CDSCO License for Hruby fundus lens
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 55 dioptre non-contact diagnostic ophthalmic lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.
Comprehensive CDSCO Licensing Guide for Hruby Fundus Lens (Class A Ophthalmic Device)
Introduction: Understanding the Hruby Fundus Lens and Its Regulatory Importance
The Hruby fundus lens is a specialized 55 dioptre non-contact diagnostic ophthalmic lens designed for detailed examination of the vitreous body and fundus under slitlamp illumination and magnification. Given its critical role in ophthalmology diagnostics, regulatory compliance is essential to ensure safety, efficacy, and market access in India.
As a Class A medical device under the CDSCO framework, the Hruby fundus lens is considered low risk. However, obtaining the appropriate CDSCO license is mandatory before manufacturing or importing this device. With over 25 years of regulatory experience and having assisted 500+ companies, we provide a clear, step-by-step roadmap to secure your license efficiently.
CDSCO Regulatory Framework for Hruby Fundus Lens
The Hruby fundus lens falls under the ophthalmology category and is notified under Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021. As per CDSCO regulations, this device is classified as Class A — the lowest risk category, which means it requires licensing through the State Licensing Authority via the MD5 manufacturing license process.
To comply, manufacturers must navigate the CDSCO medical device regulatory framework that mandates:
- Obtaining a Test License (Form MD13) for product testing
- Product testing at CDSCO-approved laboratories
- Submission of comprehensive documentation including Device Master File and Plant Master File
- Audit by a notified body
- Final grant of the MD5 license (Form MD3 application, license issued on Form MD5)
Risk Classification and License Requirements for Hruby Fundus Lens
| Parameter | Details |
|---|---|
| Device Name | Hruby Fundus Lens |
| Risk Class | Class A (Low risk) |
| Intended Use | Diagnostic ophthalmic lens for vitreous and fundus examination |
| Regulatory Process | MD5 License via State Licensing Authority |
For this device, the MD5 license process is mandatory before commencing manufacturing or marketing.
Manufacturing License Process (MD5) for Hruby Fundus Lens
The MD5 manufacturing license is administered by the State Licensing Authority. The entire process typically spans approximately 3 to 4 months, broken down as follows:
- Test License Application (Form MD13): Takes 1.5 to 2 months to obtain. This interim license authorizes testing of the device.
- Product Testing: Conduct testing at CDSCO-approved laboratories to assess compliance with essential principles.
- Documentation Preparation: Compile required documents including Device Master File, Plant Master File, and Quality Management System (QMS) documents.
- License Application (Form MD3): Apply for the MD5 manufacturing license through the CDSCO MD Online Portal.
- Audit by Notified Body: An audit from an authorized notified body is mandatory. You can find the list of notified bodies here.
- Query Resolution: Address any queries raised by the licensing authority or notified body.
- Grant of License (Form MD5): Upon satisfactory review, the license is granted allowing manufacturing.
Manufacturing License Documents Required for Hruby Fundus Lens
The documentation package is comprehensive and must be meticulously prepared to avoid delays:
- Company Constitution: Registration certificates, memorandum of association, and incorporation documents.
- Proof of Ownership or Lease of Premises: Property documents or lease agreements.
- Technical Staff Details: Qualification certificates and experience proof of technical personnel.
- Fire and Pollution NOCs: No objection certificates from local authorities.
- Device Master File (DMF): Detailed design, specifications, and manufacturing process of the Hruby fundus lens. For guidance, refer to our Device Master File guide.
- Plant Master File (PMF): Details of the manufacturing facility, equipment, and quality control measures. Learn more via our Plant Master File guide.
- Essential Principles Checklist: Compliance checklist confirming adherence to CDSCO standards.
- Risk Management File: Documentation of risk analysis and mitigation strategies relevant to this ophthalmic device (see our Risk Management resource).
- Test Reports: From CDSCO-approved testing laboratories; you can locate them here.
- Labels and Instructions for Use (IFU): Drafts adhering to regulatory labeling requirements.
- Quality Management System Documents: Procedures, SOPs, and certifications such as ISO 13485.
Import License Process (MD15) for Hruby Fundus Lens
For importers of the Hruby fundus lens, the CDSCO mandates an MD15 import license issued by the Central Licensing Authority. The process is slightly longer, typically 5 to 6 months, and requires:
- Preparation of import-specific documentation including Free Sale Certificate, CE Certificate, and ISO 13485:2016.
- Application submission on the CDSCO MD Online Portal.
- Resolution of any queries from CDSCO.
- Final grant of MD15 license.
Note: Unlike manufacturing, import licensing does not require a test license (MD13).
Import License Documents Required
- Valid Manufacturing License of the exporter
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification
- CE Certificate or equivalent regulatory approval
- Device Master File and Plant Master File
- Wholesale drug license (if applicable)
- Company Constitution documents
Timeline and Processing Duration
| License Type | Approximate Timeline |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| MD5 Manufacturing License (Class A) | 3 - 4 months (including test license and audit) |
| MD15 Import License | 5 - 6 months |
Understanding these timelines allows manufacturers and importers to plan product launches accordingly.
Government Fees and Costs for Hruby Fundus Lens Licensing
| License Type | Fees (INR) |
|---|---|
| MD5 License Application | Rs 5,000 per application + Rs 500 per product |
| MD15 Import License | Class A: USD 1000 per site + USD 50 per product |
Additional costs include fees for product testing, notified body audits, and any consultancy support.
Common Challenges and Solutions in Obtaining CDSCO License
- Incomplete Documentation: Prepare detailed Device Master File and Plant Master File upfront to avoid back-and-forth.
- Delays in Product Testing: Engage with CDSCO-approved testing labs early; plan at least 6 weeks for sample testing.
- Audit Non-compliance: Conduct pre-audit internal assessments and corrective actions to ensure smooth notified body audits.
- Query Resolution Delays: Assign a dedicated regulatory coordinator to respond promptly to CDSCO queries.
Leveraging our extensive experience, we help manufacturers navigate these hurdles effectively.
Expert Consultation and Support
With 25+ years of expertise and over 500 successful CDSCO license projects, we provide:
- Customized regulatory strategy for Class A ophthalmic devices
- Comprehensive document preparation and review
- Coordination with notified bodies and testing laboratories
- Timely follow-ups and query management
Our goal is to minimize your time-to-market and ensure full compliance.
Getting Started with Your CDSCO License Application for Hruby Fundus Lens
- Assess Your Product Classification: Confirm the Hruby fundus lens as Class A using the Medical Device Classification tool.
- Prepare Technical Documentation: Begin assembling your Device Master File and Plant Master File.
- Apply for Test License (Form MD13): Submit your application through the CDSCO MD Online Portal.
- Engage Testing Labs: Schedule product testing at CDSCO-recognized laboratories.
- Plan for Audit: Identify a notified body for your audit – refer to the list of notified bodies.
- Submit Manufacturing License Application (Form MD3): Once testing and audit are completed satisfactorily.
By following these precise steps and leveraging expert guidance, your Hruby fundus lens can gain timely regulatory approval and reach the Indian market with confidence.
For tailored support, reach out to our regulatory consulting team to kickstart your CDSCO licensing journey today.
