CDSCO License for Software for active implanted device control

Comprehensive Guide to CDSCO Licensing for Software for Active Implanted Device Control (Class C)

As specialists with over 25 years of experience in medical device regulatory affairs, we have assisted more than 500 companies in navigating the complexities of obtaining CDSCO licenses. This guide provides a detailed roadmap tailored for manufacturers and importers of software for active implanted device control, a Class C medical device software in India.

Understanding the Device and Regulatory Importance

The device in question is a software used to transmit one or more electrical operating characteristics noninvasively to the active base unit and change those characteristics. Given its critical role in controlling active implanted devices, it is classified as a Class C medical device software under the CDSCO framework. This classification mandates stringent regulatory compliance to ensure safety, performance, and efficacy before market entry.

CDSCO Regulatory Framework for Software Medical Devices

In India, medical device software falls under the purview of the Central Drugs Standard Control Organization (CDSCO). The regulatory framework mandates:

• Risk-based classification (Class A to D)
• Licenses issued by either State or Central Licensing Authorities
• Compliance with Quality Management System (QMS) standards such as ISO 13485:2016
• Submission of comprehensive technical documentation

For Class C devices like this software, the MD9 manufacturing license is mandatory, regulated by the Central Licensing Authority.

Risk Classification and License Requirements for Class C Software

Class C devices represent moderate to high risk and include software that actively controls implanted devices. As per the CDSCO notification 29/Misc./03/2020-DC (198) dated 13.9.2021, this software mandates:

• MD9 License Application (Form MD7)
• Compliance with essential principles outlined by CDSCO
• Submission of risk management files demonstrating hazard analysis and mitigation

For detailed classification insight, you may refer to our Medical Device Classification resource.

Manufacturing License Process (MD9) for Class C Software

The process for obtaining the MD9 license for Class C software involves several critical steps:

1. Test License on Form MD13: Before applying for the MD9 license, manufacturers must obtain a test license, which takes approximately 1.5 to 2 months. This allows for product testing in government-approved laboratories.

2. Product Testing: The device must undergo rigorous testing at CDSCO-approved labs to validate safety and performance. You can find the list of government-approved Testing Laboratories here.

3. Documentation Preparation: Compile all necessary technical and quality documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS documentation.

4. License Application Submission: Submit the MD9 license application (Form MD7) through the CDSCO MD Online Portal.

5. Audit and Inspection: CDSCO inspectors conduct a thorough audit of manufacturing facilities and documentation compliance.

6. Queries and Responses: Address any queries raised by the department or inspectors promptly.

7. Grant of MD9 Manufacturing License: Upon satisfactory review and audit, CDSCO issues the MD9 license.

For a deep dive into the MD9 licensing process, our MD9 License Guide offers comprehensive insights.

Manufacturing License Documents Required for Class C Software

Successful MD9 license applications require meticulous documentation, including but not limited to:

• Company Constitution and Incorporation Proof
• Ownership proof of manufacturing premises
• Technical staff qualifications and experience certificates
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed technical specifications and design controls. Our Device Master File guide explains preparation.
• Plant Master File (PMF): Manufacturing facility details and quality systems. Learn more via our Plant Master File Guide.
• Essential Principles Checklist: Compliance matrix confirming adherence to CDSCO essential principles.
• Risk Management File: Documentation of risk analysis, mitigation strategies consistent with ISO 14971. See our resource on Risk Management.
• Test Reports: Certified test reports from CDSCO-approved testing labs.
• Labels and Instructions for Use (IFU)
• Quality Management System Documents: ISO 13485:2016 certification and internal procedures.

Import License Process (MD15) for Class C Software

If you are importing this software into India, the MD15 import license is mandatory. The process is slightly different:

• No test license required
• Submit application on Form MD14 via the CDSCO MD Online Portal
• Provide required documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, Wholesale License, and Company Constitution
• CDSCO reviews and may raise queries
• License issuance typically takes 5 to 6 months

Refer to our detailed Import License Guide for step-by-step assistance.

Timeline and Processing Duration

Government Fees and Costs

Additional costs to consider:

• Testing laboratory fees (vary by lab and test complexity)
• Audit fees (if applicable)
• Consultancy fees for documentation and application assistance

Common Challenges and Practical Solutions

• Delayed Test Reports: Coordinate early with notified testing labs to schedule tests promptly.
• Incomplete Documentation: Use checklists and templates from experienced consultants to avoid rejections.
• Audit Non-Compliance: Conduct internal pre-audits to ensure your QMS and facility meet CDSCO expectations.
• Query Response Delays: Assign dedicated regulatory personnel for timely correspondence.

Expert Consultation and Support

Navigating CDSCO licensing for Class C software requires detailed understanding and precise execution. Our team offers:

• End-to-end regulatory consulting
• Document preparation and review
• Liaison with CDSCO and notified bodies
• Pre-audit readiness assessments

Our proven track record with 500+ successful licenses ensures you minimize risks and expedite market entry.

Getting Started with Your CDSCO License Application

To initiate your licensing journey:

1. Assess Device Classification and Confirm Regulatory Path
2. Prepare and Submit Test License Application (Form MD13) via the CDSCO MD Online Portal
3. Schedule Testing with Government-Approved Labs (Testing Laboratories)
4. Compile Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist
5. Prepare your Quality Management System aligned with ISO 13485:2016
6. Submit MD9 License Application (Form MD7)
7. Schedule and Prepare for CDSCO Inspection
8. Respond promptly to departmental queries

Starting early and partnering with experienced regulatory consultants can save valuable time and resources. For a personalized consultation, feel free to reach out to our experts who specialize in Class C medical device software licensing in India.

Embark confidently on your regulatory pathway with a trusted partner committed to your success in the Indian medical device market.