CDSCO License for Hand-held urinal, female
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 portable, hand-held container/set, typically made of plastic, intended to be directly urinated into by a female (typically bed-bound) patient for excretory purposes.
Comprehensive Guide to CDSCO Licensing for Hand-held Female Urinal (Class A Medical Device)
Navigating the regulatory landscape for medical devices in India can be challenging, especially for manufacturers and importers aiming to launch products like the Hand-held Female Urinal. This device, classified as a Class A medical device under the CDSCO framework, is a portable, plastic container designed for female patients—especially those bedridden—to facilitate hygienic urination. With over 25 years of regulatory consulting experience and having supported 500+ companies, we provide you with a practical, step-by-step guide to secure your CDSCO license efficiently.
Understanding the CDSCO Regulatory Framework for Hand-held Female Urinals
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Drug and Cosmetics Act. The Hand-held Female Urinal falls under the urology category and is notified under File No. 29/Misc./03/2020-DC (145), dated 23.08.2021. As a Class A device, it is considered low risk, which means regulatory requirements focus primarily on safety, quality, and essential principles compliance.
Risk Classification and License Requirements for Your Device
Class A devices like the Hand-held Female Urinal require a Manufacturing License (MD5 License) issued by the State Licensing Authority. This license process ensures your manufacturing facility complies with Good Manufacturing Practices (GMP) and that your product meets Indian safety and performance standards.
Check the detailed medical device classification guide to confirm your device's classification and regulatory route.
Step-by-Step Manufacturing License Process (MD5 License)
Test License Application (Form MD13): Before applying for the manufacturing license, you must obtain a test license to produce limited quantities for testing purposes. This takes approximately 1.5 to 2 months.
Product Testing: Submit your Hand-held Female Urinal samples to CDSCO-approved government testing laboratories for evaluation of safety and compliance. Refer to the official Testing Laboratories list.
Document Preparation: Prepare comprehensive documentation, including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System documents.
License Application Submission (Form MD3): Apply for the MD5 manufacturing license through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will conduct an audit of your manufacturing site to ensure compliance with regulatory standards. Find relevant notified bodies on the Notified Bodies List.
Queries and Clarifications: Respond promptly to any queries raised by the authorities or notified body during the review.
Grant of License (Form MD5): Upon successful audit and document verification, you will be granted the manufacturing license.
For an in-depth overview, see our MD5 License Guide.
Essential Documents Required for MD5 License Application
- Company Constitution: Incorporation certificate, partnership deed, or proprietorship details.
- Proof of Ownership or Lease Agreement: Valid documentation of the manufacturing premises.
- Technical Staff Credentials: Qualification and experience certificates of the technical personnel involved.
- Fire NOC and Pollution Control Board NOC: Compliance certificates for safety and environmental standards.
- Device Master File (DMF): Detailed description of the Hand-held Female Urinal design, materials, manufacturing process, and testing. Our Device Master File guide can help streamline this.
- Plant Master File (PMF): Comprehensive details about manufacturing infrastructure, machinery, and quality controls. Refer to our Plant Master File guide.
- Essential Principles Checklist: Compliance with Indian and international safety guidelines.
- Risk Management File: Documented risk assessment and mitigation strategies per risk management best practices.
- Test Reports: Certificates from government-approved labs confirming product safety.
- Labels and Instructions for Use (IFU): Clear, compliant product labeling and user instructions.
- Quality Management System (QMS) Documents: ISO 13485 certification or equivalent system documentation.
Import License Process for Hand-held Female Urinals (If Applicable)
If you plan to import the Hand-held Female Urinal into India, an Import License (MD15 License) is mandatory, issued by the CDSCO Central Licensing Authority. The process involves:
- Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485, CE Certificate, DMF, PMF, and wholesale license.
- Application submission on the CDSCO MD Online Portal.
- Queries resolution and final license grant within 5-6 months.
For detailed import licensing procedures, consult our Import License Guide.
Timeline and Processing Duration
- Test License (MD13): 1.5 to 2 months
- Product Testing: 4 to 6 weeks, depending on laboratory workload
- Document Preparation: 3 to 4 weeks (parallel with testing)
- Audit and License Application (MD5): 1.5 to 2 months
Total Estimated Time: Approximately 3 to 4 months from start to finish for manufacturing license.
Government Fees and Costs Breakdown
- Application Fee: Rs. 5000 per MD5 license application
- Product Fee: Rs. 500 per product (each variant of Hand-held Female Urinal)
Additional costs may include:
- Testing laboratory fees
- Notified body audit charges
- Document preparation and consultancy fees
Common Challenges and Practical Solutions
- Delayed Testing Reports: To avoid bottlenecks, submit samples early and confirm testing timelines with labs.
- Incomplete Documentation: Use checklists and templates for DMF and PMF to ensure completeness.
- Audit Non-compliance: Conduct internal audits and pre-audit readiness checks to address gaps beforehand.
- Technical Staff Qualification: Ensure staff meet CDSCO criteria and maintain updated records.
Our experience shows proactive planning and close coordination with notified bodies and testing labs significantly smoothens the licensing journey.
Expert Consultation and Support
Given the complexities involved, partnering with an experienced regulatory consultant can save you time and prevent costly errors. We have helped over 500 companies successfully navigate CDSCO licensing for Class A devices like the Hand-held Female Urinal, providing tailored support from documentation to audit readiness.
Getting Started with Your CDSCO License Application
To initiate your licensing process:
- Register your company and manufacturing site on the CDSCO MD Online Portal.
- Prepare and submit the Test License application (MD13) to begin limited manufacturing.
- Coordinate sample testing with CDSCO-approved labs.
- Compile your Device and Plant Master Files along with risk management and QMS documentation.
- Plan your notified body audit well in advance with the help of the official Notified Bodies List.
Starting early and following a structured approach will ensure you meet all regulatory requirements efficiently, enabling faster market access for your Hand-held Female Urinal.
For personalized assistance and comprehensive regulatory solutions, feel free to reach out to our expert team. We’re committed to helping you succeed in the Indian medical device market.
