CDSCO License for Device, Fertility Diagnostic, Contraceptive, Software Application

Comprehensive Guide to CDSCO Licensing for Fertility Diagnostic Contraceptive Software (Class C Medical Device)

As a company specializing in regulatory consulting with over 25 years of experience and having successfully assisted 500+ clients in navigating the CDSCO licensing landscape, we understand the unique challenges manufacturers and importers face in India. This guide focuses on the specific regulatory requirements for obtaining a CDSCO license for your Class C medical device: a Fertility Diagnostic, Contraceptive Software Application, designed to monitor fertility and prevent pregnancy.

Understanding Your Device and Its Regulatory Importance

Your device, classified under Class C as per the CDSCO notification 29/Misc./03/2020-DC (198) dated 13.09.2021, is a software application that plays a critical role in contraception by providing fertility monitoring and information. Such devices impact patient safety and thus require stringent regulatory oversight.

Compliance with CDSCO regulations ensures your device meets India’s safety, efficacy, and quality standards, enabling market access and building trust among healthcare providers and end-users.

CDSCO Regulatory Framework for Fertility Diagnostic Contraceptive Software

India classifies medical devices into four risk classes: A, B, C, and D, with Class C indicating a moderate to high risk. Software devices with contraceptive intent fall under Class C, hence subject to central licensing authority oversight.

Your device must comply with the comprehensive framework covering:

• Device registration and licensing
• Clinical evaluation (if applicable)
• Quality management systems aligned with ISO 13485
• Risk management per ISO 14971
• Post-market surveillance

For detailed classification, refer to the Medical Device Classification guide.

Risk Classification and License Requirements for Your Device

Given the Class C status, you are required to obtain an MD9 Manufacturing License if you plan to manufacture in India, or an MD15 Import License if importing the software device.

• MD9 License: Issued by the Central Licensing Authority, required for Class C/D manufacturing.
• MD15 License: Issued by the Central Licensing Authority, required for importing Class C/D devices.

Both licenses involve rigorous documentation, product testing, and inspections.

Manufacturing License Process (MD9) for Class C Software Devices

The MD9 license process typically spans 4-5 months and involves these stages:

1. Test License (Form MD13): Required before applying for MD9; takes approximately 1.5-2 months.
2. Product Testing: Conducted at CDSCO-approved laboratories to verify compliance.
3. Document Preparation: Comprehensive dossier including technical, quality, and risk management documents.
4. Application Submission (Form MD7): Filed via the CDSCO MD Online Portal.
5. Inspection and Audit: Performed by CDSCO officials to verify manufacturing compliance.
6. Query Resolution: Addressing any observations or clarifications.
7. License Grant (Form MD9): Upon satisfactory review and audit.

For a detailed walkthrough, our MD9 License Guide provides actionable insights.

Manufacturing License Documents Required

Precise documentation accelerates approval. For your Class C software device, key documents include:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Qualified Technical Staff (with qualifications and experience)
• No Objection Certificates (Fire Safety, Pollution Control)
• Device Master File (DMF) detailing device specifications and design (Device Master File guide)
• Plant Master File (PMF) outlining manufacturing facilities and processes (Plant Master File guide)
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File per ISO 14971 standards (Risk Management resource)
• Test Reports from CDSCO-approved labs (Testing Laboratories list)
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 certification preferred)

Import License Process (MD15) for Class C Software Devices

Importers must obtain an MD15 license from the Central Licensing Authority. The process is generally 5-6 months and includes:

1. Document Preparation: Compiling manufacturing license, Free Sale Certificate, CE Certificate, ISO 13485 certification, Device and Plant Master Files, Wholesale License, and company incorporation documents.
2. Application Submission (Form MD14): Via the CDSCO MD Online Portal.
3. Review and Queries: CDSCO may ask for clarifications.
4. License Issuance (Form MD15): Upon successful review.

For detailed procedural steps, consult our Import License Guide.

Import License Documents Required

• Valid Manufacturing License of the exporting company
• Free Sale Certificate issued by the competent authority of the exporting country
• ISO 13485:2016 certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Incorporation Certificate

Timeline and Processing Duration

Government Fees and Costs

MD9 Manufacturing License

• Application Fee: ₹50,000
• Per Product Fee: ₹1,000

MD15 Import License (Class C/D devices)

• Site Fee: $3,000 (~₹2,40,000)
• Per Product Fee: $1,500 (~₹1,20,000)

Note: Fees are subject to periodic revision by CDSCO. Plan budgets accordingly.

Common Challenges and Solutions

Challenge 1: Incomplete Documentation

Many applicants face delays due to insufficient or inconsistent documentation. We recommend early preparation of the Device and Plant Master Files, risk management documentation, and QMS records.

Challenge 2: Testing Delays

Testing at government-approved labs can be a bottleneck. Schedule testing in advance and choose labs with shorter lead times by consulting the Testing Laboratories list.

Challenge 3: Audit Non-compliance

Audit failures often arise from gaps in facility infrastructure or staff qualification records. Pre-audit self-assessments and mock audits can mitigate this risk.

Challenge 4: Query Resolution Delays

Timely and precise responses to CDSCO queries avoid prolonged processing. Maintain a dedicated regulatory team or partner with experienced consultants.

Expert Consultation and Support

Navigating the CDSCO regulatory landscape requires in-depth knowledge and experience. We provide end-to-end support:

• Gap analysis and readiness assessment
• Customized document preparation
• Coordination with notified bodies and testing labs
• Audit preparation and accompaniment
• Query management and liaison with CDSCO

Our track record of over 500 successful CDSCO licenses underscores our commitment to quality and compliance.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class C status and applicable regulatory pathways.
2. Collect and Prepare Documentation: Begin compiling your Device Master File, Plant Master File, risk management files, and other essential documents.
3. Apply for Test License (MD13): Submit your application through the CDSCO MD Online Portal to initiate the process.
4. Plan Product Testing: Schedule testing at CDSCO-approved laboratories early to avoid delays.
5. Engage with a Regulatory Consultant: Expert guidance can streamline your application and audit process.
6. Submit MD9 or MD15 Application: Once test license and testing are complete, file your manufacturing or import license application.

Embarking on this regulatory journey with meticulous planning and expert support can significantly enhance your chances of timely approval and successful market entry.

For further assistance and tailored consultancy, please contact our regulatory experts who specialize in medical device licensing and compliance.

Note: This content is designed for manufacturers and importers of Class C medical devices, specifically fertility diagnostic contraceptive software applications, seeking CDSCO licensing in India.