CDSCO License for Foetal vacuum extraction system,  manual, reusable or single use

Comprehensive CDSCO Licensing for Foetal Vacuum Extraction Systems (Class B)

Navigating the regulatory landscape for medical devices in India can be complex, especially for critical obstetrical devices like the Foetal Vacuum Extraction System. This manual, reusable or single-use device plays an essential role in facilitating safe delivery during vaginal childbirth or Caesarean sections. Given its classification as a Class B medical device under CDSCO regulations, manufacturers and importers must ensure strict compliance to access the Indian market seamlessly.

With over 25 years of experience guiding 500+ companies through CDSCO licensing, we provide you with a detailed roadmap tailored for this device category. Our insights cover every step—from understanding regulatory frameworks to practical tips on documentation, timelines, and cost management.

CDSCO Regulatory Framework for Foetal Vacuum Extraction Systems

The Central Drugs Standard Control Organization (CDSCO) is India’s apex regulatory body for medical devices. Since the notification dated 03.06.2022 (File No. 29/Misc./03/2020-DC (181)), the Foetal Vacuum Extraction System is regulated under the Obstetrical and Gynecological device category with a Class B risk classification.

These devices require a manufacturing license under the MD5 category, issued by the State Licensing Authority, aligning with Indian Medical Device Rules (IMDR) 2017 and subsequent amendments.

Understanding these frameworks is critical, as improper licensing can lead to regulatory delays or market access denial.

Risk Classification and License Requirements for Class B Devices

Class B devices are considered low to moderate risk. For Foetal Vacuum Extraction Systems, this classification mandates the following:

• Manufacturing License (MD5): Required for Indian manufacturers.
• Test License (MD13): A prerequisite for product testing before the main license application.
• Import License (MD15): For imported devices, granted by the Central Licensing Authority.

The MD5 license application involves rigorous documentation, product testing, and audit by notified bodies. This ensures device safety and compliance with essential principles.

For more details on medical device classification, visit our Medical Device Classification guide.

Manufacturing License Process (MD5) for Foetal Vacuum Extraction Systems

The manufacturing license process for Class B devices like the Foetal Vacuum Extraction System involves several critical stages:

1. Test License Application (Form MD13): Apply via the CDSCO MD Online Portal to obtain a test license, which typically takes 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at government-approved laboratories listed here. Testing ensures compliance with Indian safety and performance standards.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. License Application Submission (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo an on-site audit by a notified body from the official Notified Bodies List.
6. Queries and Clarifications: Respond promptly to any queries raised during the audit or by CDSCO.
7. Grant of MD5 License (Form MD5): Upon successful audit and document verification, receive your manufacturing license.

Manufacturing License Documents Required

To streamline your application, ensure you have the following documents ready:

• Company Constitution (MOA/AOA)
• Proof of ownership/lease of manufacturing premises
• Qualification certificates and experience proof of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing design, specifications, and manufacturing process (see our Device Master File guide)
• Plant Master File outlining facility details (Plant Master File guide)
• Essential Principles Checklist confirming compliance
• Risk Management File highlighting hazard analysis and mitigation (Risk Management insights)
• Test Reports from accredited labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 preferred)

Import License Process (MD15) for Foetal Vacuum Extraction Systems

For importers of Foetal Vacuum Extraction Systems, the MD15 license is mandatory. The process includes:

1. Document Preparation: Collect necessary documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, Wholesale license, and Company Constitution.
2. Application Filing: Submit Form MD14 via the CDSCO MD Online Portal.
3. Queries Resolution: Address any queries raised by the CDSCO.
4. License Grant: Receive the MD15 import license.

Import License Documents Required

Documents required for MD15 application include:

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution

Timeline and Processing Duration

Timely submission of complete documentation and proactive handling of queries significantly reduce delays.

Government Fees and Costs

For the Foetal Vacuum Extraction System (Class B), the following fees apply:

• MD5 License:

  • Application fee: Rs 5,000
  • Per product fee: Rs 500

• Test License (MD13): Included in the above process

• MD15 License (Import):

  • Site Fee: $2,000 USD
  • Per product Fee: $1,000 USD

Note that notified body audit fees and testing laboratory charges are separate and vary depending on the provider.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or unclear device classification.

Solution: Engage experts to verify classification and prepare a comprehensive dossier upfront.

Challenge: Difficulty in scheduling audits with notified bodies.

Solution: Early coordination with notified bodies listed on the CDSCO portal ensures timely audits.

Challenge: Testing failures causing re-submissions.

Solution: Pre-assessment of product quality and pre-testing can mitigate risks.

Expert Consultation and Support

With decades of regulatory experience, we assist clients by:

• Clarifying classification and regulatory routes
• Preparing Device and Plant Master Files
• Coordinating with notified bodies and testing labs
• Managing online applications via the CDSCO MD Online Portal
• Ensuring compliance with essential principles and risk management

Our tailored approach has helped over 500 companies successfully obtain CDSCO licenses for obstetrical devices like the Foetal Vacuum Extraction System.

Getting Started with Your CDSCO License Application

1. Evaluate Device Classification: Confirm your device is Class B as per the notification dated 03.06.2022.
2. Prepare Documentation: Begin compiling necessary documents with a focus on Device and Plant Master Files, risk management, and QMS.
3. Apply for Test License (MD13): Submit your application early via the CDSCO MD Online Portal.
4. Coordinate Testing: Schedule testing at CDSCO-approved laboratories promptly.
5. Engage a Notified Body: Contact notified bodies from the official list for pre-audit guidance.
6. Submit Manufacturing License Application (MD5): Upload all documents and audit reports to the portal.
7. Resolve Queries Quickly: Assign a dedicated regulatory expert to handle CDSCO or notified body queries.

By following these actionable steps and leveraging expert support, your Foetal Vacuum Extraction System can achieve timely CDSCO approval, making your entry into the Indian market smooth and compliant.

For detailed licensing guidance, explore our dedicated MD5 License Guide.

Partner with us to leverage 25+ years of regulatory expertise and ensure your Foetal Vacuum Extraction System meets all CDSCO requirements efficiently and successfully.