CDSCO License for Skin transilluminator, line-powered

Comprehensive Guide to CDSCO Licensing for Skin Transilluminator (Line-Powered) – Class C Medical Device

As specialists with over 25 years of experience in navigating the complex regulatory landscape of medical devices in India, we have successfully supported over 500 companies to obtain their CDSCO licenses. If you are manufacturing or importing a Skin Transilluminator, line-powered, categorized under Class C risk, this detailed guide will help you understand the regulatory framework, licensing requirements, and practical steps to bring your device to the Indian market efficiently.

Introduction to Skin Transilluminator and Regulatory Importance

A Skin Transilluminator is a hand-held, mains electricity-powered device used primarily in pediatrics and neonatology to illuminate skin and soft tissues. It aids clinicians in visualizing subcutaneous lesions, veins, or scrotal contents by rendering tissues translucent. Known also as a diaphanoscope or phaneroscope, its clinical importance demands strict compliance with regulatory standards to ensure safety and efficacy.

Given its Class C classification as per CDSCO guidelines, adherence to a stringent approval process is mandatory before marketing this device in India. This process ensures the device meets quality, safety, and performance benchmarks essential for patient safety.

CDSCO Regulatory Framework for Skin Transilluminator (Class C)

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Ministry of Health and Family Welfare. For Class C devices like the Skin Transilluminator, the regulatory framework mandates obtaining an MD9 Manufacturing License (if manufacturing in India) or an MD15 Import License (for importers).

The licensing is conducted by the Central Licensing Authority (CLA), involving pre-market testing, document scrutiny, and factory audits to verify compliance with the Medical Device Rules, 2017.

Risk Classification and License Requirements

Based on the Medical Device Classification notified by CDSCO, the Skin Transilluminator falls under Class C due to its invasive application and potential moderate risk impact.

• License Type: MD9 (Manufacturing) or MD15 (Import)
• Authority: Central Licensing Authority
• Timeline: 4-5 months for MD9, 5-6 months for MD15
• Fees: ₹50,000 + ₹1,000 per product (MD9), variable for MD15 as per risk class

Manufacturing License Process (MD9) for Skin Transilluminator

The MD9 license process for Class C devices involves several critical steps:

1. Obtain Test License (MD13): Apply for a test license on Form MD13 to legally manufacture and conduct product testing. This step takes approximately 1.5-2 months.

2. Product Testing: Get the Skin Transilluminator tested at CDSCO-approved laboratories to verify compliance with applicable standards. Refer to the Testing Laboratories list for authorized labs.

3. Document Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.

4. Application Submission: Submit the MD9 application on Form MD7 via the CDSCO MD Online Portal along with required fees.

5. Audit and Inspection: CDSCO inspectors conduct a thorough audit of the manufacturing facility and QMS.

6. Query Resolution: Respond promptly to any queries raised by CDSCO or the notified body.

7. Grant of License: Upon successful evaluation, CDSCO issues the MD9 license granting permission to manufacture.

For a detailed walkthrough, our MD9 License Guide offers stepwise insights.

Manufacturing License Documents Required

Preparing a complete dossier is critical. The following documents are typically required:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Premises
• Details and Qualifications of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design, manufacturing process, and specifications (Device Master File Guide)
• Plant Master File describing the facility, equipment, and quality control processes (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with safety standards
• Risk Management File documenting hazard analysis and mitigation (Risk Management)
• Product Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (e.g., ISO 13485:2016 certifications)

Import License Process (MD15) for Skin Transilluminator

For importers, the process involves:

1. Document Preparation: Prepare all relevant documents including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, wholesale license, and company constitution.

2. Application Submission: File application on Form MD14 for MD15 license via the CDSCO MD Online Portal.

3. Query Resolution: Address any queries from CDSCO promptly.

4. Grant of Import License: Upon satisfactory review, CDSCO issues the MD15 license.

Unlike manufacturing licenses, a test license is not mandatory here. The import license timeline generally spans 5-6 months.

Detailed import process insights can be found in our Import License Guide.

Timeline and Processing Duration

For Import License (MD15), the total duration is approximately 5-6 months without test license requirement.

Government Fees and Costs

• MD9 License Fees: ₹50,000 per application + ₹1,000 per product
• MD13 Test License Fees: ₹5,000 + ₹500 per product (if applicable)
• MD15 Import License Fees: Varies by class; for Class C devices approximately ₹3,000 per site + ₹1,500 per product

Timely payment of fees through the CDSCO portal ensures smoother processing.

Common Challenges and Practical Solutions

• Delayed Product Testing: Plan testing early and confirm schedules with approved labs.
• Incomplete Documentation: Use comprehensive checklists and expert reviews to avoid missing critical documents like Risk Management File or Essential Principles Checklist.
• Audit Non-compliance: Prepare for audits by conducting internal mock inspections focusing on manufacturing practices and QMS adherence.
• Query Management: Maintain a dedicated regulatory liaison to respond promptly and comprehensively to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing can be daunting. Our extensive experience with over 500 successful licensing projects positions us to provide tailored support:

• End-to-end license application management
• Document gap analysis and preparation
• Coordination with notified bodies (refer to the List of Notified Bodies)
• Pre-audit readiness and training
• Regulatory updates and compliance strategy

Getting Started with Your CDSCO License Application

For manufacturers or importers planning to enter the Indian market with your Skin Transilluminator (Class C), follow these practical steps:

1. Verify Device Classification: Confirm Class C status and applicable standards.
2. Initiate Test License Application (if manufacturing): Prepare and submit Form MD13.
3. Engage Accredited Testing Laboratories: Schedule product testing early.
4. Compile Comprehensive Documentation: Utilize our guides for DMF, PMF, and Risk Management.
5. Submit Application Online: Use the official CDSCO MD Online Portal for application submission.
6. Prepare for Audits: Conduct internal reviews and corrective actions.
7. Maintain Active Communication: Respond swiftly to regulatory queries.

By following these actionable steps and partnering with experienced consultants, you can significantly reduce approval time and ensure successful market access.

For personalized assistance and to streamline your CDSCO licensing journey, reach out to our expert team today.