CDSCO License for Sperm  cryopreservation medium

Comprehensive Guide to CDSCO Licensing for Sperm Cryopreservation Medium (Class C Device)

At our firm, with over 25 years of experience and having supported 500+ medical device companies, we understand the nuances of navigating CDSCO licensing, especially for specialized devices like the Sperm Cryopreservation Medium. This product, classified as a Class C medical device under the Obstetrical and Gynecological category, plays a critical role in assisted reproductive technologies by facilitating the cryopreservation and storage of semen.

Understanding the Regulatory Importance of Sperm Cryopreservation Medium

Given its intended use in Assisted Reproductive Procedures, the Sperm Cryopreservation Medium is subject to rigorous regulatory oversight to ensure patient safety and product efficacy. India’s Central Drugs Standard Control Organization (CDSCO) mandates comprehensive evaluation and licensing before such devices can be marketed or imported.

CDSCO Regulatory Framework for Class C Medical Devices

The CDSCO classifies medical devices into four risk categories: Class A (low risk), B (low moderate risk), C (moderate high risk), and D (high risk). Your device falls under Class C, meaning it requires a centralized approval process through the CDSCO Central Licensing Authority.

As a Class C device, the Sperm Cryopreservation Medium requires an MD9 manufacturing license for domestic production or an MD15 import license if imported. Both licensing paths involve stringent documentation, testing, and audits to comply with Indian regulatory standards.

Risk Classification and License Requirements for Sperm Cryopreservation Medium

• Risk Class: C
• License Type: MD9 (Manufacturing License) or MD15 (Import License)
• Regulatory Authority: CDSCO Central Licensing Authority
• Notification Number: File No. 29/Misc./03/2020-DC (181)
• Notification Date: 03.06.2022

Detailed Manufacturing License Process (MD9) for Class C Devices

The MD9 license process is robust and involves several critical steps:

1. Test License Application (Form MD13): Before the manufacturing license, you must obtain a test license to conduct product testing. This typically takes 1.5 to 2 months.

2. Product Testing: The Sperm Cryopreservation Medium must be tested at CDSCO-recognized laboratories to ensure it meets safety and performance standards. Refer to the list of testing laboratories approved by CDSCO.

3. Document Preparation: Comprehensive technical and quality documentation must be prepared, including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Application Submission: Submit the manufacturing license application using Form MD7 via the CDSCO MD Online Portal.

5. Audits and Inspections: CDSCO inspectors will conduct audits of your manufacturing site and QMS to verify compliance.

6. Queries and Responses: Address any queries raised by CDSCO promptly to avoid delays.

7. License Grant: Upon satisfactory evaluation, the MD9 license (Form MD9) will be granted, allowing commercial manufacturing.

For a detailed walkthrough, our MD9 License Guide offers invaluable insights.

Manufacturing License Documents Required for Sperm Cryopreservation Medium

Prepare the following documents meticulously:

• Company Constitution Certificate (Incorporation documents)
• Proof of Ownership or Lease Agreement of manufacturing premises
• Technical Staff Qualification and Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing product specifications and design controls (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing processes and facilities (Plant Master File Guide)
• Essential Principles Checklist demonstrating conformity to safety and performance requirements
• Risk Management File documenting risk analysis and mitigation strategies (Risk Management)
• Test Reports from CDSCO-recognized labs
• Labels, Instructions for Use (IFU), and Packaging Details
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Import License Process (MD15) for Sperm Cryopreservation Medium

If you are importing this Class C device, the MD15 import license is mandatory, issued by the Central Licensing Authority. The process includes:

1. Document Compilation: Gather all required documentation including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate (if applicable), ISO 13485:2016 certification, device and plant master files, and wholesale license.

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

3. Review and Clarifications: CDSCO reviews your documents and may raise queries.

4. Grant of License: Following satisfactory assessment, the MD15 import license is issued.

More information is available in our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate confirming domestic marketing
• ISO 13485:2016 Quality Management System certificate
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale License for distribution in India
• Company Constitution Certificate

Timeline and Processing Duration for Class C Devices

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months (depends on lab workload)
• Document Preparation: Concurrent with testing, 1 to 2 months
• MD9 License Application and Review: Approximately 2 months

Total duration: Approximately 4 to 5 months from start to finish.

Government Fees and Cost Structure

• MD9 Application Fee: Rs. 50,000 per application
• Per Product Fee: Rs. 1,000 for each device variant
• Testing Fees: Variable, depending on the testing laboratory and tests required

Budgeting for these fees upfront is essential to avoid financial surprises.

Common Challenges and Practical Solutions

Challenge: Delays due to incomplete documentation or non-compliance with CDSCO requirements.

Solution: Engage experienced regulatory consultants early to review your documents. Maintain rigorous internal audit processes.

Challenge: Prolonged product testing timelines due to limited testing lab capacity.

Solution: Plan testing well in advance and coordinate with multiple approved labs listed on the CDSCO Testing Laboratories page.

Challenge: Audit non-conformities during site inspections.

Solution: Implement a robust QMS (preferably ISO 13485:2016 certified) and conduct mock audits before official inspections.

Expert Consultation and Support

With over two decades of regulatory expertise, we assist manufacturers and importers through every step of the CDSCO licensing journey—from initial classification to final license grant. Our tailored approach ensures compliance, reduces timelines, and mitigates risks.

Getting Started with Your CDSCO License Application for Sperm Cryopreservation Medium

1. Device Classification Confirmation: Verify your device’s Class C status using trusted resources like the Medical Device Classification guide.

2. Initial Documentation Audit: Prepare and organize your DMF, PMF, and QMS documents.

3. Apply for Test License: Submit Form MD13 on the CDSCO MD Online Portal to initiate product testing.

4. Coordinate Product Testing: Engage with CDSCO-approved labs early.

5. Prepare for Audit: Schedule and conduct internal audits aligning with CDSCO standards.

6. Submit Manufacturing License Application: Once testing is complete, file Form MD7 to apply for the MD9 license.

7. Follow-up and Query Resolution: Respond promptly to any CDSCO queries.

Taking these actionable steps with expert support maximizes your chances of timely approval, enabling you to launch your Sperm Cryopreservation Medium in India’s competitive assisted reproductive technology market efficiently and compliantly.