CDSCO License for Musculoskeletal infrared phototherapy unit,
Medical Device Information
Intended Use
Intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing.

Introduction: Understanding Musculoskeletal Infrared Phototherapy Units and Regulatory Importance
Musculoskeletal infrared phototherapy units are specialized medical devices designed to emit infrared heat for localized treatment of musculoskeletal conditions such as muscle pain, sports injuries, and rheumatism. By improving blood circulation in targeted areas, these devices facilitate faster healing and pain relief. Given their therapeutic application and patient interaction, regulatory compliance is crucial to ensure safety and efficacy.
As a rehabilitation category device classified as Class B under CDSCO regulations, manufacturers and importers must obtain the appropriate licenses before marketing these units in India. With over 25 years of experience assisting 500+ companies in securing CDSCO approvals, we understand the complexities involved and offer practical, step-by-step guidance tailored to this device.
CDSCO Regulatory Framework for Musculoskeletal Infrared Phototherapy Units
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulations in India. Devices like musculoskeletal infrared phototherapy units fall under the rehabilitation category and are classified as Class B devices according to the CDSCO risk classification system. This classification mandates compliance with specific manufacturing and import licensing protocols.
Manufacturers must secure an MD5 license from the State Licensing Authority, while importers require an MD15 import license from the Central Licensing Authority. Both licenses ensure adherence to quality standards, safety norms, and proper documentation.
Risk Classification and License Requirements for Class B Devices
Per CDSCO's classification, Class B devices are considered low to moderate risk. This classification determines licensing requirements:
- Manufacturing License: MD5 License (Application Form MD3) granted by State Licensing Authority
- Import License: MD15 License (Application Form MD14) granted by Central Licensing Authority
For musculoskeletal infrared phototherapy units, the MD5 license is mandatory for domestic manufacturing, involving a multi-stage process including test licensing, product testing, and audits.
Manufacturing License Process (MD5) for Musculoskeletal Infrared Phototherapy Units
The MD5 license process involves several key stages:
Test License (Form MD13): Initially, manufacturers apply for a test license allowing limited production to facilitate product testing. This stage typically takes 1.5 to 2 months.
Product Testing: The devices must be tested at government-approved labs to verify compliance with applicable standards. You can find the list of testing laboratories recognized by CDSCO.
Document Preparation: Prepare comprehensive documentation, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will conduct a compliance audit. Refer to the list of notified bodies authorized for Class B devices.
Resolution of Queries: Address any queries raised by CDSCO or the notified body promptly.
Grant of License (Form MD5): Upon successful completion, the manufacturing license is granted.
The entire process for Class B devices generally takes 3 to 4 months.
Manufacturing License Documents Required for Musculoskeletal Infrared Phototherapy Units
Accurate and complete documentation is critical. For MD5 licensing, prepare the following:
- Company Constitution (e.g., Memorandum & Articles of Association)
- Proof of ownership or valid lease of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing process. Our Device Master File guide offers detailed insights.
- Plant Master File (PMF), outlining the manufacturing facility and quality controls (Plant Master File Guide)
- Essential Principles Checklist ensuring compliance with Indian Medical Device Rules
- Risk Management File documenting hazard analysis and mitigation strategies (Risk Management)
- Test Reports from government-approved laboratories
- Product labels and Instructions for Use (IFU)
- Quality Management System certificates (e.g., ISO 13485:2016)
Import License Process (MD15) for Musculoskeletal Infrared Phototherapy Units
For importers, obtaining an MD15 license is mandatory before marketing musculoskeletal infrared phototherapy units in India. The process includes:
Document Preparation: Compile documents such as valid manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.
Application Submission: Submit Form MD14 application through the CDSCO MD Online Portal.
Query Resolution: Respond to any clarifications or requests from CDSCO.
Grant of License: After satisfactory review, CDSCO issues the MD15 license.
The MD15 license process typically takes 5 to 6 months. Notably, no test license is required for imports.
Import License Documents Required for Musculoskeletal Infrared Phototherapy Units
Essential documents include:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
License Type | Processing Time |
---|---|
MD5 Manufacturing | 3 to 4 months |
Test License (MD13) | 1.5 to 2 months |
MD15 Import License | 5 to 6 months |
Manufacturers should plan ahead to accommodate testing, audits, and potential query resolution. Early preparation of documents significantly reduces delays.
Government Fees and Costs for Musculoskeletal Infrared Phototherapy Units
MD5 License:
- Application Fee: ₹5,000
- Per Product Fee: ₹500
Test License (MD13): Generally included within the process cost but may involve separate nominal fees.
MD15 Import License:
- Site Fee: $1,000 (approx. ₹75,000)
- Per Product Fee: $50 (approx. ₹3,750)
Costs may vary slightly due to exchange rates and additional service fees.
Common Challenges and Solutions
Incomplete Documentation: Missing or inconsistent files cause delays. Using standardized templates for Device Master Files and Plant Master Files can streamline submissions.
Audit Non-compliance: Non-adherence to Good Manufacturing Practices (GMP) can result in audit failure. Conduct internal mock audits before the official inspection.
Testing Delays: Scheduling tests at government-approved labs can be time-consuming. Early booking and coordination with testing laboratories are advisable.
Query Management: Delayed responses to CDSCO queries prolong approvals. Assign dedicated personnel for timely communication.
Expert Consultation and Support
Navigating the CDSCO licensing landscape can be complex, especially for niche devices like musculoskeletal infrared phototherapy units. Our extensive experience with 500+ successful approvals equips us to offer tailored support—ranging from document preparation, regulatory strategy, to audit readiness.
Engaging with experts early in your product development cycle minimizes compliance risks and accelerates market entry.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your device is Class B under CDSCO. Visit our Medical Device Classification resource for clarity.
Prepare Documentation: Begin compiling your Device Master File and Plant Master File using our comprehensive guides.
Apply for Test License (MD13): Submit the test license application via the CDSCO MD Online Portal to start product testing.
Plan Testing and Audits: Schedule product testing at authorized labs and arrange for notified body audits.
Submit Manufacturing License Application (MD5): Once tests and audits are complete, apply for the manufacturing license.
Monitor Application Status: Use the online portal to track your application and promptly respond to any CDSCO queries.
Taking these actionable steps early positions your company for a smooth, efficient approval process for musculoskeletal infrared phototherapy units in the Indian market.
For personalized assistance, connect with our regulatory consultants who specialize in CDSCO medical device licensing and ensure your compliance journey is hassle-free.