CDSCO License for Deep-tissue electromagnetic stimulation system
Medical Device Information
Intended Use
Intended to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis); 2) treat body pain (musculoskeletal, postsurgical); and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of a therapeutic deep heat.
Comprehensive Guide to CDSCO Licensing for Deep-Tissue Electromagnetic Stimulation Systems (Class B)
As a trusted regulatory consultancy with over 25 years of experience and over 500 successful CDSCO licensing projects, we understand the complexities manufacturers and importers face while navigating India’s medical device regulations. This guide focuses on the Deep-tissue electromagnetic stimulation system, a Class B medical device designed for musculoskeletal treatment, pain relief, and tissue healing without generating therapeutic deep heat.
Understanding the Device and Its Regulatory Importance
The Deep-tissue electromagnetic stimulation system is categorized under rehabilitation devices and notified under File No. 29/Misc./03/2020-DC (160), dated 04.08.2022. Given its application in treating musculoskeletal disorders, pain, and aiding tissue healing, it falls under Class B risk classification as per CDSCO guidelines.
Regulatory compliance is crucial because it ensures the device meets safety, efficacy, and quality standards mandated by the Central Drugs Standard Control Organization (CDSCO). Without proper licensing, manufacturers cannot legally market or import this device in India.
CDSCO Regulatory Framework for Deep-Tissue Electromagnetic Stimulation Systems
The regulatory framework for medical devices in India follows the Medical Device Rules, 2017, implemented by CDSCO. Devices are classified from Class A (low risk) to Class D (high risk). For Class B devices like ours, the licensing authority is the State Licensing Authority, and the manufacturing license is issued in the form of an MD5 license.
The process involves multiple steps including test license acquisition, product testing, audit by notified bodies, document submission, and finally, license grant.
Risk Classification and License Requirements
- Device Class: B
- License Type: MD5 Manufacturing License (Form MD3 application)
- Licensing Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months total
- Fees: Rs 5,000 per application + Rs 500 per product
For this device, the MD5 license suffices for manufacturing. Importers, however, need to follow the MD15 license process.
Manufacturing License Process (MD5 License)
Apply for Test License (Form MD13): Before applying for MD5, you must obtain a test license allowing you to manufacture the device for testing purposes. This typically takes 1.5 to 2 months.
Product Testing: Conduct product testing at CDSCO-approved government or notified laboratories. For a deep-tissue electromagnetic stimulation system, testing includes safety, electromagnetic compatibility, and performance validation in line with applicable Indian and international standards. You can find a list of approved testing laboratories on the CDSCO portal.
Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), risk management file, quality management system (QMS) documents, labels, and instructions for use (IFU).
Audit by Notified Body: Engage an authorized notified body for a mandatory audit of your manufacturing facility and QMS. Refer to the list of notified bodies for selection.
Submit Application on CDSCO MD Online Portal: File the MD5 application (Form MD3) online with all required documents.
Respond to Queries: Address any queries or requests for additional information from CDSCO or the notified body.
License Grant: Upon satisfactory review, CDSCO issues the MD5 manufacturing license (Form MD5).
Manufacturing License Documents Required
- Company constitution documents (incorporation certificate, partnership deed, etc.)
- Proof of ownership or valid lease of manufacturing premises
- Qualification and experience certificates of technical staff
- Fire safety NOC from local authorities
- Pollution control board NOC
- Device Master File (DMF) detailing device design, manufacturing process, and performance
- Plant Master File (PMF) describing manufacturing facilities and equipment
- Essential Principles Checklist demonstrating conformity with Indian Medical Device Rules
- Risk Management File complying with ISO 14971 or equivalent
- Product test reports from approved labs
- Labels and IFU compliant with CDSCO requirements
- Quality Management System documentation (ISO 13485 certification recommended)
For detailed guidance on preparing DMF and PMF, review our Device Master File guide and Plant Master File guide.
Import License Process (MD15 License)
If you plan to import the Deep-tissue electromagnetic stimulation system into India, the MD15 import license applies.
- Authority: Central Licensing Authority (CDSCO, New Delhi)
- Processing Time: 5-6 months
- Fees: Varies by class; for Class B, approx Rs 2000 per site and Rs 1000 per product
The import license application requires submission of manufacturing license of the exporting country, Free Sale Certificate, ISO 13485:2016 certification, CE marking certificate if applicable, DMF, PMF, wholesale license, and company incorporation documents.
Full details and application forms are available on the CDSCO MD Online Portal.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate issued by the competent authority
- ISO 13485:2016 QMS certificate
- CE certificate or equivalent for product compliance
- Device Master File and Plant Master File
- Wholesale license for distribution in India
- Company constitution and registration certificates
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 2 to 3 weeks |
| Document Preparation | 2 to 4 weeks |
| Audit by Notified Body | 3 to 4 weeks |
| MD5 Application Review | 3 to 4 weeks |
| Query Resolution | 2 to 3 weeks |
| Total Duration | 3 to 4 months approx |
Manufacturers who proactively prepare documentation and coordinate testing efficiently often experience fewer delays.
Government Fees and Costs
- MD5 License Application Fee: Rs 5,000 per application
- Per Product Fee: Rs 500
- Test License Fee (MD13): Rs 5,000
- Notified Body Audit and Testing Charges: Varies; typically Rs 50,000 to Rs 1,00,000 depending on scope
Budgeting for notified body audits and product testing is critical. Early engagement with auditors and labs minimizes surprises.
Common Challenges and Solutions
Incomplete Documentation: Ensure all documents — especially DMF, PMF, and risk management files — are thorough and compliant. Our experts can review your files before submission.
Audit Non-Compliance: Prepare your manufacturing facility with mock audits. Common issues include inadequate QMS implementation or lack of technical expertise on site.
Delays in Product Testing: Plan testing timelines ahead and select CDSCO-approved laboratories with proven turnaround times.
Query Resolution Delays: Respond promptly and comprehensively to CDSCO queries to avoid prolonged approval times.
Expert Consultation and Support
Navigating the CDSCO licensing process can be complex, especially for innovative devices like deep-tissue electromagnetic stimulators. We provide end-to-end support including:
- Gap analysis of your current compliance status
- Preparation and review of Device and Plant Master Files
- Liaison with notified bodies and testing laboratories
- Application drafting and submission on the CDSCO MD Online Portal
- Handling queries and audit preparations
Our extensive experience ensures a smoother licensing journey and faster market entry.
Getting Started with Your CDSCO License Application
To get your Deep-tissue electromagnetic stimulation system licensed in India, follow these practical steps:
- Understand the Classification: Confirm Class B status and license type (MD5).
- Prepare Test License Application: Submit Form MD13 on the CDSCO portal to obtain permission for product testing.
- Select Testing Laboratory: Choose a CDSCO-approved lab from the Testing Laboratories list.
- Compile Documentation: Gather all required documents including DMF, PMF, risk management file, and QMS certificates.
- Schedule Notified Body Audit: Contact a notified body early; audit reports are mandatory for license submission.
- File MD5 Application: Submit Form MD3 with all attachments on the CDSCO MD Online Portal.
- Prepare for Queries: Assign a regulatory lead to respond quickly to any CDSCO or notified body requests.
Starting early with a clear roadmap is essential to meet the 3-4 month timeline efficiently. Reach out to our expert team to schedule a consultation and ensure your application is flawless from day one.
For detailed insights on the MD5 license process specifically for Class A/B devices, consult our MD5 License Guide.
By adhering to the outlined process and leveraging professional support, manufacturers and importers of Deep-tissue electromagnetic stimulation systems can confidently navigate CDSCO licensing, ensuring timely compliance and successful entry into the Indian medical device market.
