CDSCO License for Gamete and embryo retrieval, storage and transfer medium

Comprehensive Guide to CDSCO Licensing for Gamete and Embryo Retrieval, Storage, and Transfer Medium

As a critical component in assisted reproductive procedures, the Gamete and Embryo Retrieval, Storage, and Transfer Medium plays a pivotal role in ensuring the physiological integrity of human gametes and embryos during retrieval, culture, transport, and transfer. Classified as a Class C medical device under the CDSCO medical device classification, this device demands stringent regulatory compliance due to its direct involvement in reproductive health.

With over 25 years of experience and having supported 500+ companies in navigating CDSCO licensing, we provide a detailed walkthrough of the regulatory requirements, timelines, costs, and documentation essential for manufacturers and importers targeting the Indian market.

CDSCO Regulatory Framework for Gamete and Embryo Retrieval Medium

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices in India, ensuring safety, efficacy, and quality. For devices like the Gamete and Embryo Retrieval Medium categorized under Obstetrical and Gynecological devices, the CDSCO mandates compliance with the Medical Device Rules, 2017, and subsequent amendments.

Given the device’s classification as Class C, regulatory oversight is centralized under the CDSCO Central Licensing Authority for manufacturing and import licensing.

Risk Classification and License Requirements

• Risk Class: C
• Regulatory Implication: Requires a manufacturing license under form MD9 (application form MD7) and an import license under form MD15.

Class C devices are considered moderate to high risk, necessitating rigorous evaluation including product testing, documentation audits, and factory inspections.

Manufacturing License Process for Class C Devices (MD9 License)

Step 1: Test License (Form MD13)

Before applying for the manufacturing license, applicants must obtain a Test License on Form MD13. This license allows sample products to be tested in CDSCO-approved labs.

• Timeline: Approximately 1.5 to 2 months
• Testing: Conducted by government-approved laboratories listed on the CDSCO Testing Laboratories portal

Step 2: Product Testing

Samples of the gamete and embryo medium, including any medicinal substances like Gentamicin, must undergo rigorous testing to verify compliance with safety and performance standards.

Step 3: License Application Submission (Form MD7)

Once test reports are available, the manufacturer submits the application for the MD9 license via the CDSCO MD Online Portal. This application includes comprehensive documentation and evidence of compliance.

Step 4: CDSCO Inspection and Audit

CDSCO inspectors conduct a thorough audit of the manufacturing facility, quality systems, and documentation. They verify compliance with Good Manufacturing Practices (GMP) and the Medical Device Rules.

Step 5: Query Resolution and Final Approval

The applicant responds to any queries raised by CDSCO during the audit process. Upon satisfactory resolution, the MD9 manufacturing license is granted.

• Total Processing Time: Approximately 4 to 5 months from test license application
• Fees: Rs. 50,000 per application + Rs. 1,000 per product

For a detailed process overview, refer to our MD9 License Guide.

Manufacturing License Documents Required for Gamete and Embryo Medium

To ensure a smooth application process, prepare the following key documents:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing formulation, composition, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facility and equipment (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File including hazard analysis and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents, preferably ISO 13485:2016 certification

Preparing these documents meticulously reduces the chances of delays during audits and reviews.

Import License Process for Class C Devices (MD15 License)

For importers intending to bring the Gamete and Embryo Retrieval Medium into India, an MD15 license is mandatory.

Key Steps:

1. Document Preparation: Collect all required documents including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device and Plant Master Files.

2. Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution: Respond promptly to any CDSCO queries.

4. License Grant: Upon successful review, the MD15 import license is issued.

• Timeline: 5 to 6 months
• Fees: For Class C devices, Rs. 3,000 per site + Rs. 1,500 per product

Learn more from our Import License Guide.

Timeline and Processing Duration Summary

Adequate planning is crucial to align product launch timelines with regulatory approvals.

Government Fees and Costs

Note: Additional costs may include notified body audit fees, testing charges, and consulting fees.

Common Challenges and Practical Solutions

Challenge 1: Delays in Test License and Product Testing

Solution: Engage with CDSCO-approved labs early and prepare sample batches meticulously to avoid retesting.

Challenge 2: Incomplete or Non-compliant Documentation

Solution: Use expert-reviewed templates for Device and Plant Master Files; ensure your QMS is robust and aligned with ISO 13485 standards.

Challenge 3: Audit Non-conformities

Solution: Pre-audit your facility and processes with experienced consultants to identify gaps before CDSCO inspection.

Challenge 4: Query Resolution Delays

Solution: Assign dedicated regulatory personnel to respond promptly and accurately to CDSCO queries to avoid prolonged processing.

Expert Consultation and Support

Navigating CDSCO regulations for Class C devices such as Gamete and Embryo Medium requires expertise. Our team with 25+ years of regulatory consulting experience offers:

• End-to-end application preparation
• Device and Plant Master File development
• Pre-audit and mock audit services
• Liaison with CDSCO and notified bodies
• Training on compliance and documentation

Partnering with experts minimizes risks and accelerates market entry.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class C designation for your gamete and embryo medium.

2. Initiate Test License Application: Prepare sample lots and submit Form MD13 via the CDSCO MD Online Portal.

3. Engage Approved Testing Labs: Coordinate with CDSCO-listed labs for timely testing (Testing Laboratories).

4. Compile Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and Essential Principles checklist.

5. Submit Manufacturing License Application: Apply for the MD9 license using Form MD7 online.

6. Prepare for Audits: Conduct internal audits and address any gaps before CDSCO inspection.

7. For Importers: Assemble all required import documentation and apply for MD15 license.

By following this structured approach, manufacturers and importers can confidently navigate the CDSCO licensing process for the Gamete and Embryo Retrieval, Storage, and Transfer Medium, ensuring compliance and timely market access.

For personalized support and detailed project planning, contact us to leverage our expertise in successful CDSCO licensing.