CDSCO License for Penis wearable urinal
Medical Device Information
Intended Use
A non-sterile, externally-worn, urine drainage device intended to be worn over the penis of an incontinent male patient to channel urine, via a tube, into a collection bag. It consists of a urinary incontinence penis attachment (e.g., sheath or adhesive port), tubing, and a wearable urine collection bag.
Comprehensive CDSCO Licensing Guide for Penis Wearable Urinal (Class B Medical Device)
Navigating the regulatory framework for medical devices in India can be complex, especially for specialized devices like the Penis Wearable Urinal. This device, classified as a Class B urology product, requires meticulous adherence to the Central Drugs Standard Control Organization (CDSCO) guidelines. With over 25 years of experience and having assisted 500+ companies in successful CDSCO license acquisitions, we provide you with an expert, practical roadmap to obtain your manufacturing or import license efficiently.
Understanding the Penis Wearable Urinal and Its Regulatory Importance
The Penis Wearable Urinal is a non-sterile, externally-worn urine drainage device designed for incontinent male patients. It includes a sheath or adhesive port, connecting tubing, and a wearable collection bag. Given its direct impact on patient health and comfort, regulatory oversight is crucial to ensure safety, quality, and performance. The device falls under the urology category and is notified under File No. 29/Misc./03/2020-DC (145) dated 23.8.2021.
Compliance with CDSCO regulations ensures that manufacturers/importers meet the essential principles of medical device safety and efficacy, thereby facilitating market access and patient trust.
CDSCO Regulatory Framework for Penis Wearable Urinal
In India, medical devices are regulated under the Medical Device Rules (MDR) 2017, enforced by CDSCO. The Penis Wearable Urinal is classified as a Class B device based on risk, which dictates the licensing pathway, inspection, and documentation requirements.
Class B devices require obtaining an MD5 manufacturing license from the State Licensing Authority if manufactured domestically, or an MD15 import license from CDSCO’s Central Licensing Authority if imported.
Risk Classification and License Requirements
- Risk Class: B
- License Type: MD5 for Manufacturing (State Authority), MD15 for Import (Central Authority)
- Application Forms: MD3 for MD5; MD14 for MD15
Class B devices carry moderate risk and typically require:
- Test license (MD13) before full license for manufacturing
- Product testing in government-approved laboratories
- Audit by notified bodies
For detailed classification, you can refer to the Medical Device Classification guide.
Manufacturing License Process for Penis Wearable Urinal (MD5)
The manufacturing license process for a Class B device, such as the Penis Wearable Urinal, involves several sequential steps:
Apply for Test License (Form MD13): This initial step allows sample testing. It usually takes 1.5 to 2 months for approval.
Product Testing: Conduct tests in CDSCO-approved laboratories to validate safety and performance. Access the list of testing laboratories.
Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, QMS, Risk Management File, and other regulatory documents.
Apply for Manufacturing License (Form MD3): Submit the application via the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by an approved notified body to verify compliance. Find notified bodies here.
Respond to Queries: Address any observations or queries from CDSCO or the notified body promptly.
Grant of License (Form MD5): Upon satisfactory review, the license is issued.
The entire process typically spans 3 to 4 months post test license issuance.
Manufacturing License Documents Required
To ensure a smooth application, prepare the following documents meticulously:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF): Includes design, specifications, and manufacturing details. Our Device Master File guide can assist.
- Plant Master File (PMF): Details facility layout, equipment, and utilities. Refer to our Plant Master File guide.
- Essential Principles Checklist: Demonstrates compliance with safety and performance standards.
- Risk Management File: Risk analysis and mitigation strategies relevant to the device. Learn more about risk management.
- Test Reports: From CDSCO-recognized labs.
- Labels and Instructions for Use (IFU): Must comply with Indian labeling regulations.
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and related SOPs.
Import License Process for Penis Wearable Urinal (MD15)
If you are an importer, the process differs slightly:
Document Preparation: Ensure you have the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, device and plant master files, and wholesale license.
Apply for Import License (Form MD14): Submit your application via the CDSCO MD Online Portal.
Queries Resolution: Respond promptly to departmental queries.
Grant of Import License (Form MD15): License is typically granted within 5 to 6 months.
Import License Documents Required
For import applications, gather the following:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate or Certificate of Market Authorization
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution
Timeline and Processing Duration
| License Type | Processing Time | Description |
|---|---|---|
| Test License (MD13) | 1.5 to 2 months | Required before MD5 license for manufacturing |
| MD5 License | 3 to 4 months post test license | Includes audit and query resolution |
| MD15 Import License | 5 to 6 months | No test license required |
Understanding these timelines helps plan your product launch strategically.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 Manufacturing | Rs 5,000 | Rs 500 per product |
| MD15 Import | USD 1,000 per site (Class B) | USD 1,000 per product |
Additional costs include product testing fees and notified body audit charges, which vary by service provider.
Common Challenges and Practical Solutions
- Delayed Test Reports: Engage with CDSCO-approved labs early and consider multiple lab options to avoid bottlenecks.
- Incomplete Documentation: Use comprehensive checklists and expert consultation to ensure all documents meet CDSCO expectations.
- Audit Non-Compliance: Pre-audit your facility and QMS thoroughly to minimize corrective actions during notified body audits.
- Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly and accurately to CDSCO queries.
Expert Consultation and Support
Navigating CDSCO licensing for devices like the Penis Wearable Urinal requires specialized knowledge. Our extensive experience enables us to provide:
- End-to-end regulatory strategy
- Document preparation and review
- Liaison with CDSCO and notified bodies
- Audit readiness and training
Leverage our expertise to reduce approval timelines and avoid costly rejections.
Getting Started with Your CDSCO License Application
Assess Your Product Classification: Confirm Class B status using the Medical Device Classification tool.
Prepare Documentation: Start compiling your Device Master File, Plant Master File, and Risk Management File.
Apply for Test License (MD13): Submit via the CDSCO MD Online Portal to initiate the process.
Schedule Product Testing: Engage CDSCO-approved labs early to avoid delays.
Plan for Audit: Identify and coordinate with a notified body from the official Notified Bodies List.
Maintain Open Communication: Regularly track your application status and promptly address any queries.
Embarking on your CDSCO licensing journey with clarity and expert guidance ensures your Penis Wearable Urinal reaches the Indian market efficiently and compliantly. Contact us today to leverage our 25+ years of regulatory expertise and streamline your approval process.
