CDSCO License for Scoliosis- treatment electrical stimulation system
Medical Device Information
Intended Use
Intended to apply electrical stimuli to the spinal musculature to produce a force that stabilizes or limits the progression of the spinal lateral curvature (i.e., scoliosis).
Introduction: Understanding the Scoliosis Treatment Electrical Stimulation System and Its Regulatory Importance
The Scoliosis Treatment Electrical Stimulation System is a high-risk Class D neurological medical device designed to apply electrical stimuli to spinal musculature. Its purpose is to stabilize or limit the progression of spinal lateral curvature in scoliosis patients, making it a critical therapeutic tool. Given its impact on patient safety and efficacy, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or importing this device into India.
Navigating the CDSCO licensing process for such a high-risk device requires careful planning, detailed documentation, and adherence to stringent quality standards. With over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we provide comprehensive guidance tailored specifically for the Scoliosis Electrical Stimulation System under Risk Class D.
CDSCO Regulatory Framework for Neurological Class D Devices
The CDSCO regulates medical devices in India under the Medical Device Rules (MDR) 2017, classifying devices into four risk classes—A, B, C, and D—based on their potential risk. As a Class D device, the Scoliosis Electrical Stimulation System falls into the highest risk category, necessitating approval from the Central Licensing Authority.
The device is notified under number 29/Misc/03/2020-DC (201) dated 27.09.2021. For Class D devices, the manufacturing license is obtained via the MD9 form (Application Form MD7), while importers require the MD15 license.
Risk Classification and License Requirements for the Device
- Device Name: Scoliosis Treatment Electrical Stimulation System
- Risk Class: D (Highest Risk)
- Category: Neurological
- License Type: MD9 Manufacturing License (Central Licensing Authority)
- Import License: MD15 (Central Licensing Authority)
Because the device applies electrical stimulation directly affecting spinal muscles, the regulatory burden includes rigorous safety, efficacy, and quality management system (QMS) compliance.
Manufacturing License Process (MD9) for Class D Devices
The MD9 license application process is comprehensive and involves several critical steps:
Test License (Form MD13): Initially, manufacturers must obtain a test license which takes approximately 1.5 to 2 months. This permits limited manufacturing for testing purposes.
Product Testing: Testing must be conducted at CDSCO-approved labs to validate safety and performance. You can find the list of approved testing laboratories on the CDSCO portal.
Document Preparation: Compile technical documentation including the Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.
License Application (Form MD7): Submit the MD9 application through the CDSCO MD Online Portal.
Audit and Inspection: CDSCO inspectors conduct facility audits and QMS assessments.
Query Resolution: Address any clarifications or deficiencies raised during audit or review.
Grant of License (Form MD9): Upon satisfactory compliance, the manufacturing license is granted.
The entire process typically takes 4 to 5 months.
Manufacturing License Documents Required for MD9
Successful applications require meticulous documentation. For the Scoliosis Electrical Stimulation System, ensure you have:
- Company constitution and registration proof
- Proof of ownership or lease agreement of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board NOC
- Comprehensive Device Master File (refer to our Device Master File Guide)
- Plant Master File (Guide here)
- Essential Principles Compliance Checklist
- Risk Management File following ISO 14971 standards (Risk Management Insights)
- Test reports from CDSCO-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System documentation aligned with ISO 13485
Ensuring these documents are complete and accurate significantly reduces review times and audit queries.
Import License Process (MD15) for the Device
If you plan to import the Scoliosis Electrical Stimulation System, the MD15 license is mandatory. The process steps are:
Document Preparation: Gather necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device and Plant Master Files, wholesale license, and company constitution.
Application Submission: File the MD15 application using Form MD14 via the CDSCO MD Online Portal.
Review and Query Resolution: CDSCO reviews the application and may request additional information.
License Grant: Upon approval, the import license is issued.
The process generally takes 5 to 6 months.
Import License Documents Required for MD15
Key documents for import license include:
- Valid manufacturing license from the country of origin
- Free Sale Certificate demonstrating market authorization
- ISO 13485:2016 and CE Certificates
- Device Master File and Plant Master File
- Wholesale License for import and distribution
- Company Constitution and registration certificates
- Product labels and IFU
Maintaining consistency in documentation across manufacturing and import processes helps streamline regulatory approvals.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 3 – 4 weeks |
| Application Submission & Review | 1 month |
| Audit & Inspection | 2 – 3 weeks |
| Query Resolution & License Grant | 2 – 3 weeks |
Overall Manufacturing License (MD9): 4–5 months
Import License (MD15): 5–6 months
Government Fees and Costs
MD9 Manufacturing License:
- Application fee: ₹50,000
- Fee per product: ₹1,000
MD15 Import License:
- Site fee: ₹2,25,000 (~$3000) for Class D
- Product fee: ₹1,12,500 (~$1500) per product
Additional costs may include testing fees at CDSCO-approved laboratories and audit fees charged by notified bodies.
Common Challenges and Solutions
Challenge 1: Document Incompleteness and Non-compliance
- Solution: Engage expert consultants early to prepare Device and Plant Master Files and risk management documentation. We recommend referring to our detailed MD9 License Guide for best practices.
Challenge 2: Delays in Product Testing
- Solution: Coordinate with CDSCO-approved labs well in advance. Prioritize scheduling and sample preparation.
Challenge 3: Audit Non-conformities
- Solution: Conduct internal audits and pre-assessment using notified bodies listed on the CDSCO Notified Bodies List.
Challenge 4: Query Resolution Delays
- Solution: Maintain a dedicated regulatory affairs team or consultant to respond promptly to CDSCO queries.
Expert Consultation and Support
Our extensive experience with 500+ companies navigating regulatory pathways ensures you benefit from:
- Customized regulatory strategy for your Class D neurological device
- Preparation and review of technical documentation
- Coordination with CDSCO and notified bodies
- End-to-end project management for licensing process
Partnering with seasoned professionals mitigates risks and accelerates market entry.
Getting Started with Your CDSCO License Application
Assess Risk Classification: Confirm your device as Class D using CDSCO classification tools (Medical Device Classification).
Prepare Key Documentation: Start with detailed Device and Plant Master Files, risk management plans, and QMS documents.
Apply for Test License (MD13): Submit your initial test license application via the CDSCO MD Online Portal.
Schedule Product Testing: Arrange testing at CDSCO-approved labs once the test license is granted.
Compile and Submit MD9 Application: After successful testing, prepare and file your manufacturing license application.
Prepare for Audit: Conduct internal audits and rectify any gaps before the CDSCO inspection.
Respond to Queries Promptly: Ensure timely communication to prevent delays.
By following these practical steps and leveraging expert support, manufacturers and importers can confidently navigate the CDSCO licensing process for the Scoliosis Treatment Electrical Stimulation System.
For detailed assistance and tailored consulting services, feel free to contact our regulatory experts who have a proven track record of successful approvals in this domain.
