CDSCO License for Hydraulic male urinary incontinence treatment system tubing plug
Medical Device Information
Intended Use
An implantable component of a hydraulic male urinary incontinence treatment system intended to seal the system’s tubing to prevent spillage/leakage of its contents when introduction/removal of fluid to/from the system’s pad (e.g., cushion, balloon) is not needed; it is typically made of metal.
Comprehensive CDSCO Licensing Guide for Hydraulic Male Urinary Incontinence Treatment System Tubing Plug (Class C Device)
As seasoned regulatory consultants with over 25 years of experience and 500+ successful CDSCO licensing projects, we understand the intricacies involved in obtaining approval for specialized medical devices. The hydraulic male urinary incontinence treatment system tubing plug, classified as a Class C implantable urology device, requires meticulous compliance under India's regulatory framework. This guide offers a step-by-step walkthrough tailored specifically for this device type to help manufacturers and importers confidently navigate the CDSCO licensing process.
CDSCO Regulatory Framework for Class C Urology Devices
India’s Central Drugs Standard Control Organisation (CDSCO) governs medical device regulation to ensure safety, efficacy, and quality. The hydraulic tubing plug falls under the urology category and is classified as Class C due to its implantable nature and moderate to high risk. Following the Medical Device Rules (MDR) 2017, CDSCO mandates rigorous evaluation before market entry.
The device’s regulatory compliance is anchored to Notification File No. 29/Misc./03/2020-DC (145) dated 23.8.2021, which outlines classification and regulatory pathways for such implantable components.
Risk Classification and License Requirements
Class C designation implies moderate to high risk, requiring a Central Licensing Authority-issued manufacturing license (MD9). This contrasts with Class A/B devices licensed at the state level (MD5). Importers also apply for the MD15 import license from CDSCO.
Here’s what that means for your hydraulic male urinary incontinence system tubing plug:
- Manufacturing License: MD9 (Form MD7 application)
- Import License: MD15 (Form MD14 application)
- Test License: MD13 (mandatory before manufacturing license)
- Auditing Authority: CDSCO central inspectors
For detailed classification reference, you may visit our Medical Device Classification guide.
Manufacturing License Process for MD9 (Class C Device)
Obtaining the MD9 manufacturing license is a multi-step process spanning approximately 4-5 months:
Test License Application (MD13): Submit Form MD13 via the CDSCO MD Online Portal to obtain a test license, allowing initial manufacturing for testing purposes. This takes about 1.5-2 months.
Product Testing: Conduct mandatory product testing at government-approved laboratories listed on the CDSCO Testing Laboratories page. Testing ensures compliance with performance and biocompatibility standards.
Document Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
Application Submission: File Form MD7 for the MD9 manufacturing license through the CDSCO portal.
Audit by CDSCO Inspectors: Schedule and undergo an on-site audit by CDSCO central inspectors assessing manufacturing premises, quality systems, and documentation.
Query Resolution: Address any queries raised by CDSCO or auditors promptly.
License Grant: Upon satisfactory review, the MD9 license is granted.
For a detailed walkthrough, our MD9 License Guide provides practical insights.
Manufacturing License Documents Required
The following documents are essential to support your MD9 license application:
- Company Constitution Documents: Memorandum and Articles of Association or equivalent
- Proof of Ownership or Lease: Valid documents for the manufacturing premises
- Technical Staff Qualifications: CVs and certificates of qualified personnel
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF): Detailed device design, specifications, and manufacturing process. Refer to our Device Master File guide for preparation tips.
- Plant Master File (PMF): Details of manufacturing facility and quality controls. Use our Plant Master File guide for compliance.
- Essential Principles Checklist: Declaration of conformity with Indian medical device standards
- Risk Management File: Documentation of risk assessment and mitigation strategies, vital for implantable devices. See our Risk Management resource.
- Test Reports: Certificates from government-approved labs
- Labels and Instructions for Use (IFU): Compliant with MDR labeling requirements
- Quality Management System Documents: ISO 13485:2016 certification and internal SOPs
Import License Process (MD15) for Class C Device
If you are importing the tubing plug, the MD15 import license from the Central Licensing Authority is mandatory. The timeline averages 5-6 months due to thorough document evaluation.
Steps include:
Document Compilation: Prepare manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE certificate, Device and Plant Master Files, wholesale license, and company constitution.
Application Submission: Apply via Form MD14 on the CDSCO MD Online Portal.
CDSCO Review and Queries: Respond promptly to any departmental queries.
License Issuance: Upon satisfactory review, MD15 license is granted.
For a comprehensive guide, refer to our Import License Guide.
Import License Documents Required
- Manufacturing license of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license for import
- Company constitution documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 1 month (concurrent) |
| Manufacturing License (MD9) | 1.5 – 2 months |
| Import License (MD15) | 5 – 6 months |
Note: Timelines may vary slightly based on query resolution speed and audit scheduling.
Government Fees and Costs
MD9 License Fees:
- Application Fee: ₹50,000 per application
- Product Fee: ₹1,000 per product
MD15 Import License Fees:
- Site Fee (Class C): $3,000 USD
- Product Fee (Class C): $1,500 USD per product
Additional costs include product testing fees charged by government-approved laboratories and audit-related expenses.
Common Challenges and Solutions
Delayed Test Reports: Plan testing well in advance and select experienced labs from the approved list.
Incomplete Documentation: Utilize comprehensive checklists and seek expert guidance to avoid common pitfalls.
Audit Non-conformities: Ensure robust QMS implementation and thorough internal audits before CDSCO inspection.
Query Resolution Delays: Assign dedicated regulatory personnel for prompt responses.
Labeling Non-compliance: Follow MDR labeling norms scrupulously, including bilingual instructions.
Expert Consultation and Support
With over two decades of expertise and a track record of assisting 500+ companies, we offer end-to-end CDSCO licensing services tailored for Class C implantable urology devices. Our support includes:
- Preparation and review of all regulatory documents
- Coordination with notified bodies and CDSCO officials
- Audit readiness training
- Product testing liaison
Our personalized approach minimizes delays and maximizes approval chances.
Getting Started with Your CDSCO License Application
To kickstart your licensing journey for the hydraulic male urinary incontinence treatment system tubing plug:
Register on the CDSCO MD Online Portal: Visit the official portal to create your account.
Compile Essential Documents: Begin gathering your company constitution, proof of premises, and technical staff details.
Develop Device and Plant Master Files: Draft detailed files using our expert guides.
Apply for Test License (MD13): Submit your application to initiate the testing phase.
Engage with Approved Testing Labs: Schedule product testing early to avoid bottlenecks.
Prepare for CDSCO Audit: Implement a compliant QMS and conduct mock audits.
Submit Manufacturing License Application (MD9): Once testing and documentation are complete.
Plan Import License Application (MD15): For importers, ensure all foreign regulatory documents are ready.
By following these practical steps and leveraging expert support, you can streamline your path to successful CDSCO licensing and confidently bring your innovative hydraulic urinary incontinence device to the Indian market.
For further assistance or personalized consulting, contact us to leverage our 25+ years of regulatory expertise.
