CDSCO License for Arthritis TENS system
Medical Device Information
Intended Use
Intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneous).
Comprehensive Guide to CDSCO Licensing for Arthritis TENS System (Class B Medical Device)
As specialists with over 25 years of experience in assisting 500+ manufacturers and importers, we understand the unique regulatory pathways for medical devices like the Arthritis TENS system. This device, classified as Class B under CDSCO regulations, plays a crucial role in rehabilitation by providing adjunctive therapy to reduce pain and stiffness in rheumatoid arthritis and osteoarthritis through transcutaneous electrical nerve stimulation.
Understanding the CDSCO Regulatory Framework for Arthritis TENS System
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Ministry of Health and Family Welfare, India. The Arthritis TENS system falls under the rehabilitation device category and is notified under File No. 29/Misc./03/2020-DC (160) dated 04.08.2022.
Being a Class B device (low to moderate risk), it requires a manufacturing license known as the MD5 license, issued by the State Licensing Authority. The regulatory framework emphasizes product safety, efficacy, and quality management to protect patient health.
Risk Classification and License Requirements
- Device Risk Class: B (Low to moderate risk)
- License Type: MD5 Manufacturing License (Application Form MD3)
- Issuing Authority: State Licensing Authority
- Processing Time: Approximately 3-4 months (including test license and audit)
Class B devices like the Arthritis TENS system require a thorough compliance process, including product testing in government-approved laboratories and factory audits by notified bodies.
Manufacturing License Process (MD5) for Arthritis TENS System
Test License Application (Form MD13): Before the manufacturing license, manufacturers must obtain a Test License. This initial step takes roughly 1.5 to 2 months and allows the device to be tested.
Product Testing: Testing must be completed at CDSCO-approved labs to validate safety and performance. You can find the list of approved Testing Laboratories on the CDSCO portal.
Document Preparation: Prepare all necessary documentation, including Device Master File, Plant Master File, Risk Management File, and QMS documents.
License Application Submission (Form MD3): Submit the MD5 application through the CDSCO MD Online Portal.
Factory Audit: A notified body conducts an on-site audit to verify compliance with Good Manufacturing Practices (GMP) and quality systems. Check the list of notified bodies for audit requirements.
Query Resolution: Address any queries from CDSCO or the notified body promptly to avoid delays.
License Grant (Form MD5): Upon successful audit and document review, the manufacturing license is granted.
Manufacturing License Documents Required
For the Arthritis TENS system, ensure you have the following documents ready:
- Company Constitution Documents (e.g., Memorandum and Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire Safety NOC
- Pollution Control Board NOC
- Device Master File (DMF) detailing design and manufacturing processes (our Device Master File guide can assist)
- Plant Master File (PMF) outlining facility details (Guide to Plant Master File)
- Risk Management File complying with ISO 14971 (Implement Medical Device Risk Management)
- Essential Principles Checklist demonstrating conformity
- Product Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485 certification)
Import License Process (MD15) for Arthritis TENS System
If you are an importer, the MD15 license is mandatory. This license is issued by the Central Licensing Authority and requires a longer processing time of approximately 5-6 months.
Steps include:
- Document preparation (including Manufacturing License, Free Sale Certificate, CE Certificate, ISO 13485:2016)
- Submission of application on the CDSCO MD Online Portal
- Query resolution
- License grant
Refer to our detailed Import License Guide for step-by-step assistance.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Timeframe |
|---|---|
| Test License (Form MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | Concurrent with testing |
| MD5 License Application (MD3) | 1 to 1.5 months |
| Factory Audit & Query Resolution | 1 month |
| Total | 3 to 4 months |
This timeline assumes proactive query resolution and complete documentation.
Government Fees and Costs
For the Arthritis TENS system (Class B):
- Test License Fee (MD13): Included in application
- MD5 License Application Fee: ₹5,000 per application
- Product-wise Fee: ₹500 per product
- Audit and Testing Fees: Varies based on notified body and testing lab charges
Budgeting for these fees early in your project planning can prevent unexpected delays.
Common Challenges and Practical Solutions
Challenge: Delays due to incomplete documentation or inadequate risk management files.
Solution: Utilize professional templates and checklists for Device and Plant Master Files. Our Device Master File guide offers practical examples.
Challenge: Prolonged product testing due to lab backlogs.
Solution: Engage with CDSCO-approved labs early and schedule testing promptly. Refer to the Testing Laboratories list.
Challenge: Audit non-conformities during GMP inspection.
Solution: Conduct internal pre-audits and implement robust QMS aligned with ISO 13485 standards.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for Class B devices like the Arthritis TENS system. Our team’s extensive experience ensures:
- Tailored guidance for documentation and compliance
- Liaison with notified bodies and CDSCO officials
- Efficient query management and audit readiness
We have successfully facilitated licensing for numerous rehabilitation devices, ensuring market entry without regulatory hurdles.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm the Arthritis TENS system as Class B.
- Prepare Test License Application (MD13): Gather preliminary documents.
- Identify Approved Testing Labs: Schedule product testing early.
- Compile Device and Plant Master Files: Use expert guides to ensure completeness.
- Register and Apply via CDSCO MD Online Portal: Submit applications and track progress.
- Plan for Factory Audit: Coordinate with notified bodies listed here.
- Engage Expert Consultants: To streamline the process and avoid common pitfalls.
Embarking on your CDSCO licensing journey with thorough preparation will set the foundation for successful market authorization of your Arthritis TENS system, enabling you to contribute meaningfully to patient care in India.
For personalized assistance and to initiate your application process, contact our regulatory experts today.
