CDSCO License for Pain-relief phototherapy skin patch

Understanding the Pain-Relief Phototherapy Skin Patch and Its Regulatory Importance

The Pain-relief phototherapy skin patch is a cutting-edge medical device designed for pain management by reflecting naturally emitted infrared energy back into the body. This non-invasive patch targets strategic points on the skin to provide localized, temporary relief from body aches and pains through phototherapeutic stimulation. Given its unique mechanism and intended use, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is essential before entering the Indian market.

Navigating the regulatory landscape ensures the device's safety, efficacy, and quality, protecting end-users and building your brand’s credibility. As seasoned consultants with over 25 years of experience assisting 500+ companies, we provide you with a detailed roadmap tailored to your device—a Class B medical device under CDSCO classification.

CDSCO Regulatory Framework for Pain-Relief Phototherapy Skin Patch

Under CDSCO regulations, medical devices are classified into four risk categories: Class A (low risk), Class B (low moderate risk), Class C (moderate high risk), and Class D (high risk). Your pain-relief phototherapy skin patch is classified as Class B, meaning it requires a manufacturing license (MD5) granted by the State Licensing Authority.

This classification reflects the device’s moderate safety profile and intended use. Compliance with CDSCO’s guidelines, including device testing, quality management system (QMS), and audit requirements, is mandatory.

Risk Classification and License Requirements

Risk Class: B (Low Moderate Risk)
Applicable License: MD5 Manufacturing License
Application Form: MD3
Licensing Authority: State Licensing Authority
Total Processing Time: Approximately 3-4 months
Key Steps: Test license (MD13), product testing, audit by notified body, license grant (Form MD5)

For more detailed classification criteria, visit our Medical Device Classification guide.

Manufacturing License Process for MD5 (Class B Devices)

Step 1: Obtain Test License (Form MD13)

Before you apply for the manufacturing license, you must secure a test license for your device on Form MD13. This allows your products to be tested by CDSCO-approved laboratories. The test license typically takes 1.5 to 2 months to process.

Step 2: Product Testing

Your pain-relief phototherapy skin patch must be tested at government-approved labs to verify compliance with quality and safety standards. Refer to the list of testing laboratories for authorized centers.

Step 3: Documentation Preparation

Prepare comprehensive documentation, including the Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and quality system documents.

Step 4: Application Submission (Form MD3)

Submit the manufacturing license application through the CDSCO MD Online Portal along with all required documents.

Step 5: Audit by Notified Body

A notified body will conduct an audit of your manufacturing facility and QMS. Check the list of notified bodies authorized to perform MD5 audits.

Step 6: Queries and Clarifications

Respond promptly to any queries raised by the licensing authority or notified body to avoid delays.

Step 7: Grant of License

Upon successful audit and document verification, the State Licensing Authority will grant the MD5 manufacturing license on Form MD5.

For a detailed overview, consult our MD5 License Guide.

Manufacturing License Documents Required

Your application must include the following key documents:

Company Constitution (e.g., Certificate of Incorporation)
Proof of Ownership or Lease Agreement of Manufacturing Premises
Technical Staff Qualifications and Experience
Fire NOC and Pollution Control NOC
Device Master File (DMF) – Detailed device design and specifications
Plant Master File (PMF) – Manufacturing facility details
Essential Principles Checklist confirming compliance with regulatory standards
Risk Management File demonstrating hazard identification and mitigation strategies
Test Reports from CDSCO-approved laboratories
Product Labels and Instructions for Use (IFU)
Quality Management System Documents (ISO 13485:2016 recommended)

Our resource on creating a Plant Master File and Device Master File guide will assist you in compiling these documents efficiently.

Import License Process (MD15) for Phototherapy Skin Patch

If you plan to import this device into India, you must obtain an MD15 Import License from the Central Licensing Authority. The process generally takes 5-6 months and involves:

Document preparation including manufacturing license, Free Sale Certificate from the country of origin, ISO 13485 certification, and CE Certificate
Submission of application on Form MD14 via the CDSCO MD Online Portal
Resolution of any queries
Grant of import license on Form MD15

Refer to our detailed Import License Guide for comprehensive insights.

Import License Documents Required

Valid Manufacturing License from the country of origin
Free Sale Certificate
ISO 13485:2016 Certification
CE Certificate or equivalent
Device Master File
Plant Master File
Wholesale Drug License (if applicable)
Company Constitution Documents

Timeline and Processing Duration

Process Stage	Duration
Test License (MD13)	1.5 – 2 months
Product Testing	2 – 4 weeks
Document Preparation	2 – 4 weeks
Application Review and Audit	4 – 6 weeks
Query Resolution	2 – 4 weeks
License Granting	Immediately post clearance

Total estimated time: 3 to 4 months for MD5 license

Government Fees and Costs

Application Fee: Rs. 5,000 per application
Product Fee: Rs. 500 per product

These fees are payable online through the CDSCO MD Online Portal. Budgeting for additional costs related to product testing, notified body audits, and document preparation is essential.

Common Challenges and Solutions

Incomplete Documentation: Ensure all documents are current, properly formatted, and signed. Utilize checklists to avoid omissions.
Delays in Product Testing: Schedule testing early and choose certified labs to prevent bottlenecks.
Audit Readiness: Maintain ISO 13485 compliant QMS and conduct internal audits before notified body visits.
Responding to Queries: Assign a dedicated regulatory expert for prompt, accurate responses.

Our vast experience has equipped us to preempt these hurdles, ensuring smoother regulatory approvals.

Expert Consultation and Support

With over 25 years in CDSCO licensing, our consultancy has successfully guided 500+ manufacturers and importers through complex regulatory processes. We provide:

Tailored dossier preparation
Liaison with CDSCO and notified bodies
Pre-audit readiness assessments
Regulatory strategy planning

Engage with our experts early to streamline your journey.

Getting Started with Your CDSCO License Application

Conduct a Regulatory Gap Analysis: Assess your current compliance status against CDSCO requirements.
Prepare and Submit Test License (MD13): Start this as your first formal regulatory step.
Select Accredited Testing Laboratories: Plan and schedule product testing promptly.
Compile Required Documentation: Use our Device Master File and Plant Master File guides to assemble your dossier.
Submit Manufacturing License Application (Form MD3): Apply via the CDSCO MD Online Portal.
Prepare for Audit: Coordinate with notified bodies for audit scheduling.
Respond to Queries Promptly: Designate a regulatory point person.

By following these practical steps, you position your pain-relief phototherapy skin patch for timely approval and successful market entry in India.

For personalized assistance, contact us to leverage our expertise in navigating CDSCO licensing seamlessly.