CDSCO License for Diaphragm wearable urinal
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A non-sterile urine drainage device designed for men with incontinence consisting of a front piece with a scrotal support and a leak-proof, flexible diaphragm through which the penis passes into a closed cone- shaped tube connected to a leg bag into which the urine is collected.

Introduction to Diaphragm Wearable Urinal and Regulatory Importance
The diaphragm wearable urinal is a specialized urology medical device designed to assist men with urinary incontinence. This device features a scrotal support and a leak-proof, flexible diaphragm that channels urine through a cone-shaped tube into a connected leg bag for discreet and hygienic urine collection. Given its critical role in patient care, ensuring regulatory compliance is essential to guarantee safety, efficacy, and market authorization in India.
Navigating the Central Drugs Standard Control Organization (CDSCO) licensing framework is mandatory for manufacturers and importers seeking to market this Class A medical device in India. We bring over 25 years of regulatory consultancy experience, having facilitated 500+ companies in successfully obtaining CDSCO licenses, including for devices within the urology category like the diaphragm wearable urinal.
CDSCO Regulatory Framework for Diaphragm Wearable Urinals
Under the Medical Device Rules, 2017 (MDR 2017), the diaphragm wearable urinal is classified as a Class A device due to its non-invasive nature and low risk profile. The regulatory oversight for manufacturing and importing such devices falls predominantly under the State Licensing Authority for manufacturing and the Central Licensing Authority for import.
Key points:
- Device Notification: File No. 29/Misc./03/2020-DC (145), dated 23.8.2021
- Category: Urology
- Risk Class: A (Low risk)
Manufacturers must apply for an MD5 manufacturing license, while importers require an MD15 import license.
Risk Classification and License Requirements
The diaphragm wearable urinal is classified as Class A, which entails:
- Manufacturing License: MD5 License (Application Form MD3)
- Issuing Authority: State Licensing Authority
- Timeline: Approximately 3-4 months
- Fees: Rs. 5,000 per application + Rs. 500 per product
For importers:
- Import License: MD15 License (Application Form MD14)
- Issuing Authority: Central Licensing Authority
- Timeline: Approximately 5-6 months
- Fees: 50 per product
Manufacturing License Process (MD5 License for Class A Devices)
The MD5 license process is methodical and involves several critical steps to ensure compliance and quality assurance:
Test License (MD13 Application): Before applying for the MD5 license, manufacturers must obtain a test license (MD13), allowing sample testing. This typically takes 1.5 to 2 months.
Product Testing: The device sample must be tested at a CDSCO-approved government laboratory to validate safety and performance. Refer to the list of testing laboratories authorized by CDSCO.
Document Preparation: Assemble all required documentation, including Device Master File and Plant Master File.
Application Submission: Submit the MD5 manufacturing license application (Form MD3) through the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by an accredited notified body to assess quality management systems and manufacturing processes. You can view the list of notified bodies for audit requirements.
Queries and Clarifications: Respond promptly to any questions or deficiencies raised by the department or notified body.
License Grant: Upon satisfactory review and audit, the MD5 license is granted.
Manufacturing License Documents Required for Diaphragm Wearable Urinal
Successful application requires meticulous documentation. Essential documents include:
- Company Constitution (e.g., Certificate of Incorporation)
- Proof of Ownership or Lease Agreement for Manufacturing Premises
- Technical Staff Qualification and Experience Documents
- Fire and Pollution NOCs
- Device Master File (DMF) detailing design, specifications, and manufacturing processes (Device Master File Guide)
- Plant Master File describing the manufacturing environment and quality systems (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with safety and performance standards
- Risk Management File showcasing hazard identification and mitigation strategies (Risk Management Guide)
- Test Reports from government-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485 certified
Import License Process (MD15 License)
Importing diaphragm wearable urinals into India requires the MD15 license granted by the Central Licensing Authority:
Document Preparation: Gather all relevant documents including manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE certificate, and device-specific documentation.
Application Submission: Submit the MD15 license application (Form MD14) via the CDSCO MD Online Portal.
Query Resolution: Address any clarifications or deficiencies raised by CDSCO officials.
License Issuance: Upon compliance, the import license is issued.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate/Certificate of Marketing Authorization
- ISO 13485:2016 Certification
- CE Certificate if applicable
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
License Type | Process Steps | Approximate Duration |
---|---|---|
Test License (MD13) | Sample Testing Authorization | 1.5 - 2 months |
Manufacturing License (MD5) | Document Review, Audit, Approval | 3 - 4 months (including test license) |
Import License (MD15) | Document Review, Approval | 5 - 6 months |
Manufacturers should factor in testing and audit timelines when planning market entry.
Government Fees and Costs
- MD5 License: Rs. 5,000 per application + Rs. 500 per product
- MD15 Import License:
- Class A: 50 per product
Additional costs include fees for audits by notified bodies, testing laboratory charges, and any consultancy support.
Common Challenges and Solutions
Delayed Testing Results: Coordinate early with CDSCO-approved labs and submit samples promptly to avoid bottlenecks.
Incomplete Documentation: Utilize detailed checklists and consult comprehensive guides such as our MD5 License Guide to ensure completeness.
Audit Non-Compliance: Engage experienced professionals for pre-audit assessments and ensure your QMS aligns with regulatory expectations.
Query Resolution Delays: Assign dedicated regulatory personnel to respond swiftly to CDSCO queries.
Expert Consultation and Support
With our extensive experience assisting over 500 medical device companies, including those manufacturing and importing urology devices like diaphragm wearable urinals, we offer tailored regulatory consultancy. Our services include:
- End-to-end application preparation and submission
- Document drafting and review (DMF, PMF, Risk Management Files)
- Coordination with notified bodies and testing labs
- Pre-audit readiness assessments
- Regulatory strategy and compliance advisory
Leveraging expert support can significantly reduce approval timelines and ensure regulatory compliance.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm the diaphragm wearable urinal as a Class A device per CDSCO guidelines (Medical Device Classification).
Obtain Test License (MD13): Apply early for the test license via the CDSCO MD Online Portal.
Sample Testing: Coordinate with authorized labs to test your device.
Prepare Documentation: Develop robust Device Master and Plant Master Files along with risk management documentation.
Engage Notified Body: Schedule and prepare for the mandatory audit.
Submit MD5 License Application: Apply through the CDSCO portal and monitor status diligently.
Respond to Queries: Address any CDSCO or notified body queries promptly.
Plan Import Licensing: If importing, concurrently prepare for MD15 application to avoid market delays.
By following these detailed steps and leveraging expert guidance, manufacturers and importers of diaphragm wearable urinals can confidently navigate the CDSCO regulatory landscape and successfully enter the Indian market.
For personalized assistance or to discuss your specific device requirements, contact our regulatory experts today.