CDSCO License for Epicranial brain electrical stimulation system
Medical Device Information
Intended Use
Intended to apply weak, pulsed (not continuous) electrical stimuli from beneath the scalp to specific areas of the brain for the treatment of focal epilepsy.
Comprehensive Guide to CDSCO Licensing for Epicranial Brain Electrical Stimulation System (Class C)
Navigating the regulatory landscape for advanced neurological devices like the Epicranial Brain Electrical Stimulation System requires in-depth knowledge and experience. This device, designed to deliver weak, pulsed electrical stimuli beneath the scalp for treating focal epilepsy, falls under Class C risk classification according to CDSCO guidelines. As a trusted regulatory consultancy with over 25 years of experience and having successfully assisted 500+ companies in obtaining CDSCO licenses, we provide a detailed roadmap to help manufacturers and importers bring this innovative device to the Indian market efficiently and compliantly.
Understanding the CDSCO Regulatory Framework for Neurological Medical Devices
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. The Epicranial Brain Electrical Stimulation System, categorized under neurological devices and notified under Notification 29/Misc/03/2020-DC (201) dated 27.09.2021, is classified as a Class C device due to its medium to high risk profile.
Regulatory compliance is mandatory to ensure patient safety and product efficacy. The CDSCO framework mandates that Class C devices undergo a rigorous approval process managed by the Central Licensing Authority, involving product testing, documentation, and audits.
Risk Classification and Licensing Requirements for Class C Devices
Class C devices represent moderate to high risk. The Epicranial Brain Electrical Stimulation System qualifies under this category, requiring an MD9 manufacturing license for domestic production or MD15 import license for foreign manufacturers/distributors.
- MD9 License: For manufacturing Class C devices within India, issued by the Central Licensing Authority.
- MD15 License: For importing Class C devices into India.
This guide primarily focuses on the MD9 manufacturing license process.
Detailed Manufacturing License Process for Epicranial Brain Electrical Stimulation System (MD9 License)
Obtaining an MD9 license involves several critical steps, with a typical timeline of 4 to 5 months:
- Test License Application (Form MD13): Initiate by applying for a test license which typically takes 1.5 to 2 months. This license allows product testing at CDSCO-recognized labs.
- Product Testing: Conduct comprehensive testing of the device at government-approved laboratories to validate safety and performance.
- Document Preparation: Assemble all required documentation including technical, quality, and safety files.
- License Application Submission (Form MD7): Submit the MD9 license application through the CDSCO MD Online Portal.
- Inspection and Audit: CDSCO inspectors will conduct on-site audits to verify compliance with QMS and manufacturing standards.
- Query Resolution: Address any queries raised by the CDSCO inspectors or the licensing authority promptly.
- License Grant (Form MD9): Upon satisfactory review, the MD9 license is granted.
Essential Documents Required for MD9 License Application
For the Epicranial Brain Electrical Stimulation System, the following documents must be meticulously prepared:
- Company Constitution documents
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of the technical staff
- Fire and pollution no-objection certificates (NOCs)
- Device Master File (DMF) detailing design, specifications, and intended use (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing facility and processes (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File, highlighting risk assessment and mitigation strategies (Risk Management)
- Product Test Reports from CDSCO-approved testing labs (Testing Laboratories)
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified
Import License Process for Epicranial Brain Electrical Stimulation System (MD15 License)
For importers, the MD15 license application process is managed centrally and generally takes 5 to 6 months. Unlike manufacturing, no test license is required. The steps include:
- Preparing comprehensive documentation including manufacturing license from the country of origin, Free Sale Certificate, ISO certifications, CE marking, DMF and PMF, wholesale license, and company constitution.
- Submitting the application on the CDSCO MD Online Portal.
- Responding to any regulatory queries.
- Receiving the import license (Form MD15).
Timeline and Processing Duration Breakdown
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 2 - 3 weeks |
| License Application & Audit | 1.5 - 2 months |
| Query Resolution and Final Grant | 2 - 3 weeks |
| Total Time for MD9 License | 4 - 5 months |
Government Fees and Cost Structure
The MD9 license fees applicable to Class C devices like the Epicranial Brain Electrical Stimulation System are as follows:
- Application Fee: INR 50,000 per application
- Product Fee: INR 1,000 per product
Additional costs include testing fees charged by approved laboratories (varies by test scope) and audit fees if outsourced to notified bodies.
Common Challenges and Practical Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage early with CDSCO-approved testing labs and schedule testing slots promptly. Utilize the Testing Laboratories list to select labs with shorter turnaround times.
Challenge 2: Incomplete Documentation
- Solution: Rely on expert guidance for preparing comprehensive Device and Plant Master Files, risk management files, and QMS documentation.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal pre-audit checks and refer to the Notified Bodies List for selecting experienced auditors.
Expert Consultation and Regulatory Support
Our consultancy has empowered over 500 medical device companies in India to navigate the CDSCO licensing process seamlessly. We offer tailored support including:
- Gap analysis of existing documentation
- Preparation of Device and Plant Master Files
- Coordination with testing labs and notified bodies
- End-to-end application submission and query management
Getting Started with Your CDSCO License Application for the Epicranial Brain Electrical Stimulation System
- Assess Product Classification: Confirm Class C risk classification using the Medical Device Classification Guide.
- Initiate Test License (MD13) Application: Submit your application via the CDSCO MD Online Portal to start the testing process.
- Engage Testing Laboratories: Schedule product testing at CDSCO-approved labs.
- Prepare Documentation: Compile all required documents including DMF, PMF, risk management files, and QMS.
- Submit MD9 License Application (Form MD7): Once testing is complete, apply for the manufacturing license.
- Arrange for CDSCO Audit: Coordinate with CDSCO inspectors or notified bodies to schedule the inspection.
- Respond to Queries: Maintain prompt communication and resolve any regulatory questions.
- Obtain License and Begin Manufacturing: Upon license grant, you can commence compliant manufacturing of your device in India.
Our experienced team is ready to assist you every step of the way to ensure a smooth and timely approval process. Contact us to leverage our proven expertise and bring your Epicranial Brain Electrical Stimulation System to the Indian market with confidence.
