CDSCO License for Software for film-recorded digital radiography

Comprehensive CDSCO Licensing Guide for Software for Film-Recorded Digital Radiography (Class B)

Navigating the regulatory landscape for medical device software in India can be complex. As experts with over 25 years of experience and having successfully guided 500+ companies, we provide you with a detailed roadmap to secure your CDSCO license for Software for Film-Recorded Digital Radiography, classified as a Class B medical device.

Introduction to Software for Film-Recorded Digital Radiography and Regulatory Importance

This software is designed to process data obtained from film-recorded digital radiography systems, enabling clinicians to analyze and diagnose medical conditions accurately. Given its critical role in healthcare diagnostics, regulatory compliance ensures safety, efficacy, and market access in India.

The device falls under the Class B risk category, indicating a low to moderate risk level, and is regulated by the Central Drugs Standard Control Organization (CDSCO) under notification number 29/Misc./03/2020-DC (198) dated 13.9.2021.

CDSCO Regulatory Framework for Software-Based Medical Devices

India’s regulatory framework for medical devices, including software, is governed by the Medical Device Rules (MDR) 2017, enforced by CDSCO. Software as a Medical Device (SaMD) is subject to the same rigorous compliance as physical devices, ensuring adherence to quality and safety standards.

Manufacturers of Class B devices like this software must apply for a Manufacturing License (MD5) from the State Licensing Authority. This license permits manufacturing and marketing within India.

Risk Classification and License Requirements for Class B Software

Class B devices pose low to moderate risk and require:

• MD5 Manufacturing License (Form MD3)
• Initial Test License (Form MD13) to conduct product testing
• Product testing in CDSCO-approved laboratories
• Audit by a notified body

This structured process ensures that the software meets Indian regulatory expectations before commercial distribution.

Manufacturing License Process for Software (MD5 License)

The journey to obtaining the MD5 license involves several critical steps:

1. Apply for Test License (Form MD13): This initial license allows you to test your software in an approved laboratory.
2. Product Testing: Submit your software for technical and safety evaluation to a CDSCO-recognized testing laboratory.
3. Document Preparation: Compile required documentation, including Device Master File, Plant Master File, risk management reports, and quality management system documents.
4. Application for MD5 License (Form MD3): Submit your application via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body will conduct a facility audit and review documentation. Find the list of notified bodies here.
6. Resolution of Queries: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of License: Upon satisfactory compliance, the MD5 license is granted, allowing manufacturing and sale.

Manufacturing License Documents Required for Software Devices

For a Class B software device, prepare the following documents meticulously:

• Company Constitution Documents: Incorporation certificate, PAN, GST details
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Certificates
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailing software design, development, validation, and maintenance. Our detailed Device Master File guide can assist in preparation.
• Plant Master File (PMF): Covering manufacturing processes and quality systems. Learn how to create it effectively in our Plant Master File guide.
• Essential Principles Checklist: Compliance with MDR 2017 requirements
• Risk Management File: Following ISO 14971 principles. Refer to our risk management guide.
• Test Reports: From government-approved testing laboratories. Check the list of testing laboratories.
• Labels and Instructions for Use (IFU): Compliant with Indian regulations
• Quality Management System (QMS) Documents: ISO 13485 certification or equivalent documentation

Import License Process (MD15) for Software Devices

If your software product is manufactured outside India and you intend to import it, you must secure an MD15 Import License from the CDSCO Central Licensing Authority.

Key steps include:

• Document preparation (including Manufacturing License, Free Sale Certificate, CE Certificate, ISO 13485:2016, Device and Plant Master Files)
• Application submission on the CDSCO MD Online Portal
• Resolution of departmental queries
• Grant of Import License on Form MD15

Refer to our comprehensive Import License guide for detailed assistance.

Timeline and Processing Duration for MD5 License (Class B Software)

• Test License (Form MD13): Approximately 1.5 to 2 months
• Product Testing: 3 to 4 weeks, depending on lab workload
• Document Preparation: Varies, typically 4 to 6 weeks
• Application Review and Audit: 1 to 1.5 months
• Query Resolution: 2 to 4 weeks

Total estimated duration: 3 to 4 months from start to finish

Government Fees and Costs for Class B Software Licensing

• Test License Fee: Included in application cost
• MD5 License Application Fee: INR 5000 per application
• Product Fees: INR 500 per product
• Testing Lab Charges: Vary by lab and test scope, typically INR 50,000 to 1,00,000
• Audit Fees: Usually borne by the applicant, negotiated with notified body

Budget realistically for approximately INR 1,50,000 to 2,50,000 in total costs, factoring in all components.

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to backlog at government-approved laboratories.

Solution: Engage early with testing labs to schedule tests, and consider private accredited labs if CDSCO-approved.

Challenge: Incomplete or inconsistent documentation leading to audit failures.

Solution: Utilize detailed checklists and expert consultation to prepare thorough Device and Plant Master Files.

Challenge: Uncertainty in risk management documentation.

Solution: Follow internationally recognized standards (ISO 14971) and maintain comprehensive records.

Expert Consultation and Support

Our extensive experience enables us to provide tailored support, including:

• End-to-end license application management
• Preparation of Device and Plant Master Files
• Coordination with notified bodies and testing laboratories
• Training on regulatory compliance

We have empowered over 500 companies to successfully navigate CDSCO licensing, minimizing delays and optimizing compliance.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal to access application forms and submission modules.
2. Conduct a detailed gap analysis of your current documentation and QMS against CDSCO requirements.
3. Engage with a CDSCO-approved testing laboratory promptly to schedule your product testing.
4. Prepare your Device and Plant Master Files using expert resources to ensure compliance.
5. Apply for the Test License (Form MD13) to initiate the formal process.
6. Plan for notified body audit by reviewing the list of notified bodies and engaging early.

Starting early and adopting a structured approach will significantly improve your chances of timely license approval. For personalized assistance, reach out to experienced regulatory consultants who understand the nuances of software medical devices.

Our team is ready to support your journey into the Indian market with confidence and compliance.