CDSCO License for In Vitro embryo culture medium, through day 3 of development

Introduction to In Vitro Embryo Culture Medium and Its Regulatory Importance

In vitro embryo culture medium, particularly through day 3 of development, plays a critical role in assisted reproductive technologies (ART). This medium supports human gamete and embryo manipulation, often containing medicinal substances like Gentamicin to ensure optimal embryo viability. Given its direct application in sensitive clinical procedures, regulatory compliance is paramount for safety, efficacy, and market access in India. Navigating the CDSCO licensing landscape for such Class C medical devices requires detailed understanding and strategic planning.

CDSCO Regulatory Framework for In Vitro Embryo Culture Medium

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulations in India under the Medical Device Rules, 2017. Devices like the In Vitro embryo culture medium fall under the Obstetrical and Gynecological category and are classified as Class C due to their moderate to high risk. Compliance with CDSCO ensures that the product meets India’s stringent safety and quality standards before entering the market.

Risk Classification and License Requirements for Class C Devices

Class C devices, such as the embryo culture medium, require a manufacturing license issued by the Central Licensing Authority (CLA) via the MD9 license (Form MD7). This is because of the device's critical application in human reproduction and inclusion of medicinal substances. The MD9 license process is more rigorous compared to Class A/B devices, involving comprehensive testing, documentation, and audits.

Manufacturing License Process (MD9) for Class C Embryo Culture Medium

Our extensive experience with 500+ companies has shown that the MD9 license process typically spans 4 to 5 months. Here’s a step-wise breakdown tailored for Class C embryo culture medium:

1. Test License (Form MD13): Apply for a test license that allows manufacturing samples for testing. This step takes approximately 1.5-2 months.
2. Product Testing: Conduct testing at CDSCO-recognized government-approved labs. Tests verify sterility, biocompatibility, and medicinal substance stability.
3. Documentation Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. Application Submission (Form MD7): Submit the MD9 license application through the CDSCO MD Online Portal.
5. Audit: CDSCO inspectors conduct an on-site audit covering manufacturing practices, quality management systems, and compliance.
6. Query Resolution: Address any queries raised by CDSCO or auditors promptly.
7. License Grant: Upon satisfactory review, the MD9 license is granted on Form MD9.

Manufacturing License Documents Required for MD9

For this Class C device, the following documents are essential:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File detailing formulation, composition, and manufacturing process (see our Device Master File guide)
• Plant Master File describing the manufacturing facility and equipment (Plant Master File guide)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File outlining hazard analysis and mitigation strategies (Risk Management resource)
• Test Reports from government-approved laboratories (Testing Laboratories list)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, typically ISO 13485 compliant

Import License Process (MD15) for In Vitro Embryo Culture Medium

If importing this device, an MD15 import license is mandatory, issued by the Central Licensing Authority. The process takes approximately 5 to 6 months and entails:

• Preparation of required documents including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files
• Submission of application on Form MD14 via the CDSCO MD Online Portal
• Review and query resolution
• License issuance on Form MD15

No test license is required for import license applications, but rigorous documentation and compliance proof are essential.

Import License Documents Required for MD15

Key documents include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate confirming market authorization
• ISO 13485:2016 Certification
• CE Certificate or equivalent quality marks
• Device Master File and Plant Master File
• Wholesale license in India
• Company Constitution documents

Government fees vary based on device classification, with Class C devices attracting fees of $3000 per site and$1500 per product.

Timeline and Processing Duration for Class C Embryo Culture Medium

Bear in mind that delays can occur due to incomplete documentation or audit scheduling. Early preparation reduces turnaround time.

Government Fees and Costs Breakdown

• MD9 Manufacturing License: Rs 50,000 per application + Rs 1,000 per product
• Test License (MD13): Included within manufacturing process costs
• MD15 Import License: USD 3,000 per site + USD 1,500 per product for Class C

Additional expenses include testing fees at government-approved labs and audit charges by notified bodies or CDSCO inspectors.

Common Challenges and Practical Solutions

Challenge: Delays due to incomplete or inconsistent documentation.

• Solution: Utilize detailed checklists and expert review to ensure all documents (such as Device Master File and Risk Management File) are complete and compliant.

Challenge: Difficulty in coordinating product testing at government-approved labs.

• Solution: Schedule testing early and select labs from the official Testing Laboratories list to avoid bottlenecks.

Challenge: Audit non-compliance findings.

• Solution: Conduct internal pre-audits and align QMS documentation with ISO 13485 standards before the CDSCO audit.

Challenge: Query resolution delays.

• Solution: Assign dedicated regulatory personnel to respond swiftly and accurately to CDSCO queries.

Expert Consultation and Support

With 25+ years of regulatory consulting experience and over 500 successful CDSCO license approvals, we provide end-to-end support. From initial risk classification assessment and document preparation to audit facilitation and query management, our expert team ensures a smooth pathway to market entry for your In Vitro embryo culture medium.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm Class C status as per the Medical Device Classification guide.
2. Prepare documentation: Start compiling your Device Master File, Plant Master File, and Risk Management Files early.
3. Apply for Test License (MD13): Initiate sample manufacturing and testing to comply with CDSCO requirements.
4. Engage with notified bodies: For audits, review the list of notified bodies authorized for Class C devices.
5. Submit manufacturing license application (MD9): Use the CDSCO MD Online Portal for streamlined processing.
6. Plan for audit and query responses: Prepare your team for inspections and prompt communication.

Starting early and leveraging expert guidance can significantly reduce approval time and costs. Contact us today to navigate your regulatory journey for In Vitro embryo culture medium with confidence.