CDSCO License for Short-wave diathermy treatment system
Medical Device Information
Intended Use
Intended to provide a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio- frequency (RF) bands of 13 MHz to 27.12 MHz
Comprehensive Guide to CDSCO Licensing for Short-wave Diathermy Treatment Systems (Class C Medical Devices)
Short-wave diathermy treatment systems play a vital role in rehabilitation by delivering therapeutic deep heat through transcutaneous transmission of electromagnetic energy in the 13 MHz to 27.12 MHz RF band. Given their therapeutic application and electromagnetic nature, these devices are classified as Class C medical devices under the Indian regulatory framework. Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process for these devices requires detailed understanding of regulatory requirements, timelines, documentation, and compliance standards.
With over 25 years of experience assisting 500+ manufacturers and importers, we offer you an authoritative, step-by-step roadmap to successfully obtain your CDSCO license for short-wave diathermy systems.
CDSCO Regulatory Framework for Short-wave Diathermy Treatment Systems
The CDSCO governs the import, manufacture, and sale of medical devices in India. Your device, categorized under rehabilitation devices, falls under the Class C risk category due to its therapeutic effects and electromagnetic exposure.
The regulatory framework mandates compliance with the Medical Device Rules 2017, requiring manufacturers and importers to secure appropriate licenses before marketing.
For Class C devices like the short-wave diathermy system, the Central Licensing Authority issues the manufacturing license known as the MD9 license (Application Form MD7). Importers require the MD15 license.
Refer to the official Medical Device Classification guide for detailed categorization criteria.
Risk Classification and License Requirements
- Risk Class: C (higher medium risk)
- License Type: MD9 Manufacturing License (Form MD7)
- Issuing Authority: Central Licensing Authority, CDSCO
- Typical processing duration: 4-5 months
The device’s electromagnetic energy emission and therapeutic nature elevate it to Class C, necessitating stringent compliance and regulatory scrutiny.
Manufacturing License Process (MD9) for Short-wave Diathermy Systems
The MD9 license process is comprehensive and includes the following sequential steps:
Test License Acquisition (MD13 Form): Before full license submission, manufacturers must obtain a test license for product testing. This typically takes 1.5-2 months.
Product Testing: The short-wave diathermy device must undergo testing at CDSCO-approved labs to verify compliance with applicable standards (like IEC 60601-2-3 for therapeutic devices).
Documentation Preparation: Detailed technical and quality documentation must be prepared, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
License Application Submission (MD7 Form): Submit the manufacturing license application through the CDSCO MD Online Portal.
Inspection and Audit: CDSCO inspectors will audit your manufacturing site and documentation to ensure compliance.
Query Resolution: Address any queries or deficiencies raised by the CDSCO during the review.
Grant of License: Upon successful completion, the MD9 license will be issued.
For a detailed understanding, consult our MD9 License Guide.
Manufacturing License Documents Required
The following documents are mandatory for the MD9 license application:
- Company Constitution documents (Incorporation Certificate, MOA/AOA)
- Proof of ownership/lease agreement of manufacturing premises
- Qualification documents of technical staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing device specifications, design, and performance
- Plant Master File (PMF) outlining manufacturing processes and quality systems
- Essential Principles Checklist demonstrating conformity with regulatory requirements
- Risk Management File covering hazard identification and mitigation strategies
- Test reports from CDSCO-approved laboratories
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification
You can refer to our comprehensive Device Master File guide and Plant Master File guide for detailed document preparation.
Import License Process (MD15) for Short-wave Diathermy Systems
If you plan to import short-wave diathermy systems into India, you must obtain an MD15 import license issued by CDSCO’s Central Licensing Authority.
Key steps include:
Preparation of required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate (if applicable), DMF, PMF, Wholesale License, and Company Constitution.
Application submission on the CDSCO MD Online Portal.
Resolution of any queries raised.
Grant of MD15 import license.
The typical processing duration for import licenses is 5-6 months.
Our Import License Guide offers a detailed walkthrough.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution documents
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| License Application Review | 1 - 1.5 months |
| Inspection and Audit | 2 - 3 weeks |
| Query Resolution | 2 - 4 weeks |
| Total Duration (MD9) | 4 - 5 months |
Manufacturers should plan for a total timeline of approximately 4-5 months from test license to full manufacturing license grant.
Government Fees and Costs
| Fee Type | Amount (INR) |
|---|---|
| MD9 Application Fee | ₹50,000 |
| Per Product Fee | ₹1,000 per product |
Additional costs include testing fees charged by government-approved laboratories and notified body audit fees.
Common Challenges and Solutions
Challenge 1: Delays due to incomplete documentation or non-compliance.
- Solution: Meticulous document preparation using checklists and expert review ensures completeness.
Challenge 2: Testing failures or inadequate test reports.
- Solution: Engage accredited testing laboratories early. Refer to the list of testing laboratories to choose CDSCO-approved labs.
Challenge 3: Audit non-conformities during inspection.
- Solution: Conduct internal audits and mock inspections to prepare for CDSCO audits.
Challenge 4: Lengthy query resolution process.
- Solution: Respond promptly and comprehensively to queries, supported by accurate documentation.
Expert Consultation and Support
Our regulatory consultancy has successfully supported over 500 companies in obtaining MD9 licenses for Class C devices, including rehabilitation equipment like short-wave diathermy systems. We provide:
- End-to-end application preparation
- Device and plant master file drafting
- Risk management and essential principles compliance
- Coordination with notified bodies and testing labs
- Audit readiness and query handling
Leverage our expertise to avoid common pitfalls and expedite your market entry.
Getting Started with Your CDSCO License Application
Evaluate your device classification: Confirm your device’s Class C status using the Medical Device Classification tool.
Initiate test license application: Submit Form MD13 via the CDSCO MD Online Portal to begin product testing.
Engage a notified body for audit preparation: Check the list of notified bodies and select a suitable auditor.
Prepare all requisite documentation: Utilize our guides for Device Master File and Plant Master File.
Schedule product testing: Coordinate with CDSCO-approved labs early to account for testing turnaround times.
Submit manufacturing license application (Form MD7): After successful testing and documentation, file your MD9 application online.
Prepare for inspection: Conduct internal audits and ensure your QMS aligns with ISO 13485 standards.
Respond promptly to queries: Maintain open communication with CDSCO to resolve any concerns.
By following these practical steps and partnering with experienced regulatory consultants, your short-wave diathermy treatment system can achieve timely CDSCO approval, paving the way for successful marketing in India’s dynamic healthcare sector.
