CDSCO License for Hand-held urinal, male, reusable

Comprehensive Guide to CDSCO Licensing for Hand-held Male Urinal (Reusable) – Class A Medical Device

At our consultancy, with over 25 years of deep expertise and having supported more than 500 manufacturers, we understand the unique regulatory landscape for medical devices in India. The hand-held male urinal, a Class A reusable urology device, is a vital healthcare aid for bed-bound patients. Ensuring its regulatory compliance through CDSCO licensing is crucial for legal marketing and sustained business growth in India.

Understanding the Hand-held Male Urinal and Regulatory Importance

This device serves as a portable, hygienic container designed specifically for male patients' excretory needs. Given its direct bodily contact and repeated use, it falls under Class A, the lowest risk category according to CDSCO's classification. Despite its low risk, obtaining the MD5 manufacturing license is mandatory before commercial distribution.

Why is regulatory compliance critical? It ensures product safety, quality, and efficacy, protecting end-users and establishing your brand’s credibility in a highly regulated market.

CDSCO Regulatory Framework for Class A Medical Devices

The Central Drugs Standard Control Organization (CDSCO) governs medical device licensing in India, categorizing devices into Class A, B, C, and D based on risk. For the hand-held male urinal, the MD5 license issued by the State Licensing Authority applies. The licensing process encompasses several stages including test license acquisition, product testing, documentation, audit, and final license grant.

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

Risk Classification and License Requirements for Hand-held Male Urinal

• Device Name: Hand-held urinal, male, reusable
• Risk Class: A (Low Risk)
• Category: Urology
• Relevant License: MD5 Manufacturing License
• Application Form: MD3 for license, MD13 for test license

Step-by-Step Manufacturing License Process (MD5) for Class A Device

1. Obtain Test License (Form MD13):

   • Duration: Approximately 1.5 to 2 months
   • Purpose: Permission to manufacture and send product samples for testing

2. Product Testing:

   • Conducted at CDSCO-approved laboratories (see Testing Laboratories list)
   • Tests focus on biocompatibility, material safety, and functional performance

3. Document Preparation:

   • Compile all mandatory documentation including Device Master File, Plant Master File, Risk Management File, and QMS documents

4. Application Submission (Form MD3):

   • Submit through the CDSCO MD Online Portal

5. Audit by Notified Body:

   • State-appointed notified body conducts a thorough audit
   • Reference the Notified Bodies list to identify authorized auditors

6. Resolution of Queries:

   • Address any clarifications or corrective actions requested by the department or notified body

7. Grant of MD5 License:

   • Once all criteria are met, the license is issued on Form MD5

For an in-depth understanding, review our MD5 License Guide.

Essential Documents Required for MD5 License Application

• Company Constitution documents (e.g., MOA, AOA)
• Proof of ownership or lease of manufacturing premises
• Details and qualification certificates of technical and quality staff
• Fire and Pollution NOCs
• Device Master File: Detailed specifications, design, and intended use (Guide here)
• Plant Master File: Manufacturing processes, equipment, and quality controls (Guide here)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management Guide)
• Test reports from CDSCO-approved testing laboratories
• Labeling and Instructions for Use (IFU) compliant with regulatory standards
• Quality Management System (QMS) documentation compliant with ISO 13485

Import License Process (MD15) – Not Applicable for Manufacturing

Since the hand-held male urinal in this context is manufactured domestically, import license (MD15) is not required. However, for importers, the MD15 license is issued by the Central Licensing Authority and generally takes 5-6 months for processing.

Timeline and Processing Duration for MD5 License

• Test License (MD13): 1.5 to 2 months
• Product Testing: Concurrent with or immediately after test license issuance, typically 1 month
• Document Preparation and Submission: 2-3 weeks
• Audit and Queries Resolution: 1 to 1.5 months

Total expected duration: 3 to 4 months from application initiation to license grant

Government Fees and Associated Costs

• Application Fee: ₹5,000 per application
• License Fee: ₹500 per product

Additional costs may include:

• Testing fees charged by approved laboratories
• Audit fees payable to notified bodies
• Consultancy fees if opting for expert assistance

Common Challenges and Practical Solutions

• Incomplete Documentation: Missing or inaccurate technical files often delay audits. Solution: Meticulously prepare and cross-verify all documents; use checklists.
• Audit Non-compliance: Non-adherence to Good Manufacturing Practices (GMP) or QMS gaps can cause audit failures. Solution: Conduct pre-audit internal reviews and training.
• Delayed Product Testing: Limited slots in government-approved labs can extend timelines. Solution: Schedule testing promptly after test license issuance.
• Query Management Delays: Slow response to regulatory queries can stall approvals. Solution: Assign dedicated personnel to handle queries promptly.

Expert Consultation and Support

Navigating CDSCO licensing can be complex. Our experienced regulatory consultants help you streamline application preparation, coordinate with notified bodies, and manage audits efficiently. We provide tailored solutions to expedite approvals and minimize compliance risks.

Getting Started with Your CDSCO License Application for Hand-held Male Urinal

1. Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the submission interface. (CDSCO MD Online Portal)

2. Prepare Test License Application (Form MD13): Gather all preliminary documents and product samples.

3. Engage with CDSCO-Approved Testing Labs: Plan your product testing in advance to avoid bottlenecks.

4. Compile Comprehensive Documentation: Use our Master File guides to prepare your Device and Plant Master Files.

5. Schedule and Prepare for Audit: Select notified bodies from the official list and conduct internal audits.

6. Submit MD5 License Application (Form MD3): Upload necessary documents and track application status.

7. Respond Promptly to Queries: Maintain communication with CDSCO and auditors to facilitate a smooth license grant.

By following these practical steps and leveraging our expert guidance, manufacturers of hand-held male urinals can confidently navigate the CDSCO licensing process and achieve timely market authorization.

For more detailed assistance, feel free to contact our regulatory experts who have successfully guided 500+ companies through India's medical device regulatory landscape.