CDSCO License for Diagnostic supporting software for diabetes

Introduction to Diagnostic Supporting Software for Diabetes and Its Regulatory Significance

Diagnostic supporting software for diabetes plays a critical role in modern healthcare by assisting clinicians and patients in analyzing blood glucose data to optimize therapeutic outcomes. As a software device intended to process and interpret blood glucose meter data, this product falls under the purview of medical device regulations in India. Ensuring compliance with the Central Drugs Standard Control Organization (CDSCO) licensing framework is essential for market access, patient safety, and regulatory adherence.

With over 25 years of experience and having supported more than 500 companies, we understand the nuances involved in navigating the CDSCO licensing process for Class B medical devices such as diabetes diagnostic software. This comprehensive guide provides actionable insights, timelines, costs, and document requirements tailored specifically for your device.

CDSCO Regulatory Framework for Diagnostic Supporting Software for Diabetes

India regulates medical devices under the Medical Device Rules (MDR) 2017, administered by CDSCO. The regulatory framework classifies devices based on risk, intended use, and complexity. Software devices like diagnostic supporting software for diabetes are recognized as medical devices requiring specific licenses before manufacturing or import.

Your device is notified under the official gazette notification number 29/Misc./03/2020-DC (198) dated 13.09.2021, which explicitly includes software devices supporting diabetes therapy as regulated medical devices. Therefore, regulatory compliance is mandatory.

Risk Classification and License Requirements

According to CDSCO's classification guidelines, diagnostic supporting software for diabetes is assigned as a Class B medical device. Class B devices are considered low to moderate risk, and thus, the manufacturing license falls under the MD5 license category.

• Risk Class: B
• Applicable License: MD5 (Manufacturing License for Class A & B devices)
• Licensing Authority: State Licensing Authority

For importers, the corresponding license is MD15.

Learn more about medical device classification to understand the nuances.

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process for manufacturing Class B diagnostic software involves several stages:

1. Test License Application (Form MD13): Before applying for MD5, obtain a test license to conduct product testing. This stage typically takes 1.5 to 2 months.
2. Product Testing: Submit the software for testing at CDSCO-approved laboratories to verify compliance with applicable standards.
3. Document Preparation: Compile technical documentation including Device Master File and Plant Master File.
4. Application Submission (Form MD3): Apply online via the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: Undergo an audit by an approved notified body to evaluate manufacturing processes and quality management systems.
6. Query Resolution: Address any queries raised by the licensing authority or notified body.
7. License Grant (Form MD5): Upon successful review and audit, receive the manufacturing license.

Detailed guidance on the MD5 license process is available in our MD5 License Guide.

Manufacturing License Documents Required

For a Class B software device like diagnostic supporting software for diabetes, the document submission is critical. Typical documents include:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualification Proofs of Technical Staff
• Fire Safety No Objection Certificate (NOC)
• Pollution Control Board NOC (if applicable)
• Device Master File (DMF): Detailed technical documentation about the software, its design, functionality, validation, and updates. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF): Documentation about manufacturing facilities and processes. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist aligned with MDR 2017
• Risk Management File demonstrating compliance with ISO 14971 standards. Practical tips on risk management are available.
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Ensure all documents are current, accurate, and tailored to the software's intended use.

Import License Process (MD15) for Diagnostic Supporting Software

If you are an importer rather than a manufacturer, obtaining an MD15 license from the Central Licensing Authority is mandatory. The process includes:

1. Document compilation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate (if applicable), Device Master File, and Plant Master File.
2. Submission of application via Form MD14 on the CDSCO MD Online Portal.
3. Queries resolution and compliance verification by CDSCO.
4. Issuance of Import License (Form MD15).

For detailed import licensing procedures, refer to our comprehensive Import License Guide.

Import License Documents Required

Key documents for import include:

• Manufacturing License from the original manufacturer
• Free Sale Certificate issued by the country of origin
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents

Ensuring these documents meet CDSCO's expectations expedites the approval process.

Timeline and Processing Duration

For your Class B diagnostic supporting software:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months depending on lab scheduling
• MD5 License Application Processing: Approximately 1.5 to 2 months

Total estimated duration: 3 to 4 months from test license application to license grant.

For import licenses (MD15), the process typically takes 5 to 6 months.

Government Fees and Costs

The fee structure for Class B devices under the MD5 license is as follows:

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs may include testing fees at government-approved labs and notified body audit charges.

For imports under MD15, fees vary by class and product count; consult the CDSCO portal for current rates.

Common Challenges and Solutions

Manufacturers and importers often face these challenges:

• Document Gaps: Missing or incomplete Device Master Files and Risk Management documentation can delay approvals. Our document templates and expert review services can mitigate this.
• Testing Delays: Limited slots at CDSCO-approved laboratories may cause bottlenecks. Early scheduling and choosing labs from the CDSCO Testing Laboratories list can help.
• Audit Non-Compliance: Not adhering to quality management system requirements leads to audit failures. Conduct internal audits and pre-assessments before notified body visits.
• Query Resolution Delays: Prompt responses to CDSCO queries are essential; appoint a dedicated regulatory liaison to manage communications.

Expert Consultation and Support

Our team has successfully navigated regulatory pathways for over 500 companies in India, specializing in software medical devices including diagnostic supporting software for diabetes. We offer:

• Gap analysis of your current documentation
• Preparation of Device Master Files and Risk Management files
• Liaison with notified bodies and CDSCO officials
• End-to-end application filing and follow-up

Partnering with experienced consultants reduces time-to-market and ensures compliance.

Getting Started with Your CDSCO License Application

Here's how to begin:

1. Assess your Device Classification: Confirm your device falls under Class B as per the notification.
2. Prepare Documentation: Initiate development of Device Master File, Plant Master File, and Risk Management File.
3. Apply for Test License (Form MD13): Submit your application on the CDSCO MD Online Portal to begin the testing phase.
4. Schedule Product Testing: Engage CDSCO-approved labs early to avoid delays.
5. Coordinate with a Notified Body: Identify and connect with an approved notified body from the Notified Bodies List.
6. Prepare for Audit: Align your QMS and facilities to meet audit requirements.
7. Submit Manufacturing License Application (Form MD3): After successful testing and preparation, apply for the MD5 license.

Taking these proactive steps will streamline your path to regulatory approval and successful market entry in India. For personalized guidance, contact our regulatory experts today.

By following this detailed roadmap, manufacturers and importers of diagnostic supporting software for diabetes can confidently navigate the CDSCO licensing process, ensuring compliance and accelerating time to market.