CDSCO License for Vitrification freezing kit
Medical Device Information
Intended Use
It is intended for use in Assisted Reproductive procedure for vitrification and storage of human oocytes (MII), Pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. It may include medicinal and protein supplements like Gentamicin, Dextran Serum Supplement (DSS), etc.
Comprehensive Guide to CDSCO Licensing for Vitrification Freezing Kit (Class C Medical Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized products like the Vitrification Freezing Kit, intended for use in assisted reproductive procedures. With over 25 years of experience and having supported 500+ companies in successful CDSCO licensing, we provide you with an expert, step-by-step guide tailored for this Class C obstetrical and gynecological device.
Understanding the Vitrification Freezing Kit and Its Regulatory Importance
The Vitrification Freezing Kit is designed to facilitate the vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes, cleavage stage embryos, and blastocyst stage embryos. Given its critical role in assisted reproductive technology, strict regulatory oversight ensures patient safety and product efficacy. The kit may also contain medicinal and protein supplements like Gentamicin and Dextran Serum Supplement (DSS), which underscores the need for thorough evaluation.
Regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing this device in India. The specific notification for this device is File No. 29/Misc./03/2020-DC (181), dated 03.06.2022, which classifies it under Class C.
CDSCO Regulatory Framework for Vitrification Freezing Kit
The CDSCO categorizes medical devices based on risk, intended use, and complexity. The Vitrification Freezing Kit falls under Class C (moderate to high risk), which means it requires licensing from the Central Licensing Authority.
The applicable manufacturing license is the MD9 license, and for importers, an MD15 import license is necessary. Both involve rigorous documentation, product testing, and inspections.
Risk Classification and License Requirements for Class C Devices
Class C devices are medium to high-risk devices requiring:
- Manufacturing License (MD9): Issued by CDSCO Central Licensing Authority
- Import License (MD15): For imported devices, also issued centrally
The MD9 license process involves product testing, audit by CDSCO inspectors, and compliance with quality management systems.
For detailed classification, visit our Medical Device Classification guide.
Manufacturing License Process for MD9 (Class C Device)
The MD9 license process is comprehensive and typically takes 4 to 5 months from start to finish:
- Obtain Test License (Form MD13): Required before product testing; processing time 1.5–2 months.
- Product Testing: Conducted at CDSCO-approved testing laboratories. The vitrification kit requires testing of all components, including supplements like Gentamicin and DSS, to ensure safety and performance.
- Prepare Documentation: Including Device Master File, Plant Master File, Risk Management File, and QMS documents.
- Submit Application (Form MD7): Apply via the CDSCO MD Online Portal.
- Inspection and Audit: CDSCO inspectors conduct a thorough audit of manufacturing premises and QMS compliance.
- Resolve Queries: Address any observations raised by CDSCO during inspection.
- Grant of License (Form MD9): Upon satisfactory completion of all steps.
Manufacturing License Documents Required
Preparing a robust dossier is critical. For the MD9 license, the following documents are mandatory:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement for Manufacturing Premises
- Details of Technical Staff and Their Qualifications
- Fire Safety and Pollution Control NOCs
- Device Master File (DMF): Detailed product specifications, manufacturing process, and controls (Device Master File Guide)
- Plant Master File (PMF): Description of manufacturing facilities and quality systems (Plant Master File Guide)
- Essential Principles Checklist
- Risk Management File compliant with ISO 14971 (Risk Management Guide)
- Product Test Reports from CDSCO-approved labs (Testing Laboratories List)
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documentation, preferably ISO 13485:2016 certification
Import License Process for MD15
For companies importing the Vitrification Freezing Kit, the MD15 license issued by CDSCO's Central Licensing Authority is mandatory. The process typically takes 5 to 6 months and includes:
- Document Preparation: Assemble manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
- Application Submission: File Form MD14 on the CDSCO MD Online Portal.
- Query Resolution: Address any queries raised by CDSCO.
- License Grant: Issuance of MD15 import license.
Import License Documents Required
Key documents for MD15 application include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Quality Management System Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License for distribution in India
- Company Constitution and Address Proof
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 2 months |
| Document Preparation | 2 - 3 weeks |
| License Application Review | 1 - 1.5 months |
| Inspection & Audit | 1 month |
| Query Resolution | 2 - 3 weeks |
| Total MD9 Process | 4 - 5 months |
| Total MD15 Process | 5 - 6 months |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee | Additional Notes |
|---|---|---|---|
| MD9 (Class C) | Rs 50,000 | Rs 1,000 | Central Licensing Authority |
| MD15 Import (Class C) | USD 3,000 | USD 1,500 | Fees payable in USD, Central Authority |
Please note fees are subject to change; always verify on the CDSCO MD Online Portal.
Common Challenges and Solutions
Challenge 1: Lengthy Product Testing
- Solution: Engage with CDSCO-approved labs early and ensure sample preparation meets all testing criteria. Our experience shows pre-audit internal testing reduces delays.
Challenge 2: Documentation Gaps
- Solution: Utilize detailed templates for DMF and PMF. Our Device Master File guide and Plant Master File guide can help streamline compilation.
Challenge 3: Audit Non-compliance
- Solution: Conduct pre-audit mock inspections and ensure QMS aligns with ISO 13485:2016 standards.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated regulatory affairs specialist to respond promptly and accurately.
Expert Consultation and Support
With over two decades of regulatory consultancy experience, we assist manufacturers and importers at every step—from dossier preparation to audit readiness and post-license compliance. Our tailored support accelerates approvals and minimizes rejections.
Getting Started with Your CDSCO License Application
- Assess your device classification and confirm required license type. For the Vitrification Freezing Kit, this is MD9 for manufacturing.
- Initiate the test license (MD13) application via the CDSCO MD Online Portal.
- Simultaneously prepare your Device Master File, Plant Master File, and Risk Management File.
- Engage accredited laboratories early for product testing.
- Plan for the CDSCO audit by reviewing all QMS and manufacturing processes.
- Submit your MD9 application (Form MD7) once test results and documentation are finalized.
We recommend partnering with an experienced regulatory consultant to navigate nuances and ensure a smooth journey. Reach out to us today to discuss your specific requirements for the Vitrification Freezing Kit and expedite your CDSCO licensing process.
