expect the following timelines:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months (depending on lab capacity and device complexity)
• Document Preparation: Parallel with testing, approximately 1 month
• Application Processing & Audit: 1 to 1.5 months
• Query Resolution and License Grant: 2 to 3 weeks

Total Estimated Time: Approximately 3 to 4 months from start to finish.

Government Fees and Costs Breakdown

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product
• Testing and Audit Costs: Variable, depending on notified body and testing laboratory charges

Budgeting realistically for additional consultancy or documentation assistance is advisable to avoid delays.

Common Challenges and Solutions

• Delayed Testing Reports: Engage early with notified testing laboratories to schedule tests and clarify protocols.
• Incomplete Documentation: Use comprehensive checklists and consult experts to ensure all technical and regulatory documents meet CDSCO standards.
• Audit Non-Compliance: Conduct internal audits and pre-audit assessments to prepare your facility and QMS.
• Query Resolution Delays: Assign dedicated personnel to monitor and respond to CDSCO queries promptly.

Expert Consultation and Support

Our extensive experience has shown that early regulatory consultation dramatically shortens approval timelines and reduces rejections. We assist with:

• Device classification confirmation
• Drafting and reviewing Device and Plant Master Files
• Preparation of risk management and essential principles checklists
• Coordinating with notified bodies and testing labs
• End-to-end application submission and follow-up

Getting Started with Your CDSCO License Application

1. Confirm Device Classification: Verify the Motorized Diagnostic Imaging View Box is Class A on the CDSCO classification portal.

2. Register on CDSCO MD Online Portal: Create your account at the CDSCO MD Online Portal.

3. Prepare Test License Application: Start with Form MD13 to obtain the test license.

4. Plan Product Testing: Contact government-approved labs early to schedule testing.

5. Gather Required Documents: Use our detailed documentation checklist for Class A devices.

6. Engage a Notified Body: Arrange for audit early to avoid bottlenecks.

7. Submit Manufacturing License Application: Once testing and documents are ready, apply via Form MD3.

8. Track Application and Respond: Monitor application status and promptly address queries.

By following these steps with expert guidance, your Motorized Diagnostic Imaging View Box can enter the Indian market with full regulatory compliance, ensuring patient safety and business success.

For tailored support and to expedite your CDSCO licensing process, connect with our seasoned regulatory consultants today.