CDSCO License for Implantable incontinence- control electrical stimulation system
Medical Device Information
Intended Use
An assembly of battery-powered devices intended to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence, through the application of electrical stimuli to the muscles and/or neural tissue of the pelvic floor/bladder.
Implantable Incontinence-Control Electrical Stimulation System: Regulatory Overview and CDSCO Licensing Guide
Manufacturers and importers eyeing the Indian market for implantable incontinence-control electrical stimulation systems—advanced battery-powered devices used to treat chronic pelvic and lower urinary tract disorders—must navigate the rigorous Central Drugs Standard Control Organization (CDSCO) regulatory framework. Our 25+ years of experience, having successfully guided over 500 companies, equips us to demystify licensing requirements for this Class C gastroenterology device.
CDSCO Regulatory Framework for Implantable Electrical Stimulation Systems
The CDSCO classifies medical devices based on risk, with implantable electrical stimulation systems categorized as Class C, reflecting moderate-to-high risk due to their invasive nature and critical therapeutic role. The regulatory approach involves centralized licensing, stringent testing, and comprehensive documentation to ensure safety and efficacy.
This device is notified under Notification 29/Misc./03/2020-DC (182), dated 27.09.2021, reinforcing its regulatory status in India.
Risk Classification and License Requirements for Class C Devices
Class C devices require obtaining an MD9 manufacturing license from the CDSCO Central Licensing Authority. Importers must secure an MD15 import license, also issued centrally.
- MD9 License: Mandatory for manufacturing within India. Application via Form MD7.
- MD15 License: Required for importing the device. Application via Form MD14.
Manufacturing License Process (MD9) for Implantable Electrical Stimulation Systems
Our structured approach to obtaining the MD9 license ensures compliance and expedites approval:
- Test License (Form MD13): Begin with a test license application to conduct product testing, typically taking 1.5-2 months.
- Product Testing: Conduct mandatory testing at CDSCO-approved laboratories. Refer to the Testing Laboratories list for accredited facilities.
- Document Preparation: Assemble comprehensive dossiers including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
- MD9 License Application (Form MD7): Submit completed application via the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: Undergo on-site inspection for compliance verification.
- Query Resolution: Address any queries raised by authorities promptly to avoid delays.
- License Grant: Upon successful review, receive the MD9 manufacturing license.
Manufacturing License Documents Required for Class C Devices
The documentation checklist includes:
- Company Constitution and Incorporation Certificate
- Proof of ownership or lease of manufacturing premises
- Details and credentials of technical and managerial staff
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF) detailing design, manufacturing, and safety data (Guide to Device Master Files)
- Plant Master File (PMF) covering manufacturing facilities and processes (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with Indian medical device standards
- Risk Management File highlighting hazard analysis and mitigation strategies (Risk Management Insights)
- Test Reports from CDSCO-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System documentation, preferably ISO 13485:2016 certification
Import License Process (MD15) for Implantable Electrical Stimulation Systems
Importers must follow these steps to secure the MD15 license:
- Document Compilation: Unlike manufacturing, no test license is required. Prepare all mandatory documents.
- Application Submission: File the application on Form MD14 via the CDSCO MD Online Portal.
- Query Handling: Respond promptly to regulatory queries.
- License Grant: Receive the import license (MD15) upon approval.
Import License Documents Required
Key documents include:
- Valid Manufacturing License of the product in the country of origin
- Free Sale Certificate demonstrating the device's market authorization abroad
- ISO 13485:2016 Certification
- CE Certificate or equivalent international safety certification
- Device Master File and Plant Master File
- Wholesale License for distribution in India
- Company Constitution and Registration Proof
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| MD9 Manufacturing | 4 to 5 months (including test license, audit, and queries) |
| MD15 Import | 5 to 6 months |
From initial application to license grant, manufacturers can expect a 4-5 month timeframe for MD9 and 5-6 months for MD15, assuming timely submission and responsive communication.
Government Fees and Costs
For Class C implantable devices:
MD9 Manufacturing License Fees:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
MD15 Import License Fees:
- Site Fee: ₹3,000
- Per Product Fee: ₹1,500
Additional costs include testing fees at accredited labs and audit charges by notified bodies. These investments ensure compliance and market access.
Common Challenges and Solutions
Challenge 1: Complex Documentation Preparation
- Solution: Utilize detailed checklists and expert templates for Device Master File and Risk Management File. Our Plant Master File Guide can simplify facility documentation.
Challenge 2: Delays in Product Testing
- Solution: Pre-schedule tests with CDSCO-approved labs to avoid backlog. Consult the Testing Laboratories list for available options.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal audits and mock inspections. Engage accredited notified bodies for pre-audit consultancy. Refer to the Notified Bodies List for authorized agencies.
Expert Consultation and Support
Navigating CDSCO licensing demands regulatory insight, attention to detail, and proactive communication. Our seasoned consultants provide end-to-end support—from gap analysis to document preparation, audit readiness, and query resolution—ensuring a smooth approval journey.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class C status using the Medical Device Classification resource.
- Prepare Documentation Early: Begin compiling Device and Plant Master Files alongside risk management documents.
- Schedule Testing: Contact CDSCO-approved labs to plan product testing timelines.
- Apply for Test License (MD13): Initiate testing with appropriate licensing.
- Utilize the CDSCO MD Online Portal: Submit applications through the official portal for streamlined processing.
Embarking on this regulatory journey with a clear roadmap and expert assistance significantly enhances your chance of timely approval, enabling you to bring your innovative implantable incontinence-control electrical stimulation system to Indian patients in need.
For personalized support and detailed guidance, connect with our regulatory experts today.
