CDSCO License for Fallopian tube occlusion insert

Introduction to Fallopian Tube Occlusion Insert and Regulatory Importance

The Fallopian Tube Occlusion Insert is a high-risk Class D obstetrical and gynecological medical device designed as a contraceptive implant by obstructing the natural fallopian tube passage. Given its critical role in reproductive health and permanent implantation, stringent regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures its safety and effectiveness before market entry in India.

Navigating the CDSCO licensing framework for such a Class D device demands thorough preparation, compliance with technical standards, and detailed documentation. With over 25 years of experience assisting 500+ manufacturers and importers in securing CDSCO licenses, we provide expert guidance tailored to this device category.

CDSCO Regulatory Framework for Fallopian Tube Occlusion Insert

Being classified as a Class D device, the Fallopian Tube Occlusion Insert falls under the highest risk category per CDSCO’s medical device regulations. This classification mandates centralized approval through the CDSCO’s Central Licensing Authority, requiring a comprehensive MD9 manufacturing license for domestic production or MD15 import license for foreign manufacturers.

The regulatory framework emphasizes compliance with Indian Medical Device Rules, 2017 and adherence to essential principles related to safety, performance, and quality. The device must undergo rigorous testing, technical documentation assessment, and facility audits before license issuance.

Risk Classification and License Requirements

• Device Risk Class: D (Highest Risk)
• Applicable License: MD9 Manufacturing License (for Indian manufacturers)
• Authority: Central Licensing Authority (CDSCO Headquarters)
• Applicable Forms:
  • Test License: Form MD13
  • Manufacturing License: Form MD7 (application), Form MD9 (license grant)

This classification means manufacturers must complete a detailed evaluation process including product testing in government-approved laboratories, quality management audits, and compliance with stringent documentation requirements.

Manufacturing License Process (MD9)

For manufacturing the Fallopian Tube Occlusion Insert in India, the MD9 license is mandatory. The process involves several sequential steps:

1. Test License Application (Form MD13): Obtain permission to conduct product testing. This stage typically takes 1.5 to 2 months.
2. Product Testing: Submit samples to CDSCO-recognized testing laboratories. Testing duration varies but usually lasts 1 to 1.5 months.
3. Documentation Preparation: Compile all required technical and quality documents, including Device Master File and Plant Master File.
4. License Application Submission (Form MD7): Apply for the manufacturing license through the CDSCO MD Online Portal.
5. Inspection and Audit: CDSCO officials conduct facility audits and review documentation.
6. Query Resolution: Address any observations or queries raised during inspection.
7. License Grant (Form MD9): Upon satisfactory compliance, the manufacturing license is issued.

The total timeline for obtaining the MD9 license is approximately 4 to 5 months from initial test license application.

Manufacturing License Documents Required

For the MD9 license application for the Fallopian Tube Occlusion Insert, manufacturers must prepare the following documents meticulously:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed description of device design, components, manufacturing process, and quality controls. Refer to our comprehensive Device Master File guide.
• Plant Master File (PMF): Details of manufacturing facility, equipment, quality systems. See our Plant Master File guide.
• Essential Principles Checklist demonstrating compliance with Indian Medical Device Rules
• Risk Management File documenting hazard analysis and mitigation strategies. Learn more about implementing medical device risk management.
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably aligned with ISO 13485:2016

Ensuring completeness and accuracy of these documents significantly reduces delays during the audit phase.

Import License Process (MD15)

For foreign manufacturers or importers of the Fallopian Tube Occlusion Insert, the CDSCO MD15 import license is compulsory before marketing the device in India. The import license process includes:

1. Document Preparation: Submission of manufacturing license from the country of origin, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, Free Sale Certificate, Wholesale License, and Company Constitution.
2. Application Submission: File Form MD14 through the CDSCO MD Online Portal for the import license.
3. Query Resolution: Address any CDSCO queries promptly.
4. License Grant: Upon satisfactory review, the MD15 import license is issued.

Import license processing typically spans 5 to 6 months. Unlike manufacturing licenses, a test license is not required but comprehensive technical documentation must be submitted.

Import License Documents Required

Key documents include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate (FSC) or Certificate to Market
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File (DMF)
• Plant Master File (PMF)
• Wholesale License for India-based importers
• Company Constitution and incorporation certificates

The import license fees vary based on device class and number of products imported.

Timeline and Processing Duration

For the Fallopian Tube Occlusion Insert (Class D), expect around 4 to 5 months for MD9 manufacturing license and 5 to 6 months for MD15 import license from application submission to license grant.

Government Fees and Costs

MD9 License Fees (Manufacturing)

• Application Fee: Rs 50,000 per application
• Product Fee: Rs 1,000 per product

MD15 License Fees (Import)

• Class C & D Devices:
  • Rs 3,00,000 per site
  • Rs 1,50,000 per product

Additional costs include testing charges at government-approved labs and fees for audits by notified bodies or CDSCO inspectors.

Common Challenges and Solutions

1. Delayed Test Reports: Testing in government-approved labs can face backlogs. We recommend early scheduling and submission to approved labs listed on the CDSCO Testing Laboratories page.
2. Incomplete Documentation: Missing or inconsistent Device Master Files and Risk Management Files often lead to audit queries. Utilize our detailed Device Master File guide and risk management resources.
3. Audit Non-Compliance: Facility audits may reveal gaps in QMS or technical staff qualifications. Conduct internal audits and staff training well ahead of CDSCO inspections.
4. Query Resolution Delays: Prompt and clear responses to CDSCO queries can avoid prolonged processing times.

Expert Consultation and Support

Our team has successfully guided over 500 companies through the CDSCO licensing maze for high-risk devices like the Fallopian Tube Occlusion Insert. We offer:

• End-to-end application preparation
• Device and Plant Master File development
• Risk management implementation
• Coordination for product testing and audits
• Real-time query handling with CDSCO

Partnering with experienced consultants reduces risks of rejection and accelerates market access.

Getting Started with Your CDSCO License Application

To initiate your MD9 manufacturing license for the Fallopian Tube Occlusion Insert:

1. Register on the CDSCO MD Online Portal: Begin by creating your company profile.
2. Apply for Test License (Form MD13): Obtain clearance to conduct mandatory product testing.
3. Engage Accredited Testing Laboratories: Schedule tests early to avoid delays.
4. Prepare Comprehensive Documentation: Assemble all technical files, QMS documents, and statutory certificates.
5. Plan for Audit: Ensure your manufacturing site complies with CDSCO requirements.
6. Submit Manufacturing License Application (Form MD7): Track application status and promptly address any queries.

By following these practical steps with expert support, you can confidently navigate the regulatory pathway for this critical Class D contraceptive device and successfully enter the Indian market.