CDSCO License for Euthyscope
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
A modified ophthalmoscope that projects a bright light encompassing an arc of approximately 30 degrees on the fundus of the eye for the treatment of amblyopia.
Introduction to Euthyscope and Its Regulatory Importance
Euthyscope is a specialized medical device designed for ophthalmology, specifically a modified ophthalmoscope that projects a bright light covering approximately 30 degrees of the eye's fundus. Its primary use is the treatment of amblyopia, a common vision disorder. Given its direct impact on patient safety and vision health, securing the appropriate CDSCO license is critical before manufacturing or marketing Euthyscope in India.
Navigating CDSCO regulations ensures compliance with Indian medical device laws and helps manufacturers avoid costly delays and legal complications. With over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we provide you with detailed, actionable guidance tailored for Euthyscope.
CDSCO Regulatory Framework for Ophthalmology Devices like Euthyscope
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. Ophthalmology devices, including Euthyscope, fall under this framework and must meet specific criteria before being allowed in the market.
Euthyscope is notified under File No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, which aligns it with CDSCO’s regulations for ophthalmic devices. Compliance with these notifications is mandatory.
Risk Classification and License Requirements for Euthyscope
Euthyscope is classified as a Class A medical device — the lowest risk category — due to its non-invasive nature and intended use. According to CDSCO guidelines:
- Class A devices require an MD5 Manufacturing License granted by the State Licensing Authority.
- The application involves submission of Form MD3.
- This license permits you to manufacture and market Euthyscope within India.
For more details on classification, check the Medical Device Classification guide.
Manufacturing License Process (MD5) for Euthyscope
The MD5 license process for a Class A device like Euthyscope typically spans 3 to 4 months. Here’s the step-by-step breakdown:
Obtain a Test License (Form MD13): Before applying for the manufacturing license, you must secure a test license (valid for 3-6 months). This takes about 1.5 to 2 months.
Product Testing: Conduct mandatory product testing at a CDSCO-approved laboratory to ensure compliance with Indian standards. You can find a list of Testing Laboratories authorized by CDSCO.
Document Preparation: Prepare comprehensive documents including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, and a Risk Management File.
Application Submission: Submit your application on the CDSCO MD Online Portal using Form MD3.
Audit by Notified Body: An audit by a notified body is mandatory. Refer to the official Notified Bodies List to select an auditor.
Query Resolution: Address any queries or observations raised by the licensing authority or notified body promptly.
License Grant: Upon successful completion, you will receive the MD5 license, allowing you to legally manufacture Euthyscope.
Manufacturing License Documents Required for Euthyscope
To streamline your application, ensure you have these documents ready:
- Company Constitution (Memorandum & Articles of Association)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) – detailing Euthyscope’s design and specifications (Device Master File Guide)
- Plant Master File (PMF) – describing your manufacturing facility (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with regulatory requirements
- Risk Management File demonstrating hazard identification and mitigation strategies (Risk Management)
- Product Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents, preferably ISO 13485 certified
Import License Process (MD15) for Euthyscope
If you intend to import Euthyscope instead of manufacturing it locally, you need to obtain an MD15 Import License from the Central Licensing Authority. The process typically takes 5 to 6 months and involves:
- Preparing detailed documents including the manufacturing license from the exporting country, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate if applicable, DMF and PMF, and wholesale license.
- Submission of application through the CDSCO MD Online Portal using Form MD14.
- Resolution of any queries raised by the authority.
- License grant on Form MD15.
Refer to our comprehensive Import License Guide for detailed steps.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate or equivalent
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license in India
- Company Constitution
Timeline and Processing Duration
| License Type | Processing Time | Notes |
|---|---|---|
| Test License (MD13) | 1.5 – 2 months | Mandatory first step |
| MD5 Manufacturing License | 3 – 4 months | Includes audit and query resolution |
| MD15 Import License | 5 – 6 months | No test license required |
Government Fees and Costs for Euthyscope (Class A Device)
MD5 Manufacturing License:
- Application fee: Rs. 5,000
- Per product fee: Rs. 500 (for Euthyscope, as a single product)
Test License (MD13):
- Nominal fee as per state authority guidelines
Import License (MD15):
- $1,000 per site
- $50 per product
These fees are subject to periodic revision; always verify current fees on the CDSCO MD Online Portal.
Common Challenges and Solutions in Licensing Euthyscope
Challenge: Delays in product testing due to lab backlogs.
- Solution: Engage with a CDSCO-approved testing laboratory early and schedule testing slots in advance.
Challenge: Incomplete or inconsistent documentation.
- Solution: Use checklists and templates for DMF, PMF, and Risk Management files to ensure thoroughness.
Challenge: Audit non-compliance due to inadequate QMS or facility gaps.
- Solution: Conduct internal audits and pre-assessment before notified body visits.
Challenge: Regulatory queries causing delays.
- Solution: Respond promptly and with complete information; seek expert advice if needed.
Expert Consultation and Support
With our extensive experience assisting over 500 companies, we offer tailored consulting services for Euthyscope manufacturers and importers. From document preparation to audit readiness and query management, our experts guide you through the entire CDSCO licensing journey with proven strategies to minimize delays and ensure compliance.
Getting Started with Your CDSCO License Application for Euthyscope
- Assess Device Classification: Confirm Euthyscope’s Class A status and applicability of MD5 license.
- Prepare Documentation: Begin drafting your Device Master File and Plant Master File using our recommended guides.
- Apply for Test License: Submit Form MD13 through the CDSCO MD Online Portal to initiate product testing.
- Schedule Testing: Engage a CDSCO-approved testing lab early to avoid bottlenecks.
- Plan for Audit: Coordinate with a notified body listed here to schedule your audit after test results.
- Submit MD5 Application: Once testing and audit are complete, submit Form MD3 online.
- Monitor Application: Track your license status and respond to queries promptly.
By following these practical steps and relying on expert guidance, your journey to obtain the CDSCO manufacturing license for Euthyscope can be smooth, timely, and successful.
For further assistance, contact our regulatory experts who specialize in ophthalmology devices and CDSCO licensing compliance.
