CDSCO License for Ejaculation electrical stimulation system
Medical Device Information
Intended Use
Intended to apply electrical stimuli to the nerves that control ejaculation.
Comprehensive Guide to CDSCO Licensing for Ejaculation Electrical Stimulation System (Class C Medical Device)
Navigating the regulatory landscape for medical devices in India requires expertise, especially for specialized neurological devices like the Ejaculation Electrical Stimulation System. This device, intended to apply electrical stimuli to the nerves controlling ejaculation, falls under Risk Class C and demands rigorous compliance with the Central Drugs Standard Control Organization (CDSCO) regulations. With over 25 years of experience and having supported 500+ manufacturers and importers, we offer you a detailed roadmap to secure your CDSCO MD9 manufacturing license efficiently.
Understanding the CDSCO Regulatory Framework for Neurological Medical Devices
The Ejaculation Electrical Stimulation System is categorized under neurological devices and is classified as a Class C device as per the CDSCO guidelines. The CDSCO oversees the registration, manufacturing, and import licensing of such devices to ensure safety and efficacy before they enter the Indian market. The device is regulated under Notification 29/Misc/03/2020-DC (201), dated 27.09.2021, which specifically includes electrical stimulation systems.
Manufacturers and importers must comply with the Medical Device Rules, 2017, and follow the centralized approval process for Class C and D devices. The license required for manufacturing such devices is the MD9 license, issued by the Central Licensing Authority.
Risk Classification and License Requirements for Ejaculation Electrical Stimulation System
- Device Risk Class: Class C (Moderate to High Risk)
- Regulatory Pathway: MD9 Manufacturing License (Application Form MD7)
- Licensing Authority: Central Licensing Authority, CDSCO
Class C devices undergo a more stringent approval process than Class A and B devices due to their higher risk profile. This includes detailed product testing, documentation review, and a comprehensive audit by CDSCO officials.
Step-by-Step Manufacturing License Process (MD9) for Class C Devices
- Test License Application (Form MD13):
- Duration: Approximately 1.5 to 2 months
- Purpose: Allows limited manufacturing to generate samples for testing
- Product Testing:
- Conducted at CDSCO-approved laboratories to verify safety and performance
- You can refer to the list of government-approved testing laboratories
- Preparation of Regulatory Documents:
- Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, Quality Management System (QMS) documents
- Application Submission:
- Submit Form MD7 for MD9 license through the CDSCO MD Online Portal
- Audit & Inspection:
- CDSCO inspectors conduct an on-site audit to verify compliance with Good Manufacturing Practices (GMP)
- Query Resolution:
- Address any queries raised by the CDSCO or audit team promptly
- Grant of License:
- Issuance of MD9 license on Form MD9, authorizing manufacturing of the device
For an in-depth walkthrough, our detailed MD9 License Guide elaborates each step.
Essential Documents Required for MD9 License Application
- Company Constitution Documents: Registration certificates, Memorandum and Articles of Association
- Proof of Ownership/Lease of Manufacturing Premises
- Details of Qualified Technical Staff: Including their qualifications and experience
- Fire NOC and Pollution Control Certificate: From local authorities
- Device Master File (DMF): Detailed device design, manufacturing process, and testing protocols (Device Master File Guide)
- Plant Master File (PMF): Information about the manufacturing facility and quality control systems (Plant Master File Guide)
- Essential Principles Compliance Checklist: Demonstrating adherence to safety and performance requirements
- Risk Management File: Documenting risk analysis, evaluation, and mitigation strategies (Risk Management Guide)
- Test Reports: From CDSCO-approved laboratories
- Labels and Instructions for Use (IFU): Compliant with Indian regulatory standards
- Quality Management System Documents: ISO 13485:2016 certification and related SOPs
Ensuring accuracy and completeness in these documents significantly accelerates the approval timeline.
Import License Process (MD15) for Ejaculation Electrical Stimulation Systems
If you plan to import this device into India instead of manufacturing locally, you need to obtain an MD15 import license from CDSCO.
- Application Form: MD14
- Authority: Central Licensing Authority
- Processing Time: Approximately 5 to 6 months
- Key Documents Required:
- Valid manufacturing license from country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificate
- Device Master File and Plant Master File
- Wholesale license in India
- Company constitution documents
The Import License Guide provides a practical pathway for importers.
Timeline and Processing Duration for MD9 License
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| License Application (MD7) | Immediate via portal |
| Audit & Inspection | 1 month |
| Query Resolution & Approval | 2 - 3 weeks |
| Total Estimated Time | 4 to 5 months |
Planning ahead for these timelines can help you avoid costly delays.
Government Fees and Cost Structure for MD9 License
- Application Fee: ₹50,000 per application
- Per Product Fee: ₹1,000 per product
- Testing and Audit Costs: Variable, depending on product complexity and notified body fees
Payments are made online through the CDSCO MD Online Portal during application submission.
Common Challenges Faced and Practical Solutions
- Incomplete Documentation: Missing or inconsistent technical files often cause delays. We recommend thorough pre-submission audits.
- Delays in Product Testing: Coordinate early with CDSCO-approved labs and submit samples promptly.
- Audit Non-Compliance: Prepare your Quality Management System and manufacturing processes in line with ISO 13485 and CDSCO GMP to avoid non-conformities.
- Query Resolution Delays: Assign dedicated regulatory personnel to respond to CDSCO queries within stipulated timelines.
These pain points are common but manageable with expert guidance.
Expert Consultation and Regulatory Support
Our team has successfully guided over 500 companies through the CDSCO licensing maze. We offer tailored support including:
- Gap analysis of your current compliance status
- Documentation preparation and review
- Coordination with notified bodies and testing labs
- End-to-end application submission and follow-up
Engaging a seasoned regulatory partner reduces your risk and accelerates market entry.
Getting Started with Your CDSCO MD9 License Application
- Assess Your Device Classification: Confirm the Class C status using the Medical Device Classification resource.
- Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
- Coordinate Product Testing: Send your device samples to a vetted lab from the Testing Laboratories list.
- Compile Technical Documentation: Assemble your DMF, PMF, Risk Management File, and other essential documents.
- Schedule Pre-Audit Review: Conduct internal audits to ensure compliance with GMP and ISO standards.
- Submit MD9 Application (Form MD7): File online and prepare for the CDSCO inspection.
Starting early and following these actionable steps will streamline your regulatory journey for the Ejaculation Electrical Stimulation System.
For personalized assistance and to avoid common pitfalls, contact us today and leverage our 25+ years of regulatory expertise to successfully obtain your CDSCO license.
