CDSCO License for Blue/red/infrared phototherapy lamp
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
Intended to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness).
Comprehensive Guide to CDSCO Licensing for Blue/Red/Infrared Phototherapy Lamps (Class A Medical Device)
Phototherapy lamps emitting blue, red, and infrared light serve a vital role in rehabilitation by facilitating treatment for mild skin disorders, superficial wounds, and musculoskeletal symptoms. Given their intended therapeutic use, these devices are categorized under Class A risk in India’s medical device regulatory framework. Navigating the CDSCO licensing process efficiently is crucial for manufacturers and importers eager to launch these phototherapy lamps in the Indian market.
With over 25 years of regulatory consultancy experience and having assisted more than 500 companies, we provide you with detailed insights and actionable steps tailored specifically for the Blue/Red/Infrared Phototherapy Lamp.
CDSCO Regulatory Framework for Phototherapy Lamps
The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India under the Medical Device Rules, 2017. Your phototherapy lamp falls under the Rehabilitation category and is classified as a Class A device—signifying low risk.
Under the CDSCO framework, Class A devices require a manufacturing license known as the MD5 license, which is issued by the State Licensing Authority. This license ensures compliance with quality, safety, and efficacy standards before marketing.
For detailed classification, you can refer to our Medical Device Classification guide.
Risk Classification and License Requirements for Phototherapy Lamps
| Device Type | Risk Class | License Type | Licensing Authority | Timeline | Fees (INR) |
|---|---|---|---|---|---|
| Blue/Red/Infrared Phototherapy Lamp | A | MD5 | State Licensing Authority | 3-4 months | Rs 5000 + Rs 500/product |
As a Class A device, your phototherapy lamp requires an MD5 manufacturing license. This involves:
- Initial application for a Test License (Form MD13)
- Product testing at CDSCO-approved laboratories
- Submission of required documentation
- Audit by a CDSCO-notified body
- Resolution of queries
- Grant of final MD5 license
You can initiate your application via the CDSCO MD Online Portal.
Manufacturing License Process (MD5) for Blue/Red/Infrared Phototherapy Lamps
Step 1: Obtain Test License (Form MD13)
Before applying for the MD5 license, manufacturers must obtain a test license, granting permission to manufacture prototype products for testing. This stage typically takes 1.5 to 2 months.
Step 2: Product Testing
Testing must be conducted at government-approved labs to verify compliance with the essential principles of safety and performance. You can find an updated list of Testing Laboratories recognized by CDSCO.
Step 3: Documentation and Application
Prepare your application for the MD5 license using Form MD3. Detailed documentation is critical here; incomplete or inaccurate documents cause delays.
Step 4: Audit by Notified Body
An audit of your manufacturing facility and quality management system is conducted by a CDSCO-empaneled notified body. For Class A devices, this audit verifies compliance with Good Manufacturing Practices.
Refer to the list of notified bodies authorized for MD5 audits.
Step 5: Resolution of Queries
After audit and document submission, CDSCO or the notified body may raise queries. Prompt, thorough responses from your end are essential to avoid prolonged processing.
Step 6: Grant of MD5 License
Upon clearing all requirements, the State Licensing Authority grants the MD5 license (Form MD5), allowing you to manufacture and market your phototherapy lamps legally in India.
Manufacturing License Documents Required
For your blue/red/infrared phototherapy lamp, the following documents must be submitted:
- Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Details (Qualifications and experience of key personnel)
- Fire NOC and Pollution Control NOC
- Device Master File (DMF)
- Plant Master File (PMF)
- Essential Principles Checklist confirming compliance with safety and performance
- Risk Management File specific to phototherapy lamp hazards
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents
Our comprehensive Device Master File guide and Plant Master File guide explain preparation details.
Import License Process (MD15) for Phototherapy Lamps
If you are an importer, the MD15 license is mandatory. This license is granted by the Central Licensing Authority and usually takes 5-6 months to process.
Unlike manufacturing licenses, the import license does not require a test license first. However, you must submit:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Fees vary by risk class and product quantity. You can start your application on the CDSCO MD Online Portal.
For detailed guidance, consult our Import License guide.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| License Application & Audit | 1 - 1.5 months |
| Query Resolution & Final Grant | 2 - 3 weeks |
Total time: Approximately 3 to 4 months for manufacturing license (MD5).
Planning accordingly and starting early with robust documentation can reduce bottlenecks.
Government Fees and Costs
- MD5 Application Fee: Rs 5,000 per application
- Per Product Fee: Rs 500
Costs cover application processing, audits, and administrative expenses. Budgeting for testing and preparing high-quality documentation is essential but varies by vendor.
Common Challenges and Practical Solutions
- Delays Due to Incomplete Documentation: Ensure all files, especially Device and Plant Master Files, adhere strictly to CDSCO formats and guidelines.
- Testing Lab Backlogs: Engage with CDSCO-approved labs early. We recommend scheduling tests in advance to prevent delays.
- Audit Non-Compliance: Conduct internal pre-audit checks and training for staff to meet Good Manufacturing Practices.
- Query Resolution Delays: Assign dedicated regulatory personnel for prompt responses.
Our expert team regularly helps manufacturers mitigate these issues to expedite approvals.
Expert Consultation and Support
Navigating CDSCO processes for phototherapy lamps requires specialized expertise. Our 25+ years of experience and success with 500+ companies enable us to offer:
- Customized regulatory strategy
- End-to-end application management
- Document preparation and review
- Pre-audit readiness assessments
- Liaison support with CDSCO and notified bodies
Partnering with experts reduces risk, saves time, and ensures compliance.
Getting Started with Your CDSCO License Application
- Assess your device classification and confirm the need for MD5 license.
- Prepare essential documentation, focusing on Device Master File and Risk Management.
- Apply for the Test License (Form MD13) through the CDSCO MD Online Portal.
- Schedule product testing with CDSCO-approved labs.
- Plan and conduct notified body audit post-testing.
- Submit Form MD3 for MD5 License along with all supporting documents.
- Respond promptly to any queries raised by CDSCO or auditors.
Starting early and following a structured approach enhances your chances of swift approval and market entry.
For detailed assistance, review our in-depth MD5 License Guide and contact our regulatory consultants to tailor the process for your specific product.
By adhering to these guidelines and leveraging expert support, manufacturers and importers of blue/red/infrared phototherapy lamps can confidently achieve CDSCO licensing compliance and successfully enter the Indian healthcare market.
