CDSCO License for Diagnostic x-ray tube mount

Comprehensive Guide to CDSCO Licensing for Diagnostic X-ray Tube Mount (Class A Medical Device)

Introduction: Understanding the Diagnostic X-ray Tube Mount and Its Regulatory Importance

A Diagnostic X-ray Tube Mount is a crucial component in interventional radiology, designed to securely support and position the diagnostic x-ray tube housing assembly during radiographic procedures. Given its vital role in medical imaging, ensuring compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations is paramount for manufacturers and importers aiming to market this device in India.

With over 25 years of experience assisting 500+ companies in successfully navigating the CDSCO licensing landscape, we provide you with specialized, step-by-step guidance tailored specifically for Class A medical devices like the Diagnostic X-ray Tube Mount.

CDSCO Regulatory Framework for Diagnostic X-ray Tube Mount

The CDSCO governs the import, manufacture, and sale of medical devices in India under the Medical Device Rules (MDR) 2017, notified on January 31, 2017. Your device falls under the interventional radiology category with Notification No. 29/Misc./03/2020-DC (146), dated 26.07.2021.

As a Class A device (low risk), the regulatory pathway is comparatively streamlined but still requires adherence to key quality, safety, and performance standards. Compliance ensures patient safety and facilitates smooth market entry.

Risk Classification and License Requirements for Diagnostic X-ray Tube Mount

Medical devices in India are classified into four risk classes: A, B, C, and D. The Diagnostic X-ray Tube Mount is classified as Class A, indicating a low-risk device. Consequently, the manufacturing license required is the MD5 License, issued by the State Licensing Authority.

For Class A devices, the licensing process involves:

Obtaining a Test License (Form MD13) to initiate sample testing
Product testing at CDSCO-approved laboratories
Submission of the manufacturing license application (Form MD3) for MD5
Audit by a notified body
Resolution of any queries raised by the regulatory authorities

Manufacturing License Process (MD5) for Diagnostic X-ray Tube Mount

The MD5 license process typically spans 3 to 4 months, encompassing the following stages:

Test License Application (Form MD13): Apply for a test license to conduct mandatory product testing. This stage takes approximately 1.5 to 2 months.
Product Testing: Submit samples to a CDSCO-approved testing laboratory. You can find the list of testing laboratories here.
Document Preparation: Compile comprehensive documents including Device Master File, Plant Master File, and Quality Management System (QMS) documents.
Filing MD5 Manufacturing License Application (Form MD3): Submit your application via the CDSCO MD Online Portal.
Audit by Notified Body: Coordinate with a notified body from the official notified bodies list for facility and quality audits.
Query Resolution: Address any observations or queries from both the notified body and CDSCO.
License Grant: Upon satisfactory compliance, the MD5 license will be granted.

Manufacturing License Documents Required for Diagnostic X-ray Tube Mount

For a Class A device such as the Diagnostic X-ray Tube Mount, the following documents are essential:

Company Constitution (e.g., Memorandum of Association, Partnership Deed)
Proof of Ownership or Lease Agreement of the manufacturing premises
Technical Staff Qualifications and Experience
Fire Safety NOC and Pollution Control NOC
Device Master File (DMF): Detailed device specifications and design controls. Our Device Master File guide can assist you in preparation.
Plant Master File (PMF): Details of manufacturing processes and facilities. Refer to our Plant Master File guide for best practices.
Essential Principles Checklist: Compliance with notified essential principles
Risk Management File: Documentation of risk analysis and mitigation as per ISO 14971 standards. Visit our Risk Management resource for insights.
Test Reports from CDSCO-approved Labs
Product Labels and Instructions for Use (IFU)
Quality Management System Documentation: Typically ISO 13485:2016 certification

Import License Process (MD15) for Diagnostic X-ray Tube Mount

Since your device is a Class A device, importers will require an MD15 import license issued by the Central Licensing Authority. The MD15 application process usually takes 5 to 6 months and involves:

Preparation of required documents (including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate)
Submission of application on the CDSCO MD Online Portal
Query resolution
License issuance

While the import license process is slightly longer, it ensures adherence to both Indian and international standards, facilitating seamless importation.

Import License Documents Required for Diagnostic X-ray Tube Mount

Importers must submit the following:

Valid Manufacturing License from the 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 Documents

Timeline and Processing Duration

Process Stage	Duration
Test License (MD13)	1.5 to 2 months
Product Testing	1 to 1.5 months
Document Preparation & Submission	2 to 3 weeks
Audit & Query Resolution	1 to 1.5 months
Total MD5 License Timeframe	3 to 4 months

Government Fees and Costs

For Class A devices like the Diagnostic X-ray Tube Mount, the fees are as follows:

Application Fee: INR 5,000 per application
Product Fee: INR 500 per product

These fees are payable online through the CDSCO portal during the application process.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Engage early with CDSCO-approved testing laboratories and ensure samples meet submission criteria. Regular follow-ups can expedite testing.

Challenge 2: Incomplete Document Submission

Solution: Use detailed checklists and consult our MD5 License Guide to prepare error-free applications.

Challenge 3: Audit Non-compliance

Solution: Conduct internal audits and gap assessments before the notified body audit. Maintain updated QMS documentation.

Challenge 4: Query Resolution Delays

Solution: Respond promptly and comprehensively to queries with supporting evidence.

Expert Consultation and Support

Navigating CDSCO regulations can be complex, especially for first-time applicants. With our extensive experience assisting over 500 companies, we offer tailored consultancy services including:

End-to-end license application management
Documentation preparation and review
Pre-audit readiness assessments
Liaison with CDSCO and notified bodies

Our expertise ensures faster approvals and regulatory compliance, minimizing your time-to-market.

Getting Started with Your CDSCO License Application

Initiate Device Classification Confirmation: Verify your device classification using Medical Device Classification resources.
Register on the CDSCO MD Online Portal: Begin your license application process by creating an account on the official portal.
Prepare Key Documents: Start compiling your Device Master File, Plant Master File, and QMS documentation.
Apply for Test License (Form MD13): Submit your test license application and plan sample testing.
Engage with Notified Bodies and Testing Labs: Schedule audits and testing early to avoid bottlenecks.
Leverage Professional Support: Consider partnering with experienced consultants to streamline your licensing journey.

By following these actionable steps and leveraging our expert insights, manufacturers and importers of the Diagnostic X-ray Tube Mount can confidently navigate CDSCO licensing requirements, ensuring compliance and successful market access in India.

CDSCO License for Diagnostic x-ray tube mount

Medical Device Information

Important Notice for Class A Devices

Intended Use