CDSCO License for Foetal vacuum extraction system monitor

Introduction to Foetal Vacuum Extraction System Monitor and Regulatory Importance

Foetal vacuum extraction system monitors play a crucial role in obstetrical care by measuring and recording vacuum parameters during assisted deliveries. This battery-powered device, connected to the suction line of a foetal vacuum cup, ensures safe and effective vacuum application by tracking vacuum levels, pull counts, durations, and pop-offs. Given its direct impact on maternal and neonatal safety, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is mandatory before market entry in India.

Navigating CDSCO licensing for a Class B device such as this requires clear understanding of the regulatory framework, documentation, timelines, and costs. With over 25 years of experience supporting 500+ companies in India, we provide comprehensive insights to streamline your licensing journey.

CDSCO Regulatory Framework for Foetal Vacuum Extraction System Monitor

The CDSCO regulates all medical devices under the Medical Device Rules (MDR), 2017, which classify devices based on risk. For the foetal vacuum extraction system monitor, classified as Class B (low-moderate risk), the regulatory pathway involves obtaining a manufacturing license under the MD5 category or an import license under MD15 if sourcing from outside India.

Manufacturers of Class B devices must comply with essential principles of safety and performance, maintain quality management systems, and ensure product testing by CDSCO-approved labs prior to licensing and sale.

Risk Classification and License Requirements

The foetal vacuum extraction system monitor is categorized under obstetrical and gynecological devices and falls under Class B risk classification. This classification mandates the following:

• Manufacturing License: MD5 License (Application Form MD3) granted by State Licensing Authority
• Test License: MD13 (Test License) application prior to product testing
• Product Testing: Conducted at CDSCO approved notified laboratories

For detailed risk classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD5 License)

The manufacturing license process for a Class B device such as this involves multiple sequential steps:

1. Apply for Test License (Form MD13): This initial license allows testing of your device samples in government-approved labs.
2. Product Testing: Send device samples to CDSCO-approved labs to obtain test reports confirming compliance.
3. Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, QMS documents, and others.
4. Apply for Manufacturing License (Form MD3): Submit the complete application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo an audit by a notified body listed here to verify compliance.
6. Respond to Queries: Address any clarifications or additional information requests from CDSCO or the notified body.
7. License Grant (Form MD5): Upon satisfactory compliance, the State Licensing Authority grants the manufacturing license.

For a step-by-step walkthrough, our detailed MD5 License Guide is highly recommended.

Manufacturing License Documents Required

Your application must include the following key documents:

• Company Constitution and Registration Proof
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification Certificates
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design, specifications, and performance
• Plant Master File (PMF) describing manufacturing processes and quality controls
• Essential Principles Checklist demonstrating compliance with MDR
• Risk Management File in line with ISO 14971 principles
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation (preferably ISO 13485:2016 certified)

We suggest reviewing our comprehensive guides on Device Master File and Plant Master File for detailed preparation.

Import License Process (MD15 License)

If you plan to import the foetal vacuum extraction system monitor, the import license (MD15) is issued by the Central Licensing Authority. The process includes:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, wholesale license, and company constitution.
• Submission of application via the CDSCO MD Online Portal.
• Clarifications and queries resolution.
• Grant of import license (Form MD15).

Note that unlike manufacturing, no test license is required prior to application for import. The timeline is approximately 5-6 months.

For a deeper dive, see our Import License Guide.

Import License Documents Required

Key documents for import license include:

• Valid Manufacturing License from the manufacturer’s country
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and relevant registrations

Ensure all documents are translated into English and notarized where required to avoid delays.

Timeline and Processing Duration

For Manufacturing License (MD5):

• Test License (MD13): 1.5-2 months
• Product Testing: 1-1.5 months (depending on lab workload)
• Document Preparation and Submission: 2-3 weeks
• Audit and Queries Resolution: 1-1.5 months
• Total Duration: Approximately 3-4 months

For Import License (MD15):

• Document Preparation and Submission: 1 month
• Queries Resolution: 3-4 months
• Total Duration: Approximately 5-6 months

Planning ahead and ensuring complete documentation upfront can reduce processing times significantly.

Government Fees and Costs

MD5 Manufacturing License Fees:

• Application Fee: INR 5,000
• Per Product Fee: INR 500

MD15 Import License Fees (approximate USD equivalent):

• Class B Device: USD 2,000 per site + USD 1,000 per product

Additional costs to budget for include product testing fees from notified laboratories and notified body audit charges.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or inconsistent documents. Using detailed checklists and expert review before submission helps.
• Test Lab Delays: Government-approved labs can have backlogs. Selecting labs with shorter turnaround times and early sample submission can mitigate delays.
• Audit Non-Compliance: Ensure QMS and manufacturing processes strictly adhere to MDR and ISO 13485 to pass audits.
• Query Management: Timely and precise responses to CDSCO queries avoid prolonged processing.

Our experience shows proactive planning and professional consultation dramatically improve approval success rates.

Expert Consultation and Support

With 25+ years of regulatory expertise and over 500 successful CDSCO license procurements, our team provides end-to-end support including:

• Gap analysis and documentation preparation
• Device and Plant Master File compilation
• Coordination with notified bodies and testing labs
• Application filing and query resolution

Engage us early in your licensing process to benefit from our deep domain knowledge and practical insights.

Getting Started with Your CDSCO License Application

To initiate your CDSCO journey for the foetal vacuum extraction system monitor:

1. Register your company on the CDSCO MD Online Portal.
2. Identify the appropriate State Licensing Authority for your manufacturing site.
3. Begin compiling required documents, focusing on Device and Plant Master Files, Risk Management, and QMS.
4. Apply for the Test License (Form MD13) to start product testing.
5. Concurrently, prepare for notified body audit by reviewing compliance with MDR and ISO 13485.

Starting early and maintaining close communication with regulatory authorities ensures a smooth licensing process and timely market access.

For personalized assistance or to discuss your specific project, contact our expert regulatory consultants today.