CDSCO License for Automated Radiological Image Processing Software

Understanding Automated Radiological Image Processing Software and Its Regulatory Importance

Automated Radiological Image Processing Software is a cutting-edge medical device category that leverages artificial intelligence (AI) to assist clinicians in analyzing radiological images. This software enhances diagnostic accuracy, reduces interpretation time, and supports clinical decision-making. Given its pivotal role in patient care, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures safety, efficacy, and quality before market entry in India.

This device falls under risk Class B as per the CDSCO notification 29/Misc./03/2020-DC (198) dated 13.9.2021, which recognizes software as a medical device (SaMD). Manufacturers and importers must navigate the licensing process meticulously to comply with Indian regulations and access this fast-growing market.

CDSCO Regulatory Framework for Automated Radiological Image Processing Software

The CDSCO regulates medical devices via a risk-based classification system aligned with Global Harmonization Task Force (GHTF) principles. Software devices providing diagnostic support are considered Class B, implying a moderate risk level that necessitates a state-level manufacturing license (MD5) or central-level import license (MD15).

The regulatory pathway involves:

• Obtaining a Test License (Form MD13) for product testing
• Completing product testing at CDSCO-recognized labs
• Preparing comprehensive technical documentation including Device Master File and Risk Management File
• Application submission via the CDSCO MD Online Portal
• State authority audit by a notified body
• Query resolution and license grant

Risk Classification and License Requirements for Class B Software Devices

Class B devices like Automated Radiological Image Processing Software require an MD5 manufacturing license issued by the State Licensing Authority. This license ensures that the manufacturing process and quality systems meet CDSCO standards.

For imported devices, an MD15 import license from the Central Licensing Authority is mandatory, involving more extensive documentation reflecting source country certification and compliance.

Manufacturing License Process (MD5) for Automated Radiological Image Processing Software

The MD5 license process typically spans 3 to 4 months and involves the following steps:

1. Test License Application (MD13): Apply for a test license to enable sample product testing. This phase takes approximately 1.5 to 2 months.

2. Product Testing: Conduct testing at government-approved laboratories such as those listed on the CDSCO Testing Laboratories page. Testing verifies software performance, cybersecurity, and compliance with essential principles.

3. Documentation Preparation: Compile all necessary documents including Device Master File, Plant Master File, and Risk Management File.

4. License Application Submission: Submit the Form MD3 application for the MD5 license through the CDSCO MD Online Portal.

5. Audit by Notified Body: Engage with a notified body from the official Notified Bodies List for system and process audit.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. Grant of MD5 License: Upon successful audit and documentation review, the license is issued on Form MD5.

Manufacturing License Documents Required for Automated Radiological Image Processing Software

Accurate and comprehensive documentation is critical. The following are essential:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualification and Experience Records
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed description of software design, development process, and validation. Our comprehensive Device Master File guide can assist in preparation.
• Plant Master File (PMF): Documentation of manufacturing site, facilities, equipment, and quality systems. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist demonstrating compliance with CDSCO regulations
• Risk Management File detailing hazard analysis and mitigation strategies (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation including ISO 13485 certificates

Import License Process (MD15) for Automated Radiological Image Processing Software

For importers, the MD15 license is mandatory and issued by the Central Licensing Authority. The process generally takes 5 to 6 months and includes:

1. Document Preparation: Gather manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.

2. Application Submission: Apply using Form MD14 on the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any departmental queries.

4. License Grant: License issued on Form MD15.

Note that a test license is not required for import applications.

Import License Documents Required

• Manufacturing License of the product from the country of origin
• Free Sale Certificate issued by the competent authority
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for distribution within India
• Company Constitution and Incorporation documents

Timeline and Processing Duration

Timely document submission and quick resolution of queries can significantly reduce processing delays.

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Fees vary; consult CDSCO portal
• MD15 Import License:
  • Class B devices: Rs 2000 per site + Rs 1000 per product

Additional costs include testing fees at approved laboratories and audit fees charged by notified bodies.

Common Challenges and Solutions

• Incomplete Documentation: Missing or inadequate Device Master Files often cause delays. Engage experienced consultants to ensure completeness.

• Test Lab Delays: Scheduling tests at government labs can be time-consuming. Plan early and provide accurate samples.

• Audit Non-Conformities: Prepare your quality management system thoroughly to avoid observations during audits.

• Query Management: Maintain prompt and accurate communication with CDSCO authorities to expedite resolutions.

Expert Consultation and Support

With over 25 years of regulatory consulting experience and having assisted 500+ companies, we offer tailored support for Automated Radiological Image Processing Software licensing. Our services include:

• Comprehensive gap analysis and documentation preparation
• Coordination with notified bodies and testing laboratories
• Application filing and query handling
• Training on CDSCO compliance and audit readiness

Our goal is to streamline your journey to market entry while ensuring full regulatory compliance.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm Class B status and applicable notifications.

2. Initiate Test License Application: Submit Form MD13 on the CDSCO MD Online Portal to commence testing.

3. Engage Accredited Testing Labs: Schedule product testing early to avoid bottlenecks.

4. Prepare Technical Documentation: Use our master file guides to develop robust Device and Plant Master Files.

5. Select a Notified Body: Choose one from the official list for audits.

6. Submit MD5 Application: After successful testing, apply for the manufacturing license with all supporting documents.

7. Plan for Audit and Query Resolution: Be responsive and well-prepared to expedite license grant.

Partnering with experienced regulatory consultants can transform this complex process into a structured, manageable journey. Contact us today to leverage our expertise and achieve your CDSCO licensing goals efficiently.