CDSCO License for Intra-vaginal organ positioning device for diagnostic imaging and radiotherapy

Introduction: Understanding the Intra-Vaginal Organ Positioning Device and Regulatory Importance

The intra-vaginal organ positioning device is a critical medical device designed to facilitate accurate positioning of organs such as the uterine cervix, rectum, and urinary bladder during diagnostic imaging and radiotherapy. By ensuring reproducible placement, it enhances the precision and effectiveness of continuous image examinations and radiotherapy treatments. Given its direct application in sensitive anatomical areas and role in radiotherapy, this device is classified as a Class B medical device under Indian regulations, necessitating specific regulatory compliance to guarantee patient safety and efficacy.

Navigating the Central Drugs Standard Control Organization (CDSCO) regulatory framework is essential for any manufacturer or importer aiming to market this device in India. Our 25+ years of expertise in CDSCO licensing have enabled over 500 companies to successfully obtain licenses for similar devices, ensuring a smooth pathway through complex regulatory requirements.

CDSCO Regulatory Framework for Intra-Vaginal Organ Positioning Devices

Medical devices in India are regulated under the Medical Device Rules (MDR) 2017, enforced by CDSCO. The intra-vaginal organ positioning device falls under the radiotherapy category and is notified under File No. 29/Misc./03/2020-DC (180) dated 6.8.2021. Being a Class B device, it is subject to moderate regulatory controls aimed at safeguarding patient health while facilitating device availability.

The license for manufacturing this device is governed by the MD5 licensing process, which is managed by the State Licensing Authority. Importers must obtain an MD15 import license from the Central Licensing Authority, subject to separate but related documentation and fees.

Risk Classification and License Requirements for Class B Devices

Class B devices pose moderate risk and thus require:

• An MD5 Manufacturing License (Form MD3 application) from the State Authority
• A Test License (Form MD13) prior to the manufacturing license
• Compliance with Good Manufacturing Practices (GMP) and quality management systems
• Product testing in government-approved laboratories
• An audit by a notified body

For a comprehensive understanding of device classification, manufacturers can refer to our detailed Medical Device Classification guide.

Manufacturing License Process (MD5) for Intra-Vaginal Organ Positioning Device

The MD5 license process for Class B devices is methodical and typically spans 3 to 4 months, involving several critical steps:

1. Test License Application (Form MD13): Initiate by applying for a test license on the CDSCO MD Online Portal. This license allows you to manufacture limited quantities for testing purposes.

2. Product Testing: Conduct testing at CDSCO-approved laboratories to verify compliance with performance and safety standards. Access the list of Testing Laboratories to select an appropriate facility.

3. Document Preparation: Prepare comprehensive documentation, including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.

4. Application Submission: File the MD5 license application (Form MD3) on the CDSCO MD Online Portal.

5. Audit by Notified Body: The notified body conducts an onsite audit of your manufacturing premises and quality systems. Refer to the list of notified bodies authorized for MD5 audits.

6. Resolution of Queries: Address any observations or queries raised by the CDSCO or notified body promptly.

7. Grant of License: Upon satisfactory compliance, CDSCO issues the MD5 manufacturing license (Form MD5).

Detailed guidance on the MD5 license process can be found in our MD5 License Guide.

Manufacturing License Documents Required

For the intra-vaginal organ positioning device, the following documents are essential:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (comprehensive device specifications and design data)
• Plant Master File (manufacturing processes and infrastructure) – learn how to create one in our Plant Master File Guide
• Essential Principles Checklist confirming compliance with applicable standards
• Risk Management File demonstrating hazard analysis and mitigation strategies
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification recommended)

Preparation of these documents requires meticulous attention to detail to avoid common delays or rejections.

Import License Process (MD15) for Intra-Vaginal Organ Positioning Device

For companies intending to import this device into India, the MD15 license from the Central Licensing Authority is mandatory. The process typically takes 5 to 6 months and involves:

1. Document Preparation: Collate all required documents including the 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.

2. Application Submission: File the MD15 license application (Form MD14) via the CDSCO MD Online Portal.

3. Queries and Clarifications: Respond to any department queries thoroughly.

4. License Grant: Upon successful review, CDSCO issues the MD15 import license.

For a detailed breakdown, please consult our Import License Guide.

Import License Documents Required

Key documents for the MD15 license include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate indicating the device is legally sold in the country of origin
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale Drug License for distribution in India
• Company Constitution documents

Ensuring all documents are current and correctly notarized can significantly expedite processing.

Timeline and Processing Duration

Manufacturers should anticipate some overlap between testing and document preparation to optimize overall timelines.

Government Fees and Costs

For the intra-vaginal organ positioning device (Class B), the fee structure is as follows:

• MD5 Manufacturing License:

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

• MD15 Import License:

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

Additional costs include fees for testing at CDSCO-approved laboratories, audit fees charged by notified bodies, and consultancy charges if opting for expert assistance.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with CDSCO-approved testing labs early. Maintain clear communication to understand test timelines and prepare samples accurately.

Challenge 2: Incomplete Documentation

• Solution: Use standardized templates and checklists. Our Device Master File guide and Plant Master File guide can help streamline documentation.

Challenge 3: Audit Non-compliance

• Solution: Conduct internal audits to ensure GMP and QMS compliance before notified body inspections.

Challenge 4: Query Resolution Delays

• Solution: Assign dedicated regulatory personnel to respond promptly and comprehensively to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing for specialized devices like intra-vaginal organ positioning devices requires a deep understanding of regulatory nuances. Our seasoned regulatory consultants have helped over 500 companies successfully obtain MD5, MD9, and MD15 licenses. We offer end-to-end support—from documentation, application filing, audit preparation, to query handling—ensuring your compliance journey is seamless.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device’s Class B status under the MDR.

2. Prepare Preliminary Documentation: Assemble company and technical documents, and initiate the Device and Plant Master Files.

3. Apply for Test License: Submit Form MD13 for the test license via the CDSCO MD Online Portal.

4. Plan Product Testing: Coordinate with CDSCO-approved labs early to schedule testing.

5. Develop QMS and Risk Management Files: Implement ISO 13485:2016 standards and risk management practices as per the Risk Management guide.

6. Engage a Notified Body: Identify and contract a notified body from the list of notified bodies for your audit.

7. Submit MD5 Application: Once testing and document preparation are complete, file Form MD3 on the CDSCO portal.

Embarking on this process with expert guidance significantly lowers the risk of delays or rejections. Contact us today to leverage our proven expertise and ensure your intra-vaginal organ positioning device complies with all CDSCO requirements efficiently.