CDSCO License for Wall-mounted radiographic cassette holder

Comprehensive Guide to CDSCO Licensing for Wall-Mounted Radiographic Cassette Holders (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and more than 500 successful CDSCO licensing projects, we understand the nuances of medical device approvals in India. If you are manufacturing or importing a Wall-mounted radiographic cassette holder, a Class A medical device under the Interventional Radiology category, this guide covers everything you need to know – from regulatory frameworks to detailed timelines, costs, and documentation.

Understanding the Device and Regulatory Importance

A Wall-mounted radiographic cassette holder is a critical support device designed to hold and position radiographic cassettes during medical imaging procedures. Proper positioning ensures accurate radiographic exposure, patient safety, and diagnostic quality. Although it is classified as a low-risk (Class A) device by CDSCO, regulatory compliance is mandatory to legally manufacture or import this device in India.

The device was notified under the CDSCO Medical Device Rules 2017 notification number 29/Misc./03/2020-DC (146) dated 26.07.2021. This formal inclusion means manufacturers must obtain a valid MD5 manufacturing license from the State Licensing Authority before commercialization.

CDSCO Regulatory Framework for Wall-Mounted Radiographic Cassette Holders

The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India through a tiered risk-based approach:

Class A & B devices (low risk) are licensed by the State Licensing Authority.
Class C & D devices (medium to high risk) require Central Licensing Authority approval.

Since the Wall-mounted radiographic cassette holder is Class A, the application for license is made on Form MD3 for an MD5 license via the State Licensing Authority.

All applications must be submitted online through the CDSCO MD Online Portal to ensure traceability and transparency.

Risk Classification and License Requirements

Medical devices are classified based on their intended use and risk to patients/users. This device is Class A, indicating the lowest risk category. However, compliance requirements include:

Obtaining a Test License (Form MD13) initially for product testing.
Product testing from CDSCO-approved labs.
Preparation and submission of technical documentation.
Audit by a notified body.
Applying for and obtaining the MD5 license (Form MD3).

Refer to the detailed Medical Device Classification guide to better understand where your device fits.

Manufacturing License Process (MD5 License for Class A Devices)

Step 1: Apply for Test License (Form MD13)

Begin by submitting an application for the Test License, which permits you to conduct product testing. This process typically takes 1.5 to 2 months.

Step 2: Product Testing

You must get your device tested at one of the CDSCO-approved testing laboratories. Ensure that tests comply with applicable Indian or international standards.

Step 3: Documentation Preparation

After successful testing, prepare your license application documents, including the Device Master File and Plant Master File. We recommend consulting our Device Master File guide and Plant Master File guide for comprehensive documentation standards.

Step 4: Submit MD5 License Application (Form MD3)

Apply online through the CDSCO MD Online Portal with all required documents.

Step 5: Audit by Notified Body

A notified body listed on the CDSCO Notified Bodies List will conduct an on-site audit of your manufacturing facility and quality management system.

Step 6: Query Resolution

Address any observations or queries raised by the licensing authority or notified body promptly to avoid delays.

Step 7: Grant of MD5 License

Upon successful audit and document approval, the State Licensing Authority will issue the manufacturing license on Form MD5.

Manufacturing License Documents Required

To streamline your application, ensure you have the following ready:

Company Constitution Documents (Incorporation Certificate, partnership deed, etc.)
Proof of Premises Ownership or Lease Agreement
Technical Staff Qualification Proofs
Fire and Pollution NOCs
Device Master File (DMF) detailing design, specifications, materials, and manufacturing processes
Plant Master File (PMF) describing facility layout, equipment, and quality systems
Essential Principles Checklist confirming compliance with safety and performance standards
Risk Management File demonstrating hazard analysis and mitigation steps
Product Test Reports from CDSCO-approved labs
Labels and Instructions for Use (IFU)
Quality Management System (QMS) Documents (e.g., ISO 13485 certification)

Having all these documents meticulously prepared reduces back-and-forth with regulators and expedites approval.

Import License Process (MD15 License) for Wall-Mounted Radiographic Cassette Holders

If you plan to import this device into India, you must obtain an MD15 Import License issued by the Central Licensing Authority. The process generally:

Does not require a test license.
Requires comprehensive documentation including your manufacturing license, Free Sale Certificate, ISO 13485 certificate, CE certification (if applicable), Device and Plant Master Files.
Involves a detailed review and clearance process that takes approximately 5 to 6 months.

For a detailed walkthrough, check our Import License Guide.

Timeline and Processing Duration

Process Step	Approximate Duration
Test License Application	1.5 to 2 months
Product Testing	3 to 4 weeks (depends on lab)
Documentation Preparation	2 to 4 weeks
MD5 License Application & Audit	1 to 1.5 months
Query Resolution	2 to 4 weeks
Total	3 to 4 months

Adhering to timelines and promptly responding to queries can help avoid unnecessary delays.

Government Fees and Costs

The fee structure for MD5 licenses (Class A devices) is as follows:

Application fee: Rs. 5,000 per application
Product fee: Rs. 500 per product

Additional costs include:

Fees charged by notified bodies for audits (varies by body)
Testing lab fees (varies based on tests required)
Documentation preparation and consultancy fees (if outsourced)

Budgeting for these expenses upfront is essential for smooth project management.

Common Challenges and Solutions

Incomplete Documentation: Many manufacturers delay licensing due to missing or improper documents. Use checklists and expert guidance to ensure full compliance.
Delays in Testing: Testing labs often have backlogs. Schedule tests well in advance and select labs with shorter turnaround times.
Audit Non-Compliance: Ensure your QMS and manufacturing facilities are fully audit-ready before the notified body visit.
Query Resolution Delays: Respond to regulator queries promptly with clear evidence and documentation.

Our consultancy has helped clients overcome these hurdles by proactive planning and expert advice.

Expert Consultation and Support

Navigating CDSCO licensing can be complex for first-timers. We provide end-to-end support, including:

Gap analysis of your current compliance status
Preparation of Device and Plant Master Files
Coordination with testing laboratories and notified bodies
Application drafting and submission through the CDSCO MD Online Portal
Audit readiness and mock inspections
Prompt query resolution support

Our proven track record of 500+ successful licenses speaks to our commitment to client success.

Getting Started with Your CDSCO License Application

Assess Your Device Classification: Confirm your device as Class A under the current CDSCO notifications.
Prepare Documentation: Begin assembling your Device Master File, Plant Master File, risk management, and QMS documents.
Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
Arrange Product Testing: Coordinate with CDSCO-approved labs early to avoid bottlenecks.
Plan for Notified Body Audit: Choose a notified body from the official list and prepare your facility accordingly.
Submit MD5 License Application: Once testing and documentation are complete, apply with Form MD3.
Maintain Clear Communication: Stay responsive to queries and audit recommendations.

Embarking on your CDSCO licensing journey with a clear roadmap and expert support can save months and avoid costly pitfalls. Contact us today to leverage our expertise and get your Wall-mounted radiographic cassette holder licensed efficiently and compliantly for the Indian market.