CDSCO License for Skin transilluminator, battery-powered
Medical Device Information
Intended Use
A hand-held, battery-powered device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner.
Comprehensive Guide to CDSCO Licensing for Skin Transilluminators (Battery-Powered)
Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized equipment like the skin transilluminator. This hand-held, battery-powered device, categorized under Pediatrics and Neonatology, serves a vital role in clinical examination by illuminating subcutaneous tissues for diagnostic purposes. Classified as a Class C device under the CDSCO framework, it requires a meticulous licensing process to ensure safety, efficacy, and compliance before entering the Indian market.
With over 25 years of experience assisting 500+ manufacturers and importers, we provide you with an expert, step-by-step overview of the regulatory requirements, timelines, costs, and documentation essential for obtaining your CDSCO license for this device.
CDSCO Regulatory Framework for Skin Transilluminators
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017, which classify devices according to risk. The skin transilluminator falls under Class C due to its invasive nature and critical use in vulnerable populations like neonates.
The licensing process for Class C devices involves obtaining a manufacturing license (MD9) if produced domestically or an import license (MD15) if imported. Both licenses are issued by the Central Licensing Authority, emphasizing stringent compliance measures including product testing, audits, and documentation.
Risk Classification and License Requirements for Skin Transilluminators
Class C devices carry moderate to high risk. The skin transilluminator’s role in pediatrics and neonatology, combined with its diagnostic application, places it firmly in this category. Consequently, manufacturers must apply for the MD9 manufacturing license using Form MD7, while importers require an MD15 import license via Form MD14.
Understanding this classification is critical as it dictates the entire regulatory pathway, including testing, audits, and fees. For a detailed classification overview, refer to our Medical Device Classification guide.
Manufacturing License Process (MD9) for Skin Transilluminators
The MD9 license process for Class C devices involves several key steps:
- Test License Application (Form MD13): Before full manufacturing license application, a test license is mandatory. This allows production of samples for mandatory testing.
- Product Testing: Samples must be tested at government-approved laboratories listed on the CDSCO Testing Laboratories.
- Document Preparation: Compile comprehensive technical documentation, including Device Master File (DMF), Plant Master File (PMF), risk management, and quality management system (QMS) evidence.
- License Application (Form MD7): Submit the manufacturing license application via the CDSCO MD Online Portal.
- Audit: CDSCO inspectors conduct a thorough audit of the manufacturing premises and quality systems.
- Query Resolution: Address any concerns or queries raised during the audit.
- License Grant (Form MD9): Upon satisfactory compliance, the license is granted.
This process typically spans 4 to 5 months.
Manufacturing License Documents Required
For your skin transilluminator, you must prepare the following documents:
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed device design, specifications, and manufacturing process documentation (see our Device Master File guide)
- Plant Master File (PMF): Description of manufacturing facility and quality control systems (Plant Master File guide)
- Essential Principles Checklist demonstrating compliance with safety and performance requirements
- Risk Management File outlining identified risks and mitigations (Risk Management guide)
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU) adhering to CDSCO specifications
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification
Import License Process (MD15) for Skin Transilluminators
If you plan to import the skin transilluminator, the MD15 import license is mandatory. The process includes:
- Document Preparation: Assemble manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE certificate, DMF, PMF, wholesale license, and company registration documents.
- Application Submission: File the application on the CDSCO MD Online Portal.
- Query Resolution: Collaborate with CDSCO to address any queries.
- License Grant: Typically completed within 5 to 6 months.
Import License Documents Required
Key documents needed for MD15 application:
- Manufacturing License from exporting country
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale Drug License for distribution in India
- Company Incorporation Certificates
Timeline and Processing Duration
| License Type | Process Duration | Key Milestones |
|---|---|---|
| MD9 Manufacturing License | 4-5 months | Test License (1.5-2 months), Testing, Audit, Query Resolution |
| MD15 Import License | 5-6 months | Document Review, Query Resolution, License Grant |
Planning your project timeline with these durations in mind will help avoid costly delays.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 License | ₹50,000 | ₹1,000 |
| MD15 Import | Class C: ₹3,000/site | ₹1,500 per product |
Additional costs include testing fees at government labs and audit-related expenses. Budgeting for these early will streamline your application process.
Common Challenges and Solutions
- Delayed Testing Results: Partner only with CDSCO-approved labs to ensure reliable timelines.
- Incomplete Documentation: Utilize checklists and expert review to avoid rejections.
- Audit Non-Compliance: Conduct pre-audit internal assessments; consider consulting with notified bodies (Notified Bodies List).
- Query Management: Respond promptly and thoroughly to CDSCO queries to prevent delays.
Expert Consultation and Support
Our extensive experience with over 500 successful CDSCO license applications uniquely positions us to guide you through each stage. From document preparation to audit readiness and query handling, our team ensures your skin transilluminator's regulatory journey is smooth and efficient.
Getting Started with Your CDSCO License Application
- Classify Your Device: Confirm your device’s risk class; skin transilluminator is Class C.
- Engage a Testing Laboratory: Select a government-approved lab for mandatory product testing.
- Prepare Documentation: Develop your Device and Plant Master Files and compile all technical and legal documents.
- Apply for Test License: Submit Form MD13 for test license via the CDSCO MD Online Portal.
- Plan for Audit: Initiate internal audits and quality system reviews ahead of CDSCO inspections.
- Submit Manufacturing License Application: File Form MD7 after successful testing.
By following these practical steps and leveraging expert support, your battery-powered skin transilluminator can achieve timely regulatory approval, enabling access to the growing Indian pediatric healthcare market.
For personalized assistance or to start your application, contact our regulatory experts today.
