CDSCO License for Ophthalmoleukoscope
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
An ophthalmic device intended to be used for testing colour perception by means of colours produced by polarized light.
Introduction to Ophthalmoleukoscope and Its Regulatory Importance
The ophthalmoleukoscope is a specialized ophthalmic device designed to test color perception using colors produced by polarized light. In India, such medical devices fall under the regulatory purview of the Central Drugs Standard Control Organization (CDSCO), ensuring safety, efficacy, and quality before market entry. Given its classification as a Class A device, ophthalmoleukoscopes are subject to specific regulatory requirements that manufacturers and importers must carefully navigate. With over 25 years of experience and having supported 500+ companies, we understand the nuances involved in securing your CDSCO license efficiently.
CDSCO Regulatory Framework for Ophthalmoleukoscope
The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, which categorize devices based on risk, intended use, and complexity. Ophthalmoleukoscopes, notified under Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, are classified as Class A (low risk) devices within the ophthalmology category. Consequently, the regulatory framework mandates obtaining an MD5 manufacturing license from the State Licensing Authority.
Risk Classification and License Requirements
Class A devices like the ophthalmoleukoscope are considered low risk, requiring the following:
- License Type: MD5 Manufacturing License
- Application Form: MD3
- Regulatory Authority: State Licensing Authority
- Total Processing Time: Approximately 3-4 months
- Fee Structure: Rs 5,000 per application + Rs 500 per product
Manufacturers must also obtain a test license (MD13) before final license application.
Manufacturing License Process (MD5) for Ophthalmoleukoscope
The MD5 licensing process is a multi-step journey:
Test License Application (Form MD13): Initiate with this mandatory license allowing product testing in CDSCO-approved labs. Processing takes about 1.5 to 2 months.
Product Testing: Conduct tests at government-approved laboratories to verify conformity with Indian standards. Refer to the Testing Laboratories list for authorized labs.
Document Preparation: Compile required documents including Device Master File, Plant Master File, and technical files.
License Application Submission (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal with all supporting documents.
Audit by Notified Body: An audit is conducted by a notified body. Review the Notified Bodies list to select an auditor.
Resolution of Queries: Respond promptly to any queries raised by the licensing authority or notified body.
Grant of License (Form MD5): Upon satisfactory evaluation, the license is granted.
Manufacturing License Documents Required for Ophthalmoleukoscope
To ensure a smooth application, prepare the following:
- Company Constitution (Incorporation Certificate, MoA, AoA)
- Proof of Ownership/Lease of Manufacturing Premises
- Details and qualifications of technical and quality personnel
- Fire Safety NOC
- Pollution Control Board NOC
- Device Master File (DMF) — covering device specifications, manufacturing process, and quality controls. Our detailed Device Master File guide can assist you.
- Plant Master File (PMF) — documenting manufacturing infrastructure and quality systems. Learn more in our Plant Master File guide.
- Essential Principles Checklist confirming compliance with Indian MDR
- Risk Management File detailing hazard analysis and mitigation per the Risk Management guidelines.
- Test Reports from CDSCO-approved labs
- Labeling and Instructions for Use (IFU) compliant with MDR
- Quality Management System (QMS) documentation (ISO 13485:2016 recommended)
Import License Process (MD15) for Ophthalmoleukoscope
Since the ophthalmoleukoscope is a Class A device, importers must obtain an MD15 license granted by the Central Licensing Authority:
- Application Form: MD14
- Processing Duration: Approximately 5-6 months
- Fees: Varies by class; for Class A, typically Rs 75,000 (converted approx.) including site and product fees
The process involves document preparation, submission via the CDSCO portal, query resolution, and license grant. Importers must possess relevant manufacturing licenses from the country of origin, ISO certification, CE marking (if applicable), and other compliance documents.
Our Import License Guide offers comprehensive assistance tailored for ophthalmic devices.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) Application | 1.5 - 2 months |
| Product Testing | 3-4 weeks |
| Document Preparation | 2-3 weeks |
| License Application (MD3) | Immediate on portal |
| Audit by Notified Body | 3-4 weeks |
| Query Resolution | 2-3 weeks |
| Final License Grant (MD5) | Within 1 week post clearance |
Overall, expect 3 to 4 months from test license initiation through final manufacturing license grant.
Government Fees and Costs
- Test License (MD13): Typically Rs 5,000
- MD5 License Application: Rs 5,000 per application + Rs 500 per product
- Audit Fees: Variable, paid to notified body (approx Rs 30,000–50,000)
- Product Testing Fees: Depends on test complexity and lab rates
Budgeting accurately for these costs is critical. We advise clients to allocate sufficient time and resources upfront to avoid delays.
Common Challenges and Solutions
Incomplete Documentation: Many applicants face delays due to missing or inconsistent documents. Solution: Use checklists and our expert reviews to ensure completeness.
Delays in Product Testing: Limited slots at government labs can cause bottlenecks. Solution: Schedule testing early and consider multiple approved labs.
Audit Non-Compliance: Non-adherence to QMS or facility standards leads to audit failures. Solution: Conduct internal audits and gap assessments before notified body visits.
Query Resolution Delays: Slow responses to CDSCO queries prolong timelines. Solution: Prepare a dedicated team to address queries promptly and thoroughly.
Expert Consultation and Support
Navigating the MD5 licensing pathway for devices like the ophthalmoleukoscope requires specialized knowledge. Our team, with over two decades of regulatory consulting experience, offers end-to-end support—from document preparation and gap analysis to audit readiness and application submission.
We also provide tailored training on medical device regulatory compliance, risk management, and quality systems implementation.
Getting Started with Your CDSCO License Application for Ophthalmoleukoscope
Assess Your Device Classification: Confirm that your ophthalmoleukoscope falls under Class A using trusted classification tools, such as our Medical Device Classification resource.
Initiate Test License Application (MD13): Prepare required documents and submit your application through the CDSCO MD Online Portal.
Plan Product Testing: Contact approved testing labs early; coordinate timelines and sample delivery.
Compile Comprehensive Documentation: Utilize our Device Master File and Plant Master File guides to ensure thoroughness.
Engage a Notified Body: Select an accredited notified body from the official list and schedule your audit.
Submit MD5 License Application: Once testing and document readiness are complete, apply via the CDSCO portal.
Prepare for Audit and Queries: Conduct internal reviews, prepare your team, and respond swiftly to any requests.
Obtain Your License and Commence Manufacturing: After license grant, ensure ongoing compliance with MDR and quality standards.
By following these actionable steps and leveraging our expertise, manufacturers and importers can successfully bring ophthalmoleukoscopes to the Indian market with confidence and compliance.
