CDSCO License for In-Vitro Fertilization/  Embryo Transfer Catheter

Comprehensive Guide to CDSCO Licensing for In-Vitro Fertilization/Embryo Transfer Catheter (Class B Medical Device)

Entering the Indian medical device market with an In-Vitro Fertilization (IVF)/Embryo Transfer Catheter requires meticulous adherence to regulatory norms mandated by the Central Drugs Standard Control Organization (CDSCO). This catheter, intended for transferring cellular material into the uterus, is classified as a Class B medical device under the CDSCO framework, reflecting moderate risk due to its invasive use.

With over 25 years of experience assisting 500+ companies in obtaining CDSCO licenses, we provide you with a step-by-step, actionable roadmap to successfully secure your manufacturing or import license for this device.

CDSCO Regulatory Framework for IVF/Embryo Transfer Catheters

The CDSCO regulates all medical devices under the Medical Device Rules (MDR) 2017. Your catheter falls under the catheter category with a notified classification as Class B according to Notification No. 29/Misc/3/2017-DC (292) dated 06.06.2018. This classification determines the licensing authority and process:

• Class B devices require an MD5 manufacturing license granted by the State Licensing Authority.
• Imports require an MD15 import license issued by the Central Licensing Authority.

Understanding these frameworks ensures compliance and smooth entry into the Indian market.

Risk Classification and License Requirements for IVF Catheters

Your device’s Class B risk classification denotes moderate risk, necessitating a controlled licensing process:

For manufacturing, an MD5 license is mandatory and involves securing a test license (Form MD13) first. For imports, the MD15 license process applies without the test license requirement.

Manufacturing License Process for Class B Devices (MD5 License)

The MD5 licensing process is detailed and involves several critical steps:

1. Apply for Test License (Form MD13): This preliminary step enables product testing and takes approximately 1.5 to 2 months.
2. Product Testing: Your IVF catheter must be tested at CDSCO-approved laboratories. Choose from the list of notified testing laboratories for compliance testing.
3. Documentation Preparation: Prepare comprehensive technical documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. Submit Manufacturing License Application (Form MD3): File your application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body from the official list for auditing your manufacturing site.
6. Resolve Queries: Address any queries raised by CDSCO or the notified body promptly.
7. Grant of License (Form MD5): Upon successful audit and documentation review, the license is granted.

Manufacturing License Documents Required for IVF/Embryo Transfer Catheters

Ensure your application includes the following mandatory documents:

• Company Constitution Documents (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership/Lease of Manufacturing Premises
• Technical Staff Details with qualifications and experience
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing processes. Our Device Master File guide can help you structure this properly.
• Plant Master File (PMF) describing the manufacturing facility and quality controls. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File showing risk analysis, mitigation plans, and compliance with ISO 14971. See our risk management insights for detailed guidance.
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU) adhering to regulatory standards
• Quality Management System (QMS) Documents such as ISO 13485 certification and SOPs

Import License Process for IVF/Embryo Transfer Catheters (MD15 License)

For importers, the MD15 license is essential and is granted by the Central Licensing Authority. The process typically spans 5-6 months and includes:

1. Document Preparation: Compile all required documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, and technical files.
2. Application Filing: Submit Form MD14 via the CDSCO MD Online Portal.
3. Query Resolution: Promptly address any questions from the CDSCO.
4. License Grant (Form MD15)

Import License Documents Required

• Manufacturing License of Manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

| Import License (MD15) | 5 – 6 months |

Government Fees and Costs

For Class B devices like IVF catheters, the fee structure is as follows:

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
• MD13 Test License: Included in the process
• MD15 Import License: $2,000 per site +$1,000 per product

These fees exclude costs related to product testing, notified body audits, and document preparation.

Common Challenges and Solutions

Challenge 1: Delays in test license approval and product testing

• Solution: Initiate the test license application early and engage accredited labs promptly to avoid bottlenecks.

Challenge 2: Incomplete or inconsistent documentation

• Solution: Utilize standardized templates for Device and Plant Master Files. Our DMF and PMF guides provide detailed frameworks.

Challenge 3: Audit non-compliance

• Solution: Conduct internal audits and pre-audit assessments with notified bodies to ensure readiness.

Challenge 4: Slow query resolution

• Solution: Maintain a dedicated regulatory liaison to respond quickly and accurately to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing is complex, especially for specialized devices like IVF catheters. Our seasoned consultants have successfully guided over 500 companies through this process, reducing timelines and ensuring compliance. We offer:

• Customized gap analysis
• Document preparation assistance
• Coordination with notified bodies and testing laboratories
• Post-approval regulatory support

Getting Started with Your CDSCO License Application

1. Assess your device classification and confirm it as Class B per the official medical device classification guidelines.
2. Initiate your test license (MD13) application immediately via the CDSCO MD Online Portal.
3. Prepare comprehensive technical documentation including DMF, PMF, and Risk Management Files.
4. Engage with a notified body early to schedule your audit.
5. Plan your product testing with CDSCO-approved laboratories to avoid delays.
6. Submit your MD5 application (Form MD3) promptly upon receiving test license approval and test reports.
7. Maintain open communication with CDSCO authorities to swiftly resolve any raised queries.

By following these practical steps and leveraging expert guidance, you can confidently navigate the CDSCO licensing process for your In-Vitro Fertilization/Embryo Transfer Catheter and successfully enter the Indian market.

For detailed personalized assistance, feel free to reach out to our regulatory consulting team, leveraging 25+ years of proven expertise in CDSCO compliance.