CDSCO License for Eye irrigation shield
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 device intended to be used with an eye irrigation kit/system to direct irrigation solution to the surface of the eye and allow the solution to gently lavage the surface of the eye.
Comprehensive Guide to CDSCO Licensing for Eye Irrigation Shield (Class A Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having supported more than 500 medical device companies, we understand the nuances of navigating India's CDSCO licensing landscape. The Eye Irrigation Shield, classified as a Class A medical device under ophthalmology, requires a meticulously managed regulatory pathway to ensure market entry compliance. This guide outlines every step, timeline, cost, and document requirement specific to this device.
Understanding the Eye Irrigation Shield and Its Regulatory Importance
The Eye Irrigation Shield is a critical accessory intended to direct irrigation solutions gently over the eye's surface, typically used alongside eye irrigation kits. Classified under ophthalmology and notified by CDSCO under Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, this device falls under the lowest risk Class A category. Despite its low-risk classification, obtaining the correct manufacturing or import license is essential for legal sale and distribution in India.
CDSCO Regulatory Framework for Class A Ophthalmic Devices
The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. For Class A devices like the Eye Irrigation Shield, the licensing authority is the State Licensing Authority, and the licensing process is governed under the MD5 license category. The following regulatory framework applies:
- Device Classification: Class A (low risk)
- License Type: MD5 Manufacturing License (Form MD3)
- Authority: State Licensing Authority
- Notification Reference: Fts No. 29/MiscJO3/2020-DC (187)
For further details on classification, you may refer to the Medical Device Classification guide.
Risk Classification and License Requirements for Eye Irrigation Shield
Being Class A, the Eye Irrigation Shield requires:
- Test License (Form MD13): Mandatory initial step to allow testing of the device.
- Product Testing: Conducted at CDSCO-approved government laboratories.
- Manufacturing License (MD5): Final license to manufacture and market the device in India.
This tiered approach ensures both safety and compliance without the extensive regulatory burden placed on higher-risk devices.
Detailed Manufacturing License Process (MD5) for Eye Irrigation Shield
The entire process from test license to final MD5 license typically spans 3 to 4 months. Here is the stepwise breakdown:
- Application for Test License (Form MD13): Submit through the CDSCO MD Online Portal. Processing takes approximately 6-8 weeks.
- Product Testing: Once the test license is granted, send samples to a notified testing laboratory. You can find the list of CDSCO-approved testing laboratories here.
- Documentation Preparation: Concurrently prepare required documents including Device Master File, Plant Master File, and Risk Management File.
- Application for Manufacturing License (Form MD3): Submit after satisfactory test reports.
- Audit by Notified Body: Arrange an audit with a notified body certified for Class A devices. The Notified Bodies List helps you identify authorized auditors.
- Resolution of Queries: Address any observations from the audit or CDSCO during review.
- Grant of MD5 License (Form MD5): Upon successful review and audit, the license is granted.
Manufacturing License Documents Required for Eye Irrigation Shield
For a seamless application, ensure you have the following documents:
- Company Constitution: Incorporation certificate, partnership deed, or equivalent
- Proof of Premises Ownership or Lease Agreement: Legal documents verifying manufacturing site
- Technical Staff Credentials: Qualifications and experience of key personnel
- Fire and Pollution NOCs: Compliance certificates from local authorities
- Device Master File (DMF): Detailed device description, design, and development data (see our Device Master File guide)
- Plant Master File (PMF): Information about manufacturing processes and quality systems (Plant Master File guide)
- Essential Principles Checklist: Compliance with safety and performance standards
- Risk Management File: Risk analysis and mitigation strategies (Risk Management insights)
- Test Reports: From CDSCO-approved laboratories
- Labels and Instructions for Use (IFU): Device labeling and user instructions
- Quality Management System (QMS) Documents: SOPs, CAPA, internal audits, etc.
Import License Process (MD15) for Eye Irrigation Shield
If you are an importer rather than a manufacturer, you must apply for an MD15 license governed by the Central Licensing Authority. The process takes about 5 to 6 months and involves:
- Document preparation including manufacturing license of the overseas manufacturer
- Submission of application on Form MD14 via the CDSCO MD Online Portal
- Query resolution
- Final grant of MD15 license
Documents include:
- Manufacturer’s License
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master and Plant Master Files
- Wholesale License
- Company Constitution
Timeline and Processing Duration for Eye Irrigation Shield Licensing
| Step | Approximate Duration |
|---|---|
| Test License (MD13) | 6 to 8 weeks |
| Product Testing | 3 to 4 weeks |
| Documentation Preparation | Concurrent |
| Manufacturing License (MD5) | 6 to 8 weeks |
| Audit and Query Resolution | 3 to 4 weeks |
Total: Approximately 3 to 4 months from start to finish.
Government Fees and Costs for MD5 License
- Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
Additional costs include:
- Testing laboratory charges (variable, typically Rs 30,000 to Rs 50,000 per product)
- Notified body audit fees (varies by body and scope)
- Documentation preparation and consultancy fees (if outsourced)
Common Challenges and Solutions
- Delayed Test Reports: Plan early sample submission and select notified labs with shorter turnaround times.
- Incomplete Documentation: Use a checklist aligned with CDSCO requirements to avoid rejections.
- Audit Non-compliance: Pre-audit your facility and QMS to ensure readiness.
- Query Management: Respond promptly and comprehensively to CDSCO queries to avoid processing delays.
Expert Consultation and Support
Navigating CDSCO regulations demands meticulous planning and execution. Our expertise has helped over 500 companies achieve timely approvals. We offer:
- End-to-end regulatory consulting
- Documentation drafting and review
- Audit preparation and liaison with notified bodies
- Training on compliance and QMS implementation
Getting Started with Your CDSCO License Application for Eye Irrigation Shield
- Register on the CDSCO MD Online Portal.
- Initiate your Test License application (Form MD13) promptly to save time.
- Engage with a notified testing laboratory early for sample testing schedules.
- Prepare your Device Master File and Plant Master File with care—these are critical for audit success.
- Schedule a notified body audit as soon as test reports are available.
- Address audit observations swiftly to prevent delays.
By following these tailored steps, manufacturers and importers of the Eye Irrigation Shield can confidently navigate the CDSCO licensing process, ensuring compliance and timely market access in India.
For detailed guidance on the MD5 license process, consult our MD5 License Guide.
Embark on your regulatory journey with clarity and confidence—reach out to us for personalized support and expert consultancy.
