CDSCO License for Angiographic x- ray system

Comprehensive Guide to CDSCO Licensing for Angiographic X-Ray Systems (Class C Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 companies, we understand the complexities manufacturers and importers face when entering the Indian market. The angiographic X-ray system, classified as a Class C medical device under the CDSCO framework, requires navigating a stringent licensing process to ensure compliance and patient safety.

Introduction: Angiographic X-Ray System and Its Regulatory Importance

An angiographic X-ray system is a sophisticated interventional radiology device designed for radiologic visualization of the heart, blood vessels, or lymphatic system during or after the injection of contrast medium. Given its critical role in diagnostic and therapeutic procedures, the device falls under Class C risk classification as per CDSCO Notification 29/Misc./03/2020-DC (146), dated 26.07.2021.

This classification mandates a rigorous review to ensure the device meets safety, efficacy, and quality standards before market authorization. Understanding these regulatory requirements is essential for successful market entry.

CDSCO Regulatory Framework for Angiographic X-Ray Systems

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India, with the Ministry of Health as the licensing authority. For Class C devices like angiographic X-ray systems, the licensing authority is the Central Licensing Authority (CLA). License applications are processed through the CDSCO MD Online Portal, ensuring a streamlined and transparent submission process.

Risk Classification and License Requirements

Angiographic X-ray systems fall under Class C due to their invasive nature and potential impact on critical bodily functions. This risk class demands an MD9 manufacturing license for locally manufactured devices or an MD15 import license for imported devices.

• MD9 License (Manufacturing of Class C Devices): Issued by the Central Licensing Authority.
• MD15 License (Import of Class C Devices): Also issued by the Central Licensing Authority.

For this guide, we will focus on the manufacturing license process (MD9), as it provides comprehensive insights applicable to importers as well.

Manufacturing License Process (MD9) for Class C Devices

The MD9 license process is a multi-step procedure typically spanning 4-5 months. It encompasses test licensing, product testing, documentation, application submission, audit, and licensing.

Step 1: Obtain Test License (Form MD13) Manufacturers must first apply for a test license to legally produce the device samples required for testing. This process takes approximately 1.5-2 months.

Step 2: Product Testing Device samples are tested in government-approved laboratories to verify compliance with relevant standards. You can refer to the list of CDSCO-approved testing laboratories for selection.

Step 3: Document Preparation Prepare comprehensive documentation, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.

Step 4: Application Submission (Form MD7) Submit the MD9 application on the CDSCO MD Online Portal along with the required documents and government fees.

Step 5: Audit by CDSCO Inspectors CDSCO conducts a detailed audit of manufacturing facilities, quality systems, and documentation.

Step 6: Resolution of Queries Address any queries raised by CDSCO or during the audit promptly.

Step 7: Grant of MD9 License Upon satisfactory compliance, CDSCO issues the MD9 manufacturing license.

For deeper insights, our MD9 License Guide provides a step-by-step roadmap.

Manufacturing License Documents Required for Angiographic X-Ray Systems

Successful MD9 license applications require meticulous preparation of the following documents:

• Company Constitution (Incorporation Certificate, MOA, AOA)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Credentials of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing device specifications, design, and manufacturing processes. Refer to our Device Master File guide for detailed requirements.
• Plant Master File (PMF) describing manufacturing facilities and processes. See our Plant Master File guide for assistance.
• Essential Principles Checklist ensuring compliance with Indian Medical Device Rules
• Risk Management File demonstrating identification, evaluation, and mitigation of risks, aligned with ISO 14971. Learn more about risk management here.
• Test Reports from CDSCO-approved laboratories
• Device Labels and Instructions for Use (IFU) compliant with regulatory standards
• Quality Management System (QMS) documentation, typically ISO 13485:2016 certification

Import License Process (MD15) for Class C Devices

For importers of angiographic X-ray systems, the MD15 import license process involves:

• Preparing necessary documentation including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Submitting application on Form MD14 via the CDSCO MD Online Portal.
• Responding to departmental queries.
• Awaiting grant of MD15 license, generally within 5-6 months.

Our Import License Guide offers a comprehensive overview.

Timeline and Processing Duration

Government Fees and Costs

Additional costs include testing fees at government-approved labs (varies depending on device complexity and number of tests required) and audit costs.

Common Challenges and Solutions

Challenge 1: Delays in Document Preparation Solution: Start early with documentation, use checklists, and consult experienced regulatory experts to ensure completeness.

Challenge 2: Product Testing Failures Solution: Conduct pre-testing audits and quality checks in-house and select accredited labs from the CDSCO Testing Laboratories list.

Challenge 3: Audit Non-Compliance Findings Solution: Align manufacturing practices with ISO 13485 and Indian Medical Device Rules; conduct internal audits to identify gaps.

Challenge 4: Delays in Query Resolution Solution: Assign dedicated regulatory personnel for timely and accurate responses.

Expert Consultation and Support

Navigating the CDSCO licensing process for Class C devices like angiographic X-ray systems demands expert knowledge and experience. Our regulatory consulting services provide:

• Tailored guidance through each licensing step
• Assistance in preparing and reviewing Device and Plant Master Files
• Liaison with CDSCO officials and notified bodies
• Training for internal teams on compliance and audit readiness

Getting Started with Your CDSCO License Application

Embarking on your CDSCO license journey for your angiographic X-ray system? Here’s a practical roadmap:

1. Assess Device Classification: Confirm your device’s Class C status and regulatory requirements.
2. Establish QMS: Implement ISO 13485:2016 compliant quality management systems.
3. Prepare Test Samples: Initiate the test license (Form MD13) application on the CDSCO MD Online Portal.
4. Identify Testing Laboratory: Choose an accredited lab from the CDSCO-approved list.
5. Compile Documentation: Use our guides for Device Master File and Plant Master File preparation.
6. Submit MD9 Application: Once testing is complete, apply using Form MD7.
7. Prepare for Audit: Conduct internal audits and training.
8. Respond Promptly: Address any CDSCO queries swiftly to avoid delays.

Partnering with experienced regulatory consultants can turn this complex process into a structured and efficient pathway to market. Reach out to us to leverage our expertise and ensure your angiographic X-ray system meets all regulatory benchmarks for successful commercialization in India.