CDSCO License for Penis/scrotum wearable urinal

Comprehensive Guide to CDSCO Licensing for Penis/Scrotum Wearable Urinal (Class B Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized urology devices like a penis/scrotum wearable urinal. This device, intended as a non-sterile urine drainage solution for men with incontinence and retracted penis, falls under Class B risk classification according to CDSCO regulations. With over 25 years of experience and having assisted 500+ companies in securing CDSCO licenses, we provide you with a practical, step-by-step roadmap to obtain your manufacturing or import license efficiently.

CDSCO Regulatory Framework for Penis/Scrotum Wearable Urinals

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. Your device, categorized under urology and notified under File No. 29/Misc./03/2020-DC (145) dated 23.8.2021, is classified as Class B. This classification mandates a State Licensing Authority approval for manufacturing licenses, typically via the MD5 license route.

Risk Classification and License Requirements

As a Class B device, you must secure an MD5 manufacturing license to legally manufacture the device in India. The MD5 license process includes obtaining a test license (MD13), product testing, audit by notified bodies, and final license grant.

Manufacturing License Process (MD5)

1. Obtain Test License (Form MD13): The initial step involves applying for a test license, which grants you permission to manufacture the device for testing and evaluation. This process typically takes 1.5 to 2 months.

2. Product Testing: After the test license, the device samples must be tested at CDSCO-approved laboratories. Testing ensures compliance with standards related to safety, performance, and quality. You can refer to the list of CDSCO approved testing laboratories.

3. Documentation and Application for MD5 (Form MD3): Collate all required documents and submit your manufacturing license application online via the CDSCO MD Online Portal.

4. Audit by Notified Body: A mandatory audit by a notified body is conducted. Check the list of notified bodies authorized for MD5 audits to select and appoint one.

5. Query Resolution: Address any queries or deficiencies raised by the licensing authority or notified body promptly.

6. Grant of License: Upon satisfactory review and audit, you will be issued the MD5 manufacturing license (Form MD5).

Manufacturing License Documents Required

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

• Company Constitution (e.g., MOA, AOA)
• Proof of premises ownership or lease agreement
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC for the manufacturing site
• Device Master File (DMF): Include detailed design, specifications, and manufacturing process. Our Device Master File guide offers comprehensive insights.
• Plant Master File (PMF): Documentation of manufacturing environment, equipment, and quality systems. Learn more from our Plant Master File guide.
• Essential Principles Checklist as per MDR 2017
• Risk Management File that addresses potential risks associated with device use. Refer to our Risk Management resource.
• Test Reports from CDSCO-approved labs
• Labels, Instructions for Use (IFU), and packaging details
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification or equivalent

Import License Process (MD15)

If you're an importer of the penis/scrotum wearable urinal, the process differs slightly:

• No test license is required.
• Submit an application on Form MD14 via the CDSCO MD Online Portal.
• Provide documents including Manufacturing License, Free Sale Certificate from the country of origin, ISO 13485:2016, CE certificates, DMF, PMF, Wholesale License, and Company Constitution.
• The licensing authority is Central Licensing Authority, and the process takes approximately 5-6 months.
• Government fees are based on risk class; for Class B devices, expect $2000 per site and$1000 per product.

For detailed guidance, please refer to our Import License guide.

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): Nominal fees payable as per CDSCO guidelines
• MD5 Manufacturing License: Rs. 5000 per application
• Per Product Fee: Rs. 500
• Audit and Testing Costs: Variable depending on notified body and test lab charges (typically Rs. 1-2 lakhs including all tests)

Budget accordingly for comprehensive compliance and ensure timely payments to avoid application delays.

Common Challenges and Solutions

• Delayed Testing Results: Plan ahead and engage with approved testing labs early to schedule sample analysis.
• Incomplete Documentation: Use checklists and expert reviews to ensure all documents, especially DMF and PMF, meet CDSCO standards.
• Audit Non-Compliance: Prepare your QMS and manufacturing site thoroughly; conduct internal audits before the notified body visit.
• Query Resolution Delays: Respond promptly and comprehensively to queries raised by authorities to avoid prolonged processing times.

Expert Consultation and Support

With decades of regulatory consulting experience, we've guided over 500 companies through the CDSCO licensing maze. Our expertise covers document preparation, liaison with notified bodies, test lab coordination, and audit readiness. We offer tailored support to ensure your penis/scrotum wearable urinal device meets all compliance requirements efficiently.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal to create your account for online application submission.

2. Prepare your Test License (MD13) application with all supporting documents to initiate the process.

3. Engage with a notified body early to schedule your audit post-testing phase.

4. Coordinate with CDSCO-approved testing labs to plan and execute required product testing.

5. Develop and review your Device and Plant Master Files alongside risk management and QMS documentation.

6. Submit your MD5 license application (Form MD3) once test license and testing phases are complete.

7. Maintain proactive communication with the licensing authority to address any queries swiftly.

Embarking on your regulatory journey with a clear, actionable plan significantly increases your chances of timely license approval. Contact us today for personalized assistance and ensure seamless compliance for your penis/scrotum wearable urinal device in the Indian market.