CDSCO License for Incontinence penis clamp, reusable
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 male urinary incontinence device designed to gently compress the penis, either the proximal shaft or the glans penis, to occlude the urethra and prevent involuntary urination/dribbling for men who are incontinent of the bladder.
Introduction to Incontinence Penis Clamp and Its Regulatory Importance
The incontinence penis clamp, reusable, is a critical urology device designed specifically for men experiencing urinary incontinence. By gently compressing the penis at the proximal shaft or glans, this device occludes the urethra to prevent involuntary urination or dribbling, significantly improving the quality of life for patients. Given its intended medical use, this device is regulated under India's Central Drugs Standard Control Organization (CDSCO) framework to ensure safety, efficacy, and quality before it reaches the market.
For manufacturers and importers, understanding the regulatory pathway for this Class A medical device is essential to achieve timely approval and compliance with Indian regulations. With over 25 years of experience assisting 500+ companies in CDSCO licensing, we provide a detailed roadmap tailored to this device category.
CDSCO Regulatory Framework for Incontinence Penis Clamps (Class A Devices)
Under the CDSCO's medical device regulations, incontinence penis clamps fall under Class A (low risk) devices due to their non-invasive nature and limited risk profile. The regulatory framework mandates a stepwise approach involving product testing, documentation, audits, and licensing through the State Licensing Authority.
The relevant notification governing this device is File No. 29/Misc./03/2020-DC (145), dated 23.08.2021, which outlines classification and licensing requirements under the Medical Device Rules, 2017.
Risk Classification and License Requirements
- Device Risk Class: Class A (Low Risk)
- License Type: MD5 Manufacturing License
- Governing Authority: State Licensing Authority
Class A devices require an MD5 license, which is obtained after completing a test license, product testing from CDSCO-approved labs, an audit by a notified body, and submission of comprehensive documentation.
Manufacturing License Process (MD5) for Incontinence Penis Clamp
The MD5 license process for Class A devices like the incontinence penis clamp typically spans 3 to 4 months and involves the following stages:
- Test License (Form MD13): Apply for the test license to conduct product testing, which takes approximately 1.5 to 2 months.
- Product Testing: Conduct testing at CDSCO-approved laboratories to validate safety and performance.
- Documentation Preparation: Compile necessary technical and quality documents.
- Application Submission (Form MD3): Submit the manufacturing license application.
- Audit: Undergo a mandatory audit by a notified body.
- Resolution of Queries: Address any questions or deficiencies raised by the licensing authority or notified body.
- Grant of License (Form MD5): Receive the final manufacturing license.
You can conveniently submit your application through the CDSCO MD Online Portal.
Manufacturing License Documents Required
For the incontinence penis clamp, the following documents must be meticulously prepared and submitted:
- Company Constitution: Proof of legal business entity.
- Proof of Ownership or Tenancy of Premises: Legal documents indicating manufacturing site ownership.
- Technical Staff Qualification Documents: CVs and certifications of key technical personnel.
- Fire and Pollution NOCs: Certificates from local authorities ensuring compliance.
- Device Master File (DMF): Detailed device description, design, and specifications. Our comprehensive Device Master File guide can assist in preparation.
- Plant Master File (PMF): Documentation of manufacturing processes and facilities. Refer to our Plant Master File guide for best practices.
- Essential Principles Checklist: Compliance verification with Indian medical device standards.
- Risk Management File: Analysis and mitigation strategies, critical even for Class A devices. Learn more about Risk Management.
- Test Reports: Certificates from CDSCO-approved testing laboratories confirming device safety and efficacy. A list of approved Testing Laboratories is available.
- Labels and Instructions for Use (IFU): Device labeling as per regulatory requirements.
- Quality Management System (QMS) Documents: SOPs, quality manuals, and records demonstrating compliance with ISO 13485:2016.
Import License Process (MD15) for Incontinence Penis Clamps
Although your device is Class A and primarily involves manufacturing licensing, importers must apply for an MD15 Import License through the Central Licensing Authority. This process generally takes 5 to 6 months and requires:
- Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device and Plant Master Files
- Wholesale License
- Company Constitution
Application submission is done via the CDSCO MD Online Portal using Form MD14. Detailed guidance is available in our Import License guide.
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 2 - 3 weeks |
| Documentation Prep | 1 - 2 weeks |
| Application Submission | Immediate upon prep |
| Audit and Evaluation | 3 - 4 weeks |
| Query Resolution | 2 - 3 weeks |
| License Granting | Within 1 week post-approval |
Total Expected Time: Approximately 3 to 4 months for complete MD5 licensing.
Government Fees and Costs
For Class A devices such as the incontinence penis clamp, the fee structure is as follows:
- Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product
These fees are payable online via the CDSCO MD Online Portal during application submission.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage early with CDSCO-approved labs and pre-schedule testing to avoid bottlenecks.
Challenge 2: Incomplete Documentation
- Solution: Utilize expert templates for Device and Plant Master Files and perform a thorough internal audit before submission.
Challenge 3: Audit Non-compliance
- Solution: Conduct mock audits and ensure your QMS aligns with ISO 13485:2016 standards.
Challenge 4: Query Resolution Delays
- Solution: Establish a dedicated regulatory response team to address queries promptly.
Expert Consultation and Support
Navigating CDSCO regulations can be complex, especially with evolving standards and procedural nuances. Our team, with over 25 years of experience and 500+ successful client licenses, offers comprehensive support—from gap analysis and documentation preparation to audit facilitation and post-license compliance.
We provide personalized consulting tailored to urology devices like the incontinence penis clamp, ensuring your regulatory journey is smooth and predictable.
Getting Started with Your CDSCO License Application
To begin your licensing process for the incontinence penis clamp:
- Register on the CDSCO MD Online Portal to create your account.
- Prepare your test license application (Form MD13) and gather initial documents.
- Identify an accredited CDSCO testing laboratory early to schedule product testing.
- Develop your Device Master File and Plant Master File using expert guides linked above.
- Engage with a notified body listed in the Notified Bodies List for audit readiness.
- Plan your timeline carefully to accommodate each step, factoring in potential queries.
By following these steps and leveraging professional expertise, manufacturers and importers can confidently bring the incontinence penis clamp to the Indian market with full regulatory compliance and minimal delays.
