CDSCO License for Keratoscope
Medical Device Information
Intended Use
A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope and videokeratoscope which records corneal curvature by taking photographs or videos of the cornea.
Comprehensive Guide to CDSCO Licensing for Keratoscope (Class B Medical Device)
Keratoscopes play a crucial role in ophthalmology by enabling precise measurement and evaluation of the corneal curvature. Whether AC or battery-powered, these devices—including photokeratoscopes and videokeratoscopes—are indispensable for diagnosing corneal conditions through corneal reflex analysis. Given their medical significance and classification as Class B devices under the CDSCO regulatory framework, obtaining the appropriate manufacturing or import license is mandatory to market a keratoscope in India.
With over 25 years of regulatory consulting experience and having supported 500+ companies, we provide a detailed roadmap to navigate the licensing process smoothly, ensuring compliance with Indian regulations.
CDSCO Regulatory Framework for Keratoscope (Class B Device)
The Central Drugs Standard Control Organisation (CDSCO) governs medical device regulation in India, under the Ministry of Health and Family Welfare. The keratoscope falls under the ophthalmology category and is notified under Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021. As a Class B device, it is considered low to moderate risk, mandating specific compliance requirements including manufacturing license (MD5) or import license (MD15).
Risk Classification and License Requirements for Keratoscope
Keratoscopes are classified as Class B devices due to their diagnostic nature and moderate risk potential. This classification requires manufacturers to obtain the MD5 manufacturing license from the State Licensing Authority. Importers must acquire the MD15 import license from the Central Licensing Authority.
| License Type | Responsible Authority | Timeline | Fees (INR) |
|---|---|---|---|
| MD5 (Manufacturing) | State Licensing Authority | 3-4 months | Rs 5,000 + Rs 500 per product |
| MD15 (Import) | Central Licensing Authority | 5-6 months | Fees vary by class & product |
Manufacturing License Process for Keratoscope (MD5 License)
For manufacturers of the keratoscope, the MD5 license is mandatory. The process is as follows:
- Obtain Test License (Form MD13): Apply for a test license valid for 1.5-2 months to legally manufacture and conduct testing.
- Product Testing: Get keratoscope samples tested at CDSCO-approved testing laboratories listed here.
- Document Preparation: Compile all required documentation including Device Master File, Plant Master File, and QMS documents.
- License Application (Form MD3): Submit the application for MD5 manufacturing license via the CDSCO MD Online Portal.
- Audit by Notified Body: Engage a notified body for an audit; a list of notified bodies for MD5 is available here.
- Respond to 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.
For detailed insights, refer to our MD5 License Guide.
Manufacturing License Documents Required for Keratoscope
Accurate and thorough documentation is vital. For your keratoscope MD5 license, prepare:
- Company Constitution (Incorporation Certificate, MOA & AOA)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing device design and specifications (Guide here)
- Plant Master File (PMF) describing manufacturing facility and processes (Guide here)
- Essential Principles Checklist affirming compliance with safety standards
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management Guide)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (ISO 13485:2016 compliance preferred)
Import License Process for Keratoscope (MD15 License)
Importers seeking to bring keratoscopes into India must obtain an MD15 license from the Central Licensing Authority. The process involves:
- Document Preparation: Collect required documents including manufacturing license from country of origin, Free Sale Certificate, CE Certificate, and technical files.
- License Application (Form MD14): Submit the application for MD15 license on the CDSCO MD Online Portal.
- Query Resolution: Address any additional information requests from CDSCO promptly.
- Grant of License (Form MD15): After evaluation, the import license is issued.
Refer to our comprehensive Import License Guide for specific procedural details.
Import License Documents Required for Keratoscope
The import license application must include:
- Manufacturing License from the country of origin
- Free Sale Certificate confirming product marketing approval abroad
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File (DMF)
- Plant Master File (PMF)
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 1 month (overlaps with testing) |
| MD5 Application & Audit | 1 – 1.5 months |
| Query Resolution | 2 – 4 weeks |
| Total (Manufacturing) | 3 – 4 months approx |
Import license (MD15) typically takes 5-6 months due to central authority processing and detailed technical evaluations.
Government Fees and Costs
For Keratoscope (Class B device):
- MD5 License: Rs 5,000 per application + Rs 500 per product
- MD15 Import License: Fees vary by class & products, typically higher for Class B; refer to CDSCO fee schedules.
Additional costs include:
- Testing fees at CDSCO-approved labs
- Notified body audit charges
- Professional consultancy fees (if applicable)
Budgeting realistically for these expenses helps avoid delays.
Common Challenges and Solutions
Challenge: Delays in product testing due to limited CDSCO-approved labs.
Solution: Plan testing early and select labs with demonstrated turnaround times. Utilize the Testing Laboratories list proactively.
Challenge: Incomplete or inconsistent documentation causing repeated queries.
Solution: Use comprehensive templates for Device and Plant Master Files; ensure alignment with notified body and CDSCO checklists.
Challenge: Audit non-compliance findings.
Solution: Conduct internal pre-audits and corrective action processes before notified body inspections.
Expert Consultation and Support
Navigating CDSCO licensing for a keratoscope can be complex. Leveraging expert consultants with extensive experience can significantly reduce approval time and improve compliance reliability. Our team has assisted numerous manufacturers and importers in securing timely approvals through end-to-end support—from documentation to audit readiness.
Getting Started with Your CDSCO License Application for Keratoscope
- Assess Your Device Classification: Confirm your keratoscope’s Class B status.
- Plan Your Licensing Path: Decide whether you are manufacturing in India (MD5) or importing (MD15).
- Gather Essential Documents: Use our guides on Device Master File and Plant Master File to prepare your submission package.
- Register on the CDSCO MD Online Portal: Submit your application forms and track progress seamlessly.
- Engage with Notified Bodies Early: Schedule pre-audit consultations to ensure compliance.
- Prepare for Testing: Choose CDSCO-approved labs and initiate sample testing.
Embarking on your CDSCO licensing journey with informed planning and expert support ensures your keratoscope reaches the Indian market efficiently and compliantly. For personalized assistance, connect with us to leverage our 25+ years of regulatory expertise.
