CDSCO License for Urinary-incontinence vaginal insert, reusable

Comprehensive Guide to CDSCO Licensing for Urinary-Incontinence Vaginal Inserts (Reusable, Class A Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for innovative products like the reusable urinary-incontinence vaginal insert. This device, classified as Class A under CDSCO regulations, plays a crucial role in providing non-invasive relief to adult females experiencing mixed or stress urinary incontinence by offering urethral support during abdominal pressure events such as coughing or sneezing. Given its vital function and patient safety considerations, securing the appropriate CDSCO license is mandatory before manufacturing or marketing in India.

With over 25 years of experience and having assisted 500+ companies in achieving regulatory compliance, we present an expert roadmap to successfully obtain the CDSCO manufacturing license (MD5) tailored specifically for this Class A urology device.

CDSCO Regulatory Framework for Medical Devices: Urinary-Incontinence Vaginal Inserts

The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. As per the medical device notification dated 23.08.2021 (File No. 29/Misc./03/2020-DC (145)), urinary-incontinence vaginal inserts fall under the Class A risk category, indicating a low-risk device.

All Class A devices require a manufacturing license granted by the State Licensing Authority, and the regulatory pathway involves obtaining a test license, performing product testing, and undergoing an audit before the final manufacturing license (MD5) is issued.

For detailed device classification, visit our Medical Device Classification guide.

Risk Classification and License Requirements for Class A Devices

Class A devices like the reusable urinary-incontinence vaginal insert are considered low risk. The regulatory requirements include:

• Test License (Form MD13): Initial authorization to manufacture for testing purposes.
• Product Testing: Conducted at CDSCO-approved government laboratories.
• Manufacturing License (Form MD3): Final license known as MD5, issued after audit and document verification.

The entire process typically spans 3 to 4 months.

Manufacturing License Process (MD5) for Urinary-Incontinence Vaginal Inserts

1. Apply for Test License (MD13): Submit the application through the CDSCO MD Online Portal to obtain permission to manufacture samples for testing.
2. Product Testing: Send samples to one of the CDSCO-approved testing laboratories for compliance verification.
3. Document Preparation: Prepare comprehensive technical documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
4. Apply for Manufacturing License (MD5) Using Form MD3: Submit the application along with all required documents.
5. Audit by Notified Body: Engage a notified body from the official list for the mandatory audit of manufacturing premises and processes.
6. Resolve Queries: Address any observations or queries raised by the licensing authority or notified body.
7. Grant of License: Upon satisfactory compliance, the State Licensing Authority issues the MD5 license.

We recommend closely tracking each step to avoid delays.

Manufacturing License Documents Required for MD5 Application

To streamline your application for this Class A device, prepare the following:

• Company Constitution (e.g., Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification & Experience Certificates of Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF): Detailed design and manufacturing process documents (read our DMF guide)
• Plant Master File (PMF): Information on manufacturing facilities (see PMF guide)
• Essential Principles Checklist
• Risk Management File (learn more about risk management)
• Product Test Reports from government-approved labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485 compliant recommended)

Completing this checklist thoroughly reduces the risk of application rejection or delay.

Import License Process (MD15) Overview

For importers of the urinary-incontinence vaginal insert, the MD15 license issued by the Central Licensing Authority is required. This process differs from manufacturing licenses by:

• Not requiring a test license
• Necessitating additional documents like Free Sale Certificate, ISO 13485:2016 certification, CE Certificate
• Longer processing time (~5-6 months)

Given the device’s Class A status, import license fees and documentation are comparatively lower but still require meticulous preparation. For detailed import license guidance, explore our Import License Guide.

Timeline and Processing Duration for MD5 License

Total Estimated Time: Approximately 3 to 4 months from start to finish.

Government Fees and Costs for Class A Device Licensing

• Test License (MD13): No separate fee; included in overall process.
• Manufacturing License (MD5):
  • Application Fee: Rs 5,000
  • Per Product Fee: Rs 500

Additional Costs to Consider:

• Product testing fees at government-approved labs (varies by tests required)
• Fees for audits conducted by a notified body
• Costs for document preparation and consultancy (if outsourced)

Budgeting realistically upfront helps prevent surprises.

Common Challenges and Practical Solutions

• Delay in Product Testing: Samples must be sent promptly to certified labs. Engage labs early and track testing progress.
• Incomplete Documentation: Use checklists and templates for Device Master and Plant Master Files to ensure completeness.
• Audit Non-Compliance: Conduct internal pre-audit inspections to identify gaps before the official audit.
• Query Resolution Delays: Respond to regulatory queries comprehensively and promptly to avoid processing halts.

Our hands-on approach has helped clients overcome these hurdles efficiently.

Expert Consultation and Support

With 25+ years of regulatory expertise, we specialize in:

• End-to-end CDSCO license application management
• Preparation of technical and quality documentation
• Coordination with notified bodies and testing labs
• Pre-audit readiness and compliance training

Our proven track record ensures a smooth pathway to market entry.

Getting Started with Your CDSCO License Application for Urinary-Incontinence Vaginal Inserts

1. Register on the CDSCO MD Online Portal immediately to access application forms.
2. Initiate your Test License (MD13) application to begin the process.
3. Engage a notified body early for audit scheduling.
4. Prepare your documentation using our recommended templates and guides.
5. Plan sample testing with government-approved labs to align with timelines.
6. Maintain constant communication with regulatory authorities to track application status.

Embarking on the licensing journey with a clear roadmap and expert support dramatically increases your chances of timely approval and successful market entry.

For comprehensive assistance, contact our regulatory consultancy team to tailor a strategy specific to your urinary-incontinence vaginal insert manufacturing or import project.