CDSCO License for Implanted mechanical/hydrau lic urinary continence device
Medical Device Information
Intended Use
An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra.
Comprehensive Guide to CDSCO Licensing for Implanted Mechanical/Hydraulic Urinary Continence Devices
Implanted mechanical/hydraulic urinary continence devices are advanced internal prosthetic replacements designed to treat urinary incontinence by applying pressure to occlude the urethra either continuously or intermittently. Given their critical role in patient care and their invasive nature, these devices fall under Risk Class C as per the Indian Medical Device Rules, requiring stringent regulatory oversight by the Central Drugs Standard Control Organization (CDSCO).
With over 25 years of experience and having supported 500+ companies in navigating the Indian medical device regulatory environment, we offer a detailed roadmap for manufacturers and importers seeking to obtain the MD9 Manufacturing License and MD15 Import License for Class C devices like the implanted urinary continence system.
CDSCO Regulatory Framework for Implanted Mechanical/Hydraulic Urinary Continence Devices
The CDSCO regulates medical devices under the Medical Device Rules (MDR), 2017, which classify devices based on risk. Implanted mechanical/hydraulic urinary continence devices fall under Class C, requiring a centralized licensing approach via the CDSCO's Central Licensing Authority.
The governing notification for this device type is 29/Misc/3/2017-DC (292), dated 06.06.2018, which explicitly classifies internal prosthetic replacements as Class C. Consequently, all regulatory submissions and interactions for manufacturing or import licenses must comply with this classification.
Risk Classification and License Requirements
| Risk Class | Device Category | License Type | Licensing Authority | Approximate Timeline | Government Fees |
|---|---|---|---|---|---|
| Class C | Internal Prosthetic Replacements (Implantable) | MD9 Manufacturing | CDSCO Central Licensing Authority | 4-5 months | Rs. 50,000 per application + Rs. 1,000 per product |
Manufacturers of Class C devices are required to obtain the MD9 Manufacturing License (Application Form MD7), involving rigorous testing, documentation, and audits. Importers must secure the MD15 Import License.
Manufacturing License Process for Implanted Urinary Continence Devices (MD9)
The MD9 license process involves several critical steps:
Test License (Form MD13): Before applying for the manufacturing license, companies must obtain a test license, which permits product testing in government-approved labs. This step typically takes 1.5 to 2 months.
Product Testing: The device must undergo mandatory testing at CDSCO-approved laboratories to validate safety and performance. Testing duration depends on the lab and test complexity but generally aligns with the test license timeline.
Documentation Preparation: Concurrently, the manufacturer must prepare a comprehensive dossier, including quality management and technical documentation.
Application Submission (Form MD7): Submit the manufacturing license application on the CDSCO MD Online Portal.
Audit by CDSCO Inspectors: A thorough audit of manufacturing premises, quality systems, and documentation is conducted.
Query Resolution: Any queries raised during the audit or application review must be promptly addressed.
Grant of License (Form MD9): Upon successful completion, the MD9 manufacturing license is issued.
Total processing time for the MD9 license is approximately 4 to 5 months, including testing and audit.
Manufacturing License Documents Required
For implanted mechanical/hydraulic urinary continence devices, CDSCO mandates the following documentation:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical and Quality Personnel
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF): Detailed design and manufacturing process data. Our Device Master File guide offers step-by-step instructions.
- Plant Master File (PMF): Information on manufacturing facilities. Refer to our Plant Master File guide.
- Essential Principles Compliance Checklist
- Risk Management File demonstrating compliance with ISO 14971. Visit our Risk Management resource for best practices.
- Test Reports from CDSCO-approved labs. Check the Testing Laboratories list.
- Labeling and Instructions for Use (IFU) compliant with Indian regulations
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified
Import License Process (MD15) for Implanted Urinary Continence Devices
Importers of Class C devices must obtain an MD15 Import License through the following steps:
Document Preparation: Assemble all requisite documents as detailed below.
Application Submission (Form MD14): File the import license application via the CDSCO MD Online Portal.
Query Resolution: Respond promptly to any department queries.
License Grant: The MD15 import license is granted upon satisfactory review.
The import license approval timeline is approximately 5 to 6 months.
Import License Documents Required
Key documents for MD15 import license include:
- Valid Manufacturing License (MD9 for Indian manufacturers or equivalent foreign license)
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certification
- CE Certificate or equivalent international certification
- Device Master File and Plant Master File
- Wholesale Drug License for distribution
- Company Constitution and Incorporation Proof
Government fees vary by risk class; Class C devices attract:
- Rs. 3,000 per site
- Rs. 1,500 per product
Timeline and Processing Duration
| Stage | Duration Estimate |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | Concurrent with test license |
| Document Preparation | Ongoing during testing |
| MD9 License Application | Submission after testing |
| CDSCO Audit | 1 to 1.5 months |
| Query Resolution | 1 month |
| License Grant | Final step |
Total Time: Approximately 4 to 5 months from test license application to manufacturing license grant.
Import license timelines extend to about 5-6 months due to additional document verifications.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing | Rs. 50,000 | Rs. 1,000 |
| MD15 Import | Rs. 3,000 (per site) | Rs. 1,500 |
Additional costs include product testing fees at government-approved labs, audit preparation expenses, and consultancy fees if external experts are engaged.
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation or non-compliance with Essential Principles.
Solution: Ensure meticulous preparation of Device Master and Plant Master Files, robust risk management documentation, and compliance checklists before submission.
Challenge: Difficulty navigating the CDSCO MD Online Portal.
Solution: Engage a regulatory consultant experienced with the portal or utilize official training materials.
Challenge: Extended audit scheduling and queries.
Solution: Maintain an ISO 13485-compliant QMS and prepare your manufacturing site proactively for CDSCO audits.
Challenge: Product testing turnaround times.
Solution: Pre-select a CDSCO-approved testing laboratory from the Testing Laboratories list and plan timelines accordingly.
Expert Consultation and Support
With two and a half decades of regulatory expertise, we help manufacturers and importers streamline the licensing process for Class C devices like implanted mechanical/hydraulic urinary continence devices. Our services include:
- Comprehensive gap analysis against CDSCO requirements
- Preparation and review of Device and Plant Master Files
- Coordination with testing laboratories and notified bodies
- End-to-end application filing on the CDSCO MD Online Portal
- Audit readiness and post-audit support
Leveraging our proven track record mitigates risks of application rejection and accelerates market entry.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm your device falls under Class C using resources like the Medical Device Classification guide.
Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal to begin product testing.
Engage with CDSCO-Approved Testing Labs: Schedule and complete testing early to avoid bottlenecks.
Prepare Documentation: Utilize our Device and Plant Master File guides to curate a comprehensive dossier.
Plan Your Audit: Select a notified body from the Notified Bodies list or prepare for the CDSCO inspector audit.
Submit MD9 Manufacturing License Application: Upon successful testing and documentation, file Form MD7.
Monitor Application Progress and Respond Swiftly: Address queries to prevent delays.
Starting with these actionable steps will position your company for a smooth licensing journey and successful market entry of your implanted urinary continence device in India.
For personalized assistance and to leverage our extensive regulatory experience, contact our consultancy today and benefit from our tailored CDSCO licensing solutions.
