CDSCO License for Perineal orifice incontinence-control electrical stimulation system, remote control

Comprehensive Guide to CDSCO Licensing for Perineal Orifice Incontinence-Control Electrical Stimulation Systems (Class C Device)

As a regulatory consultancy with over 25 years of experience, having supported 500+ companies in successfully navigating CDSCO licensing, we understand the specific requirements and challenges involved in bringing innovative medical devices to the Indian market. This guide focuses on the Perineal orifice incontinence-control electrical stimulation system, remote control—a Class C, battery-powered urology device designed for intravaginal pelvic floor therapy.

Understanding the Device and Regulatory Importance

This device is a sophisticated assembly intended to treat urinary incontinence and related pelvic disorders in women via electrical stimulation. Given its invasive nature and therapeutic claims, it falls under Class C risk classification according to CDSCO guidelines. This classification mandates stringent regulatory scrutiny to ensure safety and efficacy, making compliance with CDSCO licensing a critical step for manufacturers and importers.

CDSCO Regulatory Framework for Class C Urology Devices

The Central Drugs Standard Control Organization (CDSCO) governs the approval process for medical devices in India. For Class C devices like the perineal electrical stimulation system, the MD9 license is required. The MD9 license is issued by the Central Licensing Authority and involves comprehensive testing, documentation, and audits to ensure adherence to Indian regulatory standards and international best practices.

Risk Classification and License Requirements

• Risk Class: C
• License Required: MD9 (Manufacturing License for Class C and D devices)
• Regulatory Authority: Central Licensing Authority (CDSCO HQ)
• Notification Reference: File No. 29/Misc./03/2020-DC (145) dated 23.8.2021

You can verify device classification and regulatory updates on the Medical Device Classification page.

Manufacturing License Process (MD9) for Class C Devices

The MD9 license process is multi-phased:

1. Test License Application (Form MD13): Before applying for MD9, obtain a Test License to facilitate product testing.
2. Product Testing: Conduct testing at CDSCO notified laboratories to validate safety and performance.
3. Documentation Preparation: Compile comprehensive technical and quality documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documentation.
4. License Application (Form MD7): Submit the manufacturing license application through the CDSCO MD Online Portal.
5. Audit and Inspection: CDSCO inspectors conduct audits to verify compliance.
6. Query Resolution: Address any queries raised during the audit.
7. License Grant: Upon successful review, the MD9 manufacturing license is issued.

For detailed guidance, refer to our MD9 License Guide.

Manufacturing License Documents Required for MD9

For your device, the following documents must be meticulously prepared and submitted:

• Company Constitution and Incorporation Certificates
• Proof of Premises Ownership or Lease Agreement
• Qualifications and Experience Details of Technical Staff
• Fire Safety NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device specifications, design, manufacturing process (Learn more about DMF)
• Plant Master File (PMF): Details of manufacturing facility and quality control (PMF Guide)
• Essential Principles Checklist confirming compliance with Indian Medical Device Rules
• Risk Management File documenting hazard analysis and mitigation (Risk Management Insights)
• Test Reports from CDSCO approved laboratories (Testing Labs List)
• Product Labels, Instructions for Use (IFU), and Packaging Details
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification

Import License Process (MD15) for Perineal Electrical Stimulation Devices

If you are an importer intending to bring this device into India, the MD15 import license is mandatory. The process involves:

• Preparation of import-specific documents including manufacturing license, Free Sale Certificate, ISO certification, and CE certificates.
• Application submission on the CDSCO MD Online Portal.
• Addressing queries from CDSCO during the review.
• License issuance typically within 5-6 months.

Refer to our detailed Import License Guide for step-by-step assistance.

Timeline and Processing Duration

• Test License (MD13): Approximately 1.5 to 2 months.
• Product Testing: 4 to 6 weeks depending on laboratory workload.
• MD9 License Application and Audit: 2 to 3 months.

Total estimated duration: 4 to 5 months from test license application to manufacturing license grant.

Government Fees and Costs

• Test License (MD13): Fees vary, typically Rs 5,000.
• MD9 License Application: Rs 50,000 per application plus Rs 1,000 per product.
• Product Testing: Charges depend on the number and type of tests; anticipate Rs 50,000 to Rs 1,00,000.
• Audit and Consultancy: Costs vary depending on notified body and consultant fees.

Accurate budgeting is crucial to avoid delays. For audit services, consult the List of Notified Bodies.

Common Challenges and Solutions

Challenge 1: Documentation Gaps Many manufacturers struggle with preparing comprehensive DMF and PMF files.

Solution: Engage expert consultants early to develop compliant master files using templates and checklists.

Challenge 2: Delays in Product Testing Testing labs often have backlogs, extending timelines.

Solution: Schedule testing in advance and use CDSCO-approved labs with faster turnaround times.

Challenge 3: Audit Non-Compliance Failure to meet audit criteria due to incomplete QMS or facility issues.

Solution: Conduct internal pre-audits and remediate gaps before official CDSCO inspections.

Challenge 4: Query Resolution Delays Prolonged response times to CDSCO queries can stall license grants.

Solution: Prepare a dedicated regulatory team to respond promptly with detailed evidence.

Expert Consultation and Support

Leveraging over two decades of regulatory expertise, we provide end-to-end support—from initial classification and document preparation to audit facilitation and license submission. Our clients benefit from:

• Customized regulatory strategy for Class C urology devices
• Preparation of DMF, PMF, and Risk Management files
• Coordination with testing laboratories and notified bodies
• Timely query resolution and application tracking

Contact us early to streamline your CDSCO licensing journey.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device as Class C using official guidelines.
2. Prepare Test License Application (MD13): Gather initial documents and submit via the CDSCO MD Online Portal.
3. Identify Testing Laboratory: Select an approved lab from the CDSCO Testing Laboratories list.
4. Develop Comprehensive Documentation: Engage experts to prepare DMF, PMF, Risk Management, and QMS documents.
5. Schedule Audits: Coordinate with notified bodies for your facility audit.
6. Submit MD9 Application (Form MD7): Once test license and test reports are ready, apply online.
7. Manage Queries Efficiently: Assign a regulatory lead to respond swiftly to CDSCO queries.

Starting with a detailed project plan and experienced guidance dramatically improves your chances of a smooth approval process. Our team is ready to assist you through every step to ensure your perineal orifice incontinence-control electrical stimulation system gains timely CDSCO approval for successful market entry in India.