CDSCO License for Female wearable urinal, reusable

Comprehensive Guide to CDSCO Licensing for Female Wearable Urinal (Reusable) – Class A Medical Device

Introduction: Understanding the Female Wearable Urinal and Its Regulatory Importance

The female wearable urinal, a reusable, non-sterile urology device, offers a discreet and hygienic solution for urine drainage in women. Designed with a flexible tube and collector tailored to fit female anatomy, it channels urine into a collection bag, improving comfort and independence for users. Given its direct contact with the body and intended medical use, regulatory compliance is essential to ensure safety, quality, and market access in India.

With the Central Drugs Standard Control Organization (CDSCO) notification (File No. 29/Misc./03/2020-DC (145), dated 23.8.2021), this device is classified as a Class A medical device under the urology category. This classification mandates a specific regulatory pathway to obtain the necessary manufacturing and import licenses.

CDSCO Regulatory Framework for Female Wearable Urinal

The regulatory framework for medical devices in India is overseen by CDSCO, which categorizes devices based on risk. For Class A devices like the female wearable urinal, the licensing authority is the State Licensing Authority, and the applicable manufacturing license is the MD5 license (Application Form MD3).

Our 25+ years of hands-on experience have shown that understanding and navigating this framework efficiently can significantly reduce time-to-market and regulatory hurdles.

Risk Classification and License Requirements

• Risk Class: A (Low risk)
• Regulatory Authority: State Licensing Authority
• Applicable License: MD5 Manufacturing License (Form MD3)
• Import License: MD15 (if importing)

Class A devices require adherence to essential principles of safety and performance, supported by robust documentation and quality management systems.

Manufacturing License Process (MD5) for Female Wearable Urinal

The MD5 license process involves several sequential steps:

1. Test License (Form MD13): Before applying for MD5, manufacturers must obtain a test license for the device. This license permits production of limited units for testing purposes.

2. Product Testing: Conduct testing at CDSCO-approved laboratories to validate safety and performance parameters. For the female wearable urinal, tests typically include biocompatibility, material safety, and functional performance.

3. Documentation Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System records.

4. Application Submission: Submit the MD5 application (Form MD3) through the CDSCO MD Online Portal.

5. Audit: A notified body will perform a facility audit to verify compliance with regulatory requirements. Check the list of notified bodies for applicable auditors.

6. Query Resolution: Respond promptly to any queries raised by the licensing authority or notified body.

7. License Grant: Upon satisfactory review, the State Licensing Authority issues the MD5 manufacturing license.

Manufacturing License Documents Required for Female Wearable Urinal

To streamline your application, ensure the following documents are prepared meticulously:

• Company Constitution (Memorandum & Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire No Objection Certificate (NOC) and Pollution NOC
• Device Master File (DMF) – detailed design and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) – facility and quality control procedures (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, typically ISO 13485:2016 compliant

Import License Process (MD15) for Female Wearable Urinal

If your business involves importing the female wearable urinal, the MD15 license from the Central Licensing Authority is mandatory. The process involves:

1. Document Preparation: Include import-specific documents such as Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), and existing manufacturing licenses.

2. Application Submission: File the application via the CDSCO MD Online Portal.

3. Review and Queries: Address any departmental queries comprehensively.

4. License Grant: The Central Licensing Authority issues the MD15 import license.

Note: Test licenses are not required for import applications.

Import License Documents Required

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

Timeline and Processing Duration

The timelines for licensing are critical for planning product launch and inventory management:

• MD5 Manufacturing License: Approximately 3-4 months

  • Test License (MD13): 1.5-2 months
  • Product Testing and Report Generation: 3-4 weeks
  • Application Processing and Audit: 1-1.5 months

• MD15 Import License: Approximately 5-6 months

Adhering to document quality and proactive query resolution can shorten these timelines.

Government Fees and Costs

For a Class A device like the female wearable urinal, the fee structure is as follows:

• MD5 License: Rs. 5,000 per application + Rs. 500 per product
• MD13 Test License: Included within the MD5 application process
• MD15 Import License: USD 1,000 per site + USD 50 per product

Budgeting for these fees upfront helps avoid application delays.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or inadequate test reports.

Solution: Engage expert consultants early to audit your documentation and select CDSCO-approved test labs.

Challenge: Audit non-compliance leading to repeated inspections.

Solution: Implement a robust QMS and prepare your facility per notified body checklists.

Challenge: Lack of clarity on device classification and licensing pathway.

Solution: Refer to the official Medical Device Classification guide to confirm device class.

Expert Consultation and Support

With over 500 successful CDSCO license applications facilitated, we understand the nuances unique to devices like the female wearable urinal. Our team offers tailored regulatory consulting, document preparation, liaison with notified bodies, and audit readiness support to ensure a smooth licensing journey.

Getting Started with Your CDSCO License Application

1. Assess your device classification and confirm licensing requirements. Our recommended starting point is reviewing the Medical Device Classification.

2. Prepare your Device Master File and Plant Master File with detailed design and manufacturing information. Refer to our comprehensive Device Master File guide and Plant Master File guide.

3. Initiate product testing at CDSCO-approved laboratories listed here: Testing Laboratories.

4. Apply for the test license (Form MD13) via the CDSCO MD Online Portal, and plan for the audit with a notified body from the Notified Bodies List.

5. Compile complete documentation and submit your manufacturing license application (Form MD3) online.

6. **Maintain open communication for timely resolution of any queries.

Embarking on this process with expert guidance can save months of effort and ensure compliance with India's stringent regulatory standards. Contact us to leverage our deep industry experience and achieve your CDSCO licensing goals efficiently.