CDSCO License for Preservation medium for human semen
Medical Device Information
Intended Use
It is intended for cryopreservation of human semen for later use in Assisted Reproductive procedure. It may include medicinal and biological components like glycerol, gentamicin, Test Yolk Buffer (TYB),etc.
Introduction to Preservation Medium for Human Semen and Its Regulatory Importance
The preservation medium for human semen plays a critical role in assisted reproductive technologies (ART) by ensuring the viability of semen during cryopreservation. This medium typically contains medicinal and biological components such as glycerol, gentamicin, and Test Yolk Buffer (TYB), providing a stable environment for storage and later use in fertility treatments. Given its direct application in obstetrical and gynecological procedures, regulatory compliance is essential to guarantee safety, efficacy, and quality.
In India, the Central Drugs Standard Control Organisation (CDSCO) governs the licensing of medical devices, including preservation media for human semen, under the Medical Device Rules, 2017. For manufacturers and importers aiming to enter the Indian market, understanding the CDSCO regulatory framework and licensing process is crucial for smooth market access.
CDSCO Regulatory Framework for Preservation Medium for Human Semen
This device falls under the Obstetrical and Gynecological category and bears the notification file number 29/Misc./03/2020-DC (181), dated 03.06.2022, issued by CDSCO. It is classified as a Class C medical device due to its intended use in assisted reproduction involving biological components.
Medical devices in India are regulated based on risk classification, with Class C devices requiring a stringent review process managed by the Central Licensing Authority. The regulatory pathway ensures comprehensive evaluation of product safety, quality, and manufacturing practices.
Risk Classification and License Requirements for Class C Devices
Class C devices are moderate-to-high risk and include products like preservation media for human semen. For such devices, manufacturers must obtain the MD9 manufacturing license, which is granted by the CDSCO Central Licensing Authority.
The MD9 license application is submitted via the CDSCO MD Online Portal and involves multiple stages, including obtaining a test license (Form MD13), product testing, document preparation, audit, and final license grant.
Manufacturing License Process (MD9) for Preservation Medium for Human Semen
The MD9 license process typically spans 4 to 5 months and involves the following steps:
Test License Application (Form MD13): Obtain a test license to manufacture the product for testing purposes. This step takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory testing in government-approved laboratories to demonstrate compliance with relevant standards. Testing labs can be identified through the Testing Laboratories list.
Document Preparation: Compile necessary documentation including Device Master File, Plant Master File, QMS documents, risk management files, and more.
Application Submission (Form MD7): Submit the manufacturing license application for MD9 on the CDSCO MD Online Portal.
Audit by CDSCO Inspectors: Undergo an on-site audit to verify compliance with Good Manufacturing Practices (GMP) and technical requirements.
Query Resolution: Address any queries raised by the CDSCO or auditors promptly.
Grant of License (Form MD9): Upon satisfactory compliance, the MD9 license is granted.
Manufacturing License Documents Required for MD9
For a Class C device like the preservation medium for human semen, the following documents are essential:
- Company Constitution Documents (e.g., Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement for manufacturing premises
- Details of Qualified Technical Staff including their qualifications and experience
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing device design, ingredients, manufacturing process, and specifications. Refer to our comprehensive Device Master File guide for preparation tips.
- Plant Master File (PMF) describing manufacturing facilities and equipment. Learn how to create an effective PMF in our Plant Master File guide.
- Essential Principles Compliance Checklist confirming conformity to medical device standards
- Risk Management File documenting risk analysis, mitigation strategies, and compliance with ISO 14971. Our Risk Management guide offers practical insights.
- Test Reports from approved laboratories
- Labels and Instructions for Use (IFU) compliant with CDSCO requirements
- Quality Management System (QMS) Documentation such as ISO 13485:2016 certification and SOPs
Import License Process (MD15) for Preservation Medium for Human Semen
If you are importing this device into India, an MD15 import license issued by the Central Licensing Authority is mandatory. The import license process generally takes 5 to 6 months and includes:
- Preparation of comprehensive documentation
- Submission of application on CDSCO MD Online Portal
- Resolution of any queries raised
- Final grant of the MD15 license
Unlike manufacturing licenses, no test license is required prior to application.
Import License Documents Required for MD15
Key documents include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate or equivalent
- ISO 13485:2016 Quality Management System certification
- CE Certificate or equivalent conformity assessment
- Device Master File and Plant Master File
- Wholesale License in India
- Company Constitution
The government fees vary by device class—Class C devices incur higher fees reflecting their risk profile.
Timeline and Processing Duration
| License Type | Processing Time | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5 – 2 months | Application, testing, and approval |
| MD9 License | 4 – 5 months | Document prep, audit, query resolution, license grant |
| MD15 Import License | 5 – 6 months | Document prep, query resolution, license grant |
Planning your project timeline with these estimates ensures realistic market entry expectations.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee | Notes |
|---|---|---|---|
| MD9 | Rs. 50,000 | Rs. 1,000/product | Central Authority License Fees |
| MD15 | $3,000 per site | $1,500 per product | Central Authority Import Fees |
Additional costs include laboratory testing, notified body audits, and consultant fees if applicable.
Common Challenges and Solutions
Delayed Testing Results: Government-approved labs often have long queues. Planning early and engaging multiple labs can reduce delays.
Incomplete Documentation: Missing or inconsistent documents cause query cycles. Using checklists and expert review ensures completeness.
Audit Non-Compliance: Prepare for audits by conducting internal mock audits and training staff on GMP practices.
Query Resolution Delays: Respond to CDSCO queries promptly and provide detailed, evidence-backed answers.
Understanding Risk Management: Many manufacturers underestimate the importance of a robust risk management file. Our Risk Management guide can help you implement compliant processes.
Expert Consultation and Support
With over 25 years of experience and having assisted 500+ companies, we specialize in navigating the CDSCO licensing maze for Class C devices like preservation media for human semen. Our services include:
- Gap analysis and regulatory strategy
- Preparation of Device and Plant Master Files
- End-to-end application filing on the CDSCO MD Online Portal
- Coordination with notified bodies and testing laboratories
- Audit readiness and mock inspections
- Efficient query management and follow-up
Our proven approach minimizes delays and maximizes compliance, accelerating your time to market.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your device’s Class C status using our Medical Device Classification guide.
Engage Testing Laboratories Early: Identify suitable government-approved labs from the Testing Laboratories list to schedule product testing.
Prepare Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management File using our comprehensive guides.
Apply for Test License (Form MD13): Submit your test license application via the CDSCO MD Online Portal.
Plan for Audit and QMS Implementation: Ensure your manufacturing site complies with ISO 13485 and GMP requirements ahead of the CDSCO audit.
Consult Experts: Consider partnering with experienced regulatory consultants to streamline your licensing journey and avoid common pitfalls.
By following these actionable steps, manufacturers and importers can confidently navigate the CDSCO licensing process for the preservation medium for human semen, ensuring regulatory compliance and successful market entry in India.
