CDSCO License for Analgesic TENS system
Medical Device Information
Intended Use
Intended to treat pain by transcutaneous electrical simulation on peripheral nerves.
Comprehensive Guide to CDSCO Licensing for Analgesic TENS System (Class B Medical Device)
As a company with over 25 years of expertise in medical device regulatory affairs, we have supported 500+ manufacturers and importers in navigating the complex CDSCO licensing landscape in India. Today, we provide an in-depth, practical guide specifically tailored for Analgesic TENS systems, a Class B neurological medical device intended for pain treatment via transcutaneous electrical stimulation.
Understanding the Device and Its Regulatory Importance
The Analgesic TENS (Transcutaneous Electrical Nerve Stimulation) system is designed to alleviate pain by delivering electrical impulses through peripheral nerves. Classified as a Class B device under the Indian medical device rules, it requires stringent regulatory compliance to ensure safety and efficacy before market entry. Proper CDSCO licensing is mandatory to legally manufacture or import this device in India.
CDSCO Regulatory Framework for Analgesic TENS Systems
The Central Drugs Standard Control Organisation (CDSCO) governs medical device regulation under the Ministry of Health and Family Welfare. For Class B devices like the Analgesic TENS system, the manufacturing license is issued by the State Licensing Authority via the MD5 License (Form MD3 application) process. This framework includes product testing, documentation, audits, and compliance with essential principles.
Risk Classification and License Requirements
Our device falls under Class B, which is considered low moderate risk. Here’s what that means for your licensing:
- License Type: MD5 Manufacturing License
- Authority: State Licensing Authority
- Application Form: MD3
- Total Processing Time: Approximately 3-4 months
- Fees: Rs. 5,000 per application + Rs. 500 per product
For more on device classification, refer to our detailed Medical Device Classification guide.
Manufacturing License Process (MD5 License)
The MD5 licensing process is multi-step and requires meticulous preparation:
- Test License (Form MD13): Apply for a test license, which takes about 1.5 to 2 months. This allows sample testing of your device.
- Product Testing: Get the Analgesic TENS system tested at a government-approved laboratory to verify compliance with safety and performance standards. Access the list of testing laboratories for your region.
- Documentation Preparation: Compile comprehensive documents including Device Master File (DMF), Plant Master File (PMF), risk management, labeling, and quality management system records.
- License Application: Submit your MD5 license application (Form MD3) through the CDSCO MD Online Portal.
- Audit: A notified body will conduct a thorough audit of your manufacturing facility and quality systems. Select your notified body from the official list.
- Resolution of Queries: Address any observations or queries raised by CDSCO or the notified body promptly.
- License Grant: Upon successful audit and compliance, the license is issued on Form MD5.
Manufacturing License Documents Required
Proper documentation is key to a smooth licensing process. Here’s what you need for your Analgesic TENS system:
- Company Constitution/Registration Documents
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire Safety NOC
- Pollution Control NOC
- Device Master File (DMF): Detailed device design, specifications, manufacturing process (DMF guide)
- Plant Master File (PMF): Manufacturing site details and quality control procedures (PMF guide)
- Essential Principles Checklist (compliance with Indian medical device rules)
- Risk Management File (hazard analysis, risk mitigation plans) (Risk Management insights)
- Test Reports from recognized laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (ISO 13485 certification recommended)
Import License Process (MD15 License) for Analgesic TENS Systems
If you are importing the Analgesic TENS device, you need an MD15 import license issued by the Central Licensing Authority:
- Application Form: MD14
- Process Duration: Approximately 5-6 months
- Documents Required: Manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), DMF and PMF, wholesale license, and company constitution.
- Fees: Vary by class; for Class B devices, typically Rs. 2000 per site + Rs. 1000 per product.
Submit your import license application via the CDSCO MD Online Portal.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Documentation & Application | 2 - 3 weeks |
| Audit & Query Resolution | 3 - 4 weeks |
| Total | 3 - 4 months |
Early preparation of documents and prompt response to queries can significantly reduce delays.
Government Fees and Costs
- MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
- Test License (MD13): Included in the application process
- Notified Body Audit Fees: Varies; typically Rs. 50,000 to Rs. 1,00,000 depending on scope
- Testing Fees: Depends on laboratory rates; budget approx Rs. 50,000 - Rs. 1,00,000
Common Challenges and Solutions
1. Incomplete Documentation: Many manufacturers face delays due to missing or inconsistent documents. We recommend using detailed checklists and consulting expert guides such as our MD5 License Guide.
2. Delayed Testing Results: Plan well in advance and select government-approved labs early. Maintain communication with labs to expedite sample testing.
3. Audit Non-compliance: Ensure your manufacturing facility and QMS meet CDSCO standards before audit. Pre-audit assessments by consultants can be invaluable.
4. Query Resolution Delays: Assign a dedicated regulatory liaison to respond swiftly to CDSCO and notified body queries.
Expert Consultation and Support
With decades of experience, we help you:
- Prepare and review regulatory documents
- Liaise with CDSCO and notified bodies
- Coordinate product testing at accredited labs
- Conduct pre-audit readiness assessments
- Manage timelines and fees efficiently
Our support has helped 500+ companies successfully launch devices like the Analgesic TENS system in India.
Getting Started with Your CDSCO License Application
To initiate your licensing journey:
- Register your company and manufacturing site on the CDSCO MD Online Portal.
- Collect and prepare all required documents listed above.
- Apply for the test license (Form MD13) immediately to avoid bottlenecks.
- Identify a notified body from the official list and establish contact.
- Schedule product testing at an approved laboratory.
- Engage experienced regulatory consultants to guide you through audit and submission.
By following these actionable steps and leveraging expert assistance, you can streamline the MD5 licensing process for your Analgesic TENS system and confidently enter the Indian market.
We are committed to helping you achieve CDSCO compliance efficiently and successfully. Contact us today to discuss your specific needs and start your regulatory journey with confidence.
