CDSCO License for Foetal vacuum  extraction cup, reusable or single use

Comprehensive Guide to CDSCO Licensing for Foetal Vacuum Extraction Cup (Reusable or Single Use)

Foetal vacuum extraction cups are crucial obstetrical devices designed to assist in the delivery of a baby by applying gentle vacuum pressure to the fetal head. Given their direct application in critical medical procedures, regulatory compliance is paramount to ensure safety and efficacy. As a Class B medical device under the Indian CDSCO framework, obtaining the correct manufacturing or import license is essential for any manufacturer or importer aiming to access the Indian healthcare market.

With over 25 years of regulatory consultancy experience and having supported more than 500 companies in navigating CDSCO licensing, we provide practical, in-depth guidance tailored to your Foetal vacuum extraction cup product.

CDSCO Regulatory Framework for Foetal Vacuum Extraction Cups

The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. The foetal vacuum extraction cup falls under the Obstetrical and Gynecological category and is notified under File No. 29/Misc./03/2020-DC (181) dated 03.6.2022. This notification specifies the device’s classification as Class B, reflecting moderate risk.

As per the Medical Device Rules (MDR) 2017, manufacturers and importers must comply with specific licensing requirements, quality standards, and documentation to legally market this device in India.

Risk Classification and License Requirements for Foetal Vacuum Extraction Cups

Class B devices like the foetal vacuum extraction cup require an MD5 manufacturing license if produced domestically or an MD15 import license if brought into India.

• Class B (Moderate Risk): Requires MD5 license granted by the State Licensing Authority for manufacturing.
• Import: Requires MD15 license granted by the Central Licensing Authority.

Understanding this distinction is critical to initiating the correct application process and avoiding costly delays.

Manufacturing License Process (MD5) for Foetal Vacuum Extraction Cups

The MD5 license process involves multiple stages:

1. Test License Application (Form MD13): Initially, manufacturers must apply for a test license, which takes approximately 1.5 to 2 months.
2. Product Testing: Samples of the vacuum extraction cup must be tested in government-approved laboratories to verify compliance with Indian standards. Refer to the list of testing laboratories for accredited options.
3. Document Preparation: Comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and others must be compiled.
4. MD5 License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit by Notified Body: The manufacturing facility will undergo an audit by a notified body. Check the list of notified bodies to select an appropriate auditor.
6. Resolution of Queries: Address any queries raised by the department or notified body promptly.
7. Grant of MD5 License (Form MD5): Upon successful review, the license is granted.

The entire process typically requires 3 to 4 months, factoring in test licensing, testing, audit, and documentation.

Manufacturing License Documents Required for Foetal Vacuum Extraction Cups

Accurate documentation is vital for smooth processing. For the MD5 license, prepare the following:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing the design, materials, manufacturing process, and validations. Our Device Master File guide provides a step-by-step approach.
• Plant Master File (PMF) describing manufacturing infrastructure and quality systems. See our detailed Plant Master File guide.
• Essential Principles Checklist confirming compliance with MDR requirements
• Risk Management File outlining hazard analysis and mitigation strategies. Learn more on implementing risk management.
• Test Reports from government-approved labs
• Labels and Instructions For Use (IFU) conforming to Indian labeling norms
• Quality Management System (QMS) documents, typically ISO 13485:2016 certified

Import License Process (MD15) for Foetal Vacuum Extraction Cups

For importers, the MD15 license is mandatory. The process is as follows:

1. Documentation Preparation: Compile required documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, and others.
2. Application Submission: File Form MD14 through the CDSCO MD Online Portal.
3. Queries Resolution: Respond efficiently to any departmental queries.
4. License Grant: The MD15 license is issued typically within 5 to 6 months.

Import License Documents Required

Key documents for MD15 include:

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

Timeline and Processing Duration

Timely preparation of documents and early engagement with notified bodies or testing labs can significantly reduce processing times.

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD15 License:
  • Class B: USD 2,000 per site + USD 1,000 per product

Additional costs include testing fees, audit charges by notified bodies, and consultancy fees if external support is engaged.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with Essential Principles.

Solution: Engage experienced consultants early to conduct gap assessments. Maintain a checklist and use templates for DMF and PMF.

Challenge: Difficulty in coordinating product testing and audit scheduling.

Solution: Pre-schedule testing with accredited labs and notify auditors well in advance. Use the list of notified bodies and testing laboratories to identify reliable partners.

Challenge: Responding to technical queries from CDSCO officials.

Solution: Prepare detailed, clear responses with supporting documents. Having regulatory experts draft replies improves clarity and compliance.

Expert Consultation and Support

Navigating the CDSCO licensing process for foetal vacuum extraction cups can be complex. Our team has successfully guided over 500 clients through MD5 and MD15 licensing with tailored project management, document preparation, and compliance auditing.

We offer:

• Comprehensive regulatory strategy development
• Document drafting and review (DMF, PMF, Risk Management)
• Coordination with testing labs and notified bodies
• Query management and follow-up with CDSCO

Getting Started with Your CDSCO License Application

1. Conduct a Regulatory Gap Analysis: Assess your current documentation and quality systems against CDSCO MDR requirements.
2. Prepare Test License Application: For manufacturing, initiate the Form MD13 test license application via the CDSCO MD Online Portal.
3. Select Testing Laboratory: Choose an accredited lab from the approved testing laboratories list for product testing.
4. Compile Device and Plant Master Files: Utilize our Device Master File guide and Plant Master File guide to ensure completeness.
5. Schedule Audit with Notified Body: Identify suitable notified bodies for your audit requirements.
6. Submit Complete MD5 Application: Once testing and audit are complete, apply using Form MD3 on the CDSCO portal.

For importers, begin by collecting all necessary certificates and documentation, then apply for the MD15 license through the same portal.

By following these focused steps and leveraging expert support, manufacturers and importers of foetal vacuum extraction cups can achieve timely CDSCO licensing and successful market entry in India.