CDSCO License for Software for ophthalmic surgery treatment planning

Comprehensive Guide to CDSCO Licensing for Software in Ophthalmic Surgery Treatment Planning (Class C)

When it comes to innovative medical software intended for ophthalmic surgical planning, securing the appropriate CDSCO license is critical to ensure regulatory compliance and market access in India. Our 25+ years of experience in medical device regulatory consulting has guided over 500 companies through this process, specifically for devices like your Class C software designed to simulate surgical outcomes based on ocular measurements.

Understanding Your Device: Software for Ophthalmic Surgery Treatment Planning

Your software assists surgeons by providing precise simulation results based on pre-surgical eye measurements, significantly aiding ophthalmic surgery treatment planning. Classified under risk Class C as per CDSCO guidelines and notified under 29/Misc./03/2020-DC (198) dated 13.9.2021, this device demands rigorous regulatory scrutiny due to its potential impact on patient safety.

CDSCO Regulatory Framework for Class C Software Medical Devices

The Central Drugs Standard Control Organization (CDSCO) governs the approval of such software under the Medical Device Rules, 2017. Being a Class C device, the licensing process falls under the Central Licensing Authority, requiring an MD9 manufacturing license application (Form MD7). This process ensures your software meets all essential principles, quality, safety, and performance standards before entering the Indian market.

Risk Classification and License Requirements

Class C devices carry a moderate-to-high risk, necessitating adherence to comprehensive documentation, product testing, and audits. The MD9 license process includes obtaining a test license (Form MD13) and subsequent product testing in government-approved laboratories.

For detailed classification, visit our Medical Device Classification guide.

Manufacturing License Process (MD9)

1. Test License Application (Form MD13): Initiate the process by applying for a test license, which takes approximately 1.5 to 2 months. This permits you to manufacture the software for testing purposes.

2. Product Testing: Conduct mandatory product testing at CDSCO-approved labs listed in the Testing Laboratories directory. For software, testing focuses on performance validation, cybersecurity, and compliance with relevant standards.

3. Documentation Preparation: Develop comprehensive dossiers including Device Master File and Plant Master File, incorporating quality management system documentation aligned with ISO 13485:2016.

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

5. Inspection and Audit: CDSCO officials conduct audits to verify compliance with regulatory requirements. Prepare for detailed scrutiny of your software development lifecycle, risk management, and post-market surveillance plans.

6. Query Resolution: Address any queries raised by the department promptly to avoid delays.

7. License Grant: Upon satisfactory evaluation, the MD9 license is granted, authorizing commercial manufacturing.

For comprehensive insights, consult our MD9 License Guide.

Manufacturing License Documents Required

• Company Constitution Proof (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Premises Ownership or Lease Agreement
• Details of Technical Staff (Qualifications and experience)
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed device description, design, manufacturing process, and software validation (see our Device Master File guide)
• Plant Master File: Infrastructure, equipment details, and quality assurance systems (Plant Master File guide)
• Essential Principles Checklist confirming compliance with regulatory standards
• Risk Management File: Documentation of risk analysis and mitigation strategies (Risk Management resource)
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents

Import License Process (MD15) for Ophthalmic Surgery Software

If you plan to import this Class C software, an MD15 import license is required, granted by the Central Licensing Authority. Although the import license is separate, having a valid manufacturing license or equivalent foreign certifications (ISO 13485, CE marking) is essential.

Steps include:

• Document Preparation (Manufacturing license, Free Sale Certificate, CE Certificates, ISO 13485:2016)
• Submission of MD15 application (Form MD14) via the CDSCO MD Online Portal
• Queries resolution
• Grant of license

More details can be found in our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution Proof

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 2 months (depending on lab availability and complexity)
• MD9 License Processing: 1.5 to 2 months
• Total Duration: Approximately 4 to 5 months from start to finish

Delays often arise from incomplete documentation or delays in audit scheduling. Planning ahead and ensuring thorough documentation can help keep the process on track.

Government Fees and Costs

• Test License (MD13): Included in application fees
• MD9 License Application Fee: Rs 50,000 per application
• Per Product Fee: Rs 1,000 per software product
• Additional costs may include testing lab fees and audit charges

Common Challenges and Solutions

Challenge: Incomplete or inconsistent documentation leading to delays.

Solution: Implement a document checklist early and leverage expert consultants to review submissions.

Challenge: Delays in scheduling audits and inspections.

Solution: Maintain proactive communication with CDSCO and notified bodies. Prepare all QMS and technical files meticulously.

Challenge: Meeting software-specific testing requirements.

Solution: Engage CDSCO-approved test labs experienced in medical software validation.

Expert Consultation and Support

With over two decades of industry expertise, we provide end-to-end regulatory consulting services, from gap analysis, documentation preparation, to audit readiness and submission support. Our tailored approach ensures your ophthalmic surgery planning software meets all regulatory mandates efficiently.

Getting Started with Your CDSCO License Application

1. Conduct a Regulatory Gap Assessment: Evaluate your current documentation and processes against CDSCO requirements.
2. Develop Your Device and Plant Master Files: Ensure detailed and compliant technical documentation.
3. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
4. Coordinate Testing with Approved Labs: Schedule testing early to fit within your timeline.
5. Prepare and Submit MD9 Application (Form MD7): Post successful testing, proceed with the main manufacturing license application.
6. Plan for Audit and Inspection: Train your team and organize documents for a smooth audit.
7. Address Queries Promptly: Expedite resolution to avoid unnecessary delays.

For hands-on assistance, connect with our regulatory experts who specialize in medical device software compliance. Our proven track record can help you navigate the process smoothly and bring your ophthalmic surgical planning software to the Indian market successfully.