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CDSCO License for In Vitro embryo Culture medium, through day 5/6 of development

Medical Device Information

Device Class
Class C

Intended Use

It is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. It is used as a culture medium for human gametes and embryos from fertilization through day 5/6 of development. It may include medicinal substance like Gentamicin and protein supplement like Human serum Albumin (HSA), etc.

Manufacturing License
MD9
Import License
MD15
CDSCO License for In Vitro embryo Culture medium, through day 5/6 of development

Regulatory Compliance for In Vitro Embryo Culture Medium (Class C Medical Device)

In the rapidly evolving field of assisted reproductive technologies, the In Vitro Embryo Culture Medium (through day 5/6 of development) plays a critical role. This specialized culture medium supports human gametes and embryos during the crucial early stages of development, including fertilization up to day 5 or 6, often supplemented with medicinal substances like Gentamicin and protein additives such as Human Serum Albumin (HSA). Given its intimate contact with human gametes and embryos, regulatory compliance is not just a formality but a necessity to ensure safety and efficacy.

As an experienced regulatory consulting firm with over 25 years of expertise helping 500+ companies navigate the Indian market, we provide a detailed roadmap for manufacturers and importers aiming to secure CDSCO licensing for this Class C obstetrical and gynecological medical device.


CDSCO Regulatory Framework for In Vitro Embryo Culture Medium

The Central Drugs Standard Control Organization (CDSCO) governs the regulatory landscape for medical devices in India, including those used in reproductive medicine. Since the device falls under Class C (moderate to high risk), it is subject to stringent controls and must obtain the MD9 manufacturing license when manufactured domestically or the MD15 import license if imported.

This device is also covered under the CDSCO notification File No. 29/Misc./03/2020-DC (181) dated 03.06.2022, which classifies it under the Obstetrical and Gynecological category.

For full classification details and risk management insights, manufacturers should consult the Medical Device Classification guide and Risk Management.


Risk Classification and License Requirements

  • Device: In Vitro Embryo Culture Medium (day 5/6)
  • Risk Class: C
  • License Type: MD9 (Manufacturing License) for Class C devices
  • Licensing Authority: CDSCO Central Licensing Authority (CLA)

The MD9 license is mandatory for manufacturing Class C devices in India. For importers, the MD15 import license applies.


Manufacturing License Process (MD9) for Class C Devices

The MD9 license process is comprehensive and typically spans 4 to 5 months. Here is a stepwise breakdown:

  1. Test License (Form MD13): Before applying for MD9, manufacturers must secure a Test License, which takes approximately 1.5 to 2 months.
  2. Product Testing: Samples must be tested at CDSCO-approved laboratories. Access the list of testing laboratories.
  3. Document Preparation: Prepare all requisite technical and quality documents.
  4. License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.
  5. Inspection and Audit: CDSCO inspectors will audit the manufacturing site and documents.
  6. Query Resolution: Address any queries or deficiencies raised during inspection.
  7. Grant of License (Form MD9): Upon satisfactory review, the license is granted.

For an in-depth guide, refer to our detailed MD9 License Guide.


Manufacturing License Documents Required

The documentation for the In Vitro Embryo Culture Medium (Class C) demands precision. Key documents include:

  • Company Constitution and Incorporation Certificates
  • Proof of Premises Ownership or Lease Agreement
  • Details of Technical Staff Qualifications and Experience
  • Fire NOC and Pollution Control Board NOC
  • Device Master File (DMF): Detailed device description, formulation, manufacturing process, quality control. See our Device Master File guide.
  • Plant Master File (PMF): Facility details, manufacturing environment, equipment, and personnel hygiene protocols. Refer to our Plant Master File guide.
  • Essential Principles Checklist: Compliance with CDSCO standards.
  • Risk Management File: Comprehensive assessment of device risks.
  • Test Reports: From CDSCO-approved laboratories.
  • Product Labels and Instructions for Use (IFU): Must comply with labeling regulations.
  • Quality Management System (QMS) Documents: Typically ISO 13485:2016 certification.

Careful preparation of these documents is crucial to avoid delays and rejections.


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

For companies importing this Class C device, the MD15 import license is mandatory. The process generally takes 5 to 6 months and involves:

  1. Document Compilation: Includes manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), DMF, PMF, Wholesale License, and Company Constitution.
  2. Application Submission: Submit Form MD14 through the CDSCO MD Online Portal.
  3. Departmental Review and Queries: Respond promptly to any queries.
  4. License Grant: Upon approval, the MD15 license is issued.

Government fees vary by risk class; for Class C devices, the fees are approximately 3000persiteand3000 per site and 1500 per product.

For more details, consult our Import License Guide.


Timeline and Processing Duration

StageDuration
Test License (MD13)1.5 to 2 months
Product Testing3 to 4 weeks
Document Preparation1 to 2 weeks
License Application Review1 to 2 months
Inspection and Audit2 to 4 weeks
Query ResolutionVariable (1-4 weeks)
Total for MD9 License4 to 5 months

For import licenses (MD15), expect 5 to 6 months due to extensive document verification.


Government Fees and Costs

Manufacturing License (MD9):

  • Application Fee: ₹50,000 per application
  • Product Fee: ₹1,000 per product

Test License (MD13):

  • Typically included within the overall application process fees

Import License (MD15):

  • Class C Devices: Approx. 3,000persiteand3,000 per site and 1,500 per product

Additional costs include testing fees at CDSCO-approved labs and audit fees charged by notified bodies.


Common Challenges and Solutions

Challenge 1: Delays in Test License and Product Testing

Challenge 2: Incomplete Documentation Leading to Queries

  • Solution: Use comprehensive checklists for DMF, PMF, risk files, and label compliance. Our Device Master File guide can streamline preparation.

Challenge 3: Audit Failures Due to Non-compliance

Challenge 4: High Costs and Budget Overruns

  • Solution: Plan budgets including all government fees, testing charges, and consultancy costs upfront.

Expert Consultation and Support

Navigating the CDSCO licensing process for a Class C device like the In Vitro Embryo Culture Medium requires specialized knowledge. Our seasoned consultants assist in:

  • Gap analysis of your current documentation
  • Preparation and review of DMF, PMF, and risk management files
  • Coordination with CDSCO-approved testing labs
  • Scheduling audits with notified bodies
  • Managing application submissions and query responses

Our success with over 500 companies attests to our commitment and expertise.


Getting Started with Your CDSCO License Application

To begin your journey towards CDSCO approval for your In Vitro Embryo Culture Medium, follow these practical steps:

  1. Assess Your Device Classification: Confirm Class C status using the Medical Device Classification tool.
  2. Initiate Test License Application: Prepare and submit Form MD13 on the CDSCO MD Online Portal.
  3. Engage a CDSCO-Approved Testing Laboratory: Schedule product testing immediately after receiving the test license.
  4. Compile Essential Documentation: Use expert guides to prepare DMF, PMF, risk management, and QMS files.
  5. Apply for MD9 License: Once testing is complete, file Form MD7 with all supporting documents.
  6. Prepare for Inspection: Conduct internal audits and resolve potential non-compliances.
  7. Respond Promptly to Queries: Expedite the licensing process by addressing CDSCO and auditor questions without delay.

Partnering with an experienced regulatory consultant can significantly reduce delays and elevate your chances of approval. Contact us today to initiate your CDSCO license application with confidence.

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About the Author

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Tails Azimuth
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