CDSCO License for Diagnostic x-ray beam-limiting device

Comprehensive Guide to CDSCO Licensing for Diagnostic X-ray Beam-Limiting Devices (Class C)

Navigating the regulatory landscape in India for medical devices can be complex, especially for manufacturers and importers of specialized equipment like the Diagnostic X-ray Beam-Limiting Device. As a critical component in interventional radiology, this device—such as collimators, cones, or apertures designed to restrict the size of the primary diagnostic x-ray beam—is classified under Class C by CDSCO as per Notification 29/Misc./03/2020-DC (146) dated 26.07.2021.

With over 25 years of experience and support to more than 500 companies, we bring you detailed insights and practical guidance tailored specifically for this device category to ensure a smooth CDSCO licensing process.

CDSCO Regulatory Framework for Diagnostic X-ray Beam-Limiting Devices

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR), 2017, which came into full effect on January 1, 2018. As per these rules, the Diagnostic X-ray Beam-Limiting Device falls under the interventional radiology category and is classified as a Class C device due to its moderate to high risk profile.

Manufacturers and importers of Class C devices must apply for the MD9 manufacturing or import license, which is granted by the Central Licensing Authority. This ensures that the device complies with Indian safety, quality, and performance standards before entering the market.

Risk Classification and License Requirements for Class C Diagnostic X-ray Beam-Limiting Devices

Risk Class: C (Moderate to High Risk)
Applicable License: MD9 Manufacturing License for domestic manufacturers; MD15 Import License for importers
Regulatory Authority: Central Licensing Authority, CDSCO
Relevant Notification: 29/Misc./03/2020-DC (146), dated 26.07.2021

Manufacturing License Process (MD9) for Diagnostic X-ray Beam-Limiting Devices

Manufacturers intending to produce this device in India must secure the MD9 license. The process typically spans 4 to 5 months, involving several critical steps:

Test License Application (Form MD13): Obtain a test license to manufacture the device in limited quantity for testing and validation. This phase takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory testing at government-approved laboratories to validate device safety and performance. Refer to the list of CDSCO-approved testing laboratories for accredited facilities.
Documentation Preparation: Prepare comprehensive technical documentation, including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
License Application Submission (Form MD7): Submit the complete application for the MD9 license through the CDSCO MD Online Portal.
Audit and Inspection: CDSCO officials conduct an on-site audit of manufacturing facilities and review documentation.
Query Resolution: Address any observations or queries raised by CDSCO during the audit.
License Grant: Upon satisfactory compliance, CDSCO issues the MD9 license (Form MD9), enabling commercial manufacturing.

Manufacturing License Documents Required for MD9 Application

To ensure a smooth application process, prepare the following essential documents:

Company Constitution and Incorporation Certificates
Proof of Ownership or Lease Agreement of Manufacturing Premises
Details and Qualifications of Technical Staff
Fire Safety NOC and Pollution Control Board NOC
Device Master File (DMF) detailing device design, specifications, and manufacturing process (Learn more about DMFs here)
Plant Master File (PMF) outlining facility layout, equipment, and processes (Guide to PMF preparation)
Essential Principles Checklist demonstrating compliance with Indian regulatory requirements
Risk Management File following ISO 14971 standards (Risk management insights)
Test Reports from CDSCO-approved laboratories
Product Labels and Instructions for Use (IFU)
Quality Management System Documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Diagnostic X-ray Beam-Limiting Devices

Importers must apply for an MD15 license, which is granted by the Central Licensing Authority. The process usually takes around 5 to 6 months and involves:

Document Preparation: Assemble all required documentation, including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
License Application (Form MD14): Submit the application on the CDSCO MD Online Portal.
Query Resolution: Respond promptly to any departmental queries.
License Issuance: After satisfactory review, CDSCO issues the MD15 import license.

Import License Documents Required for MD15 Application

Manufacturing License of the foreign manufacturer
Free Sale Certificate from the country of origin
ISO 13485:2016 certification
CE Certificate or equivalent
Device Master File (DMF)
Plant Master File (PMF)
Wholesale Drug License
Company Constitution and Incorporation Documents

Timeline and Processing Duration

Process Stage	Duration
Test License (MD13)	1.5 to 2 months
Product Testing	1 to 1.5 months
Documentation Preparation	1 to 1.5 months
License Application Review	1 month
Audit and Inspection	2 to 3 weeks
Query Resolution and Final Approval	2 to 4 weeks

Total Estimated Time for MD9 License: Approximately 4 to 5 months

Total Estimated Time for MD15 Import License: Approximately 5 to 6 months

Government Fees and Costs

MD9 Manufacturing License Fees:

Application Fee: Rs. 50,000 per application
Product-wise Fee: Rs. 1,000 per product

MD15 Import License Fees (Class C Devices):

Site Fee: $3,000 per site
Product Fee: $1,500 per product

Note: Fees are subject to change; always verify current rates on the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Engage early with CDSCO-approved testing laboratories and pre-book testing slots. Maintain clear communication and provide complete samples to avoid retesting.

Challenge 2: Incomplete or Poor Documentation

Solution: Utilize templates for Device Master File and Plant Master File, and ensure alignment with ISO 13485 requirements. Our Device Master File guide offers detailed instructions.

Challenge 3: Audit Non-Compliance

Solution: Conduct internal audits prior to CDSCO inspection. Ensure facility readiness, personnel training, and document availability.

Challenge 4: Query Resolution Delays

Solution: Assign dedicated regulatory personnel to respond quickly and accurately to CDSCO queries.

Expert Consultation and Support

With our extensive experience supporting over 500 companies in obtaining CDSCO licenses, we provide end-to-end regulatory consultancy:

Gap analysis and readiness assessment
Documentation drafting and review
Liaison with CDSCO and notified bodies
Training for internal audits and compliance
Assistance through every stage of licensing

Our practical insights help manufacturers and importers avoid common pitfalls and accelerate time-to-market.

Getting Started with Your CDSCO License Application

Identify Device Classification: Confirm the classification of your Diagnostic X-ray Beam-Limiting Device as Class C using the Medical Device Classification resource.
Prepare Test License Application: If manufacturing, apply for the MD13 test license via the CDSCO MD Online Portal.
Engage Approved Testing Laboratories: Schedule testing with CDSCO-recognized labs.
Compile Comprehensive Documentation: Use our guides for Device Master File and Plant Master File preparation.
Submit MD9 or MD15 Application: Complete and submit your application on the CDSCO portal.
Plan for Audit and Inspection: Ensure your facility and team are audit-ready.
Respond to CDSCO Queries Promptly: Assign skilled personnel for swift communication.

Starting early and following a structured approach can significantly reduce licensing timelines and enhance your chances of approval. Connect with us for personalized support tailored to your device and business needs.

For more detailed insights on MD9 licensing, visit our MD9 License Guide.

We are committed to helping you bring your Diagnostic X-ray Beam-Limiting Device to the Indian market efficiently and compliantly.

CDSCO License for Diagnostic x-ray beam-limiting device

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