CDSCO License for Eye valve
Medical Device Information
Intended Use
An implantable device designed to regulate the flow of fluid between the anterior chamber and the space around the conjunctiva of the eye by allowing flow when the pressure in the chamber is above a pre-set value.
Comprehensive Guide to CDSCO Licensing for Eye Valve Implant Devices (Class C)
As a trusted partner with over 25 years of experience assisting more than 500 companies in navigating the Indian regulatory landscape, we offer you expert insights on obtaining your CDSCO license for the Eye Valve implant device. This device, classified as Class C under CDSCO regulations, plays a critical role in ophthalmology by regulating fluid flow in the eye to manage intraocular pressure effectively.
Understanding the Eye Valve and Its Regulatory Importance
The Eye Valve is an implantable medical device intended to regulate fluid flow between the anterior chamber and the space around the conjunctiva, activating only when the pressure exceeds a preset threshold. Given its implantable nature and involvement with vital ocular structures, it carries a moderate to high risk, mandating stringent regulatory oversight to ensure patient safety and device efficacy.
In India, the Central Drugs Standard Control Organization (CDSCO) governs the licensing and regulation of medical devices like the Eye Valve. Compliance with their framework is essential for manufacturers and importers aiming to enter the Indian market.
CDSCO Regulatory Framework for Eye Valve Devices
The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, which classify devices based on risk and intended use. The Eye Valve falls under Class C due to its implantable nature and moderate risk profile.
For Class C devices, the manufacturing license is issued as an MD9 license (Application Form MD7) by the Central Licensing Authority. Similarly, importers must obtain the MD15 import license.
You can begin your application process conveniently by submitting all necessary documents through the official CDSCO MD Online Portal.
Risk Classification and License Requirements for Eye Valve
- Risk Class: C
- Device Type: Implantable ophthalmic medical device
- License Type for Manufacturing: MD9
- Authority: Central Licensing Authority, CDSCO
Due to the device’s risk classification, the MD9 license process includes a comprehensive evaluation comprising product testing, documentation audit, and on-site inspections.
Manufacturing License Process (MD9) for Eye Valve
The MD9 license process typically spans 4 to 5 months and involves several critical stages:
- Test License Application (Form MD13): Obtain a test license to produce and test the device batch. This takes approximately 1.5 to 2 months.
- Product Testing: Testing must be conducted in government-approved laboratories. For your convenience, refer to the list of CDSCO-approved testing laboratories.
- Document Preparation: Prepare detailed technical files, including Device Master File and Plant Master File.
- License Application (Form MD7): Submit your manufacturing license application through the CDSCO MD Online Portal.
- Audit and Inspection: CDSCO officials conduct an in-depth inspection of your manufacturing facility and documentation.
- Query Resolution: Address any queries raised by the department or auditors promptly.
- License Grant: Upon successful compliance, the MD9 license is issued.
Manufacturing License Documents Required for Eye Valve
Prepare the following to ensure a seamless application:
- Company Constitution (e.g., Memorandum of Association, Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Documents of Qualified Technical Staff and their Experience
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF): Detailed design, manufacturing process, and material specifications (Learn more about Device Master Files)
- Plant Master File (PMF): Information about your manufacturing facilities and quality systems (Guidance on Plant Master Files)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating compliance with ISO 14971 standards (Risk Management Implementation)
- Test Reports from CDSCO-approved laboratories
- Labels and Instructions for Use (IFU) complying with regulatory standards
- Quality Management System (QMS) Documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Eye Valve
For importers, the process to obtain an MD15 license requires:
- Preparation of comprehensive documentation including Manufacturing License, Free Sale Certificate from the country of origin, ISO 13485:2016, CE Certificate, Device Master and Plant Master Files
- Application on Form MD14 submitted via the CDSCO MD Online Portal
- Query resolution with the CDSCO
- License issuance within 5 to 6 months
Import License Documents Required
- Valid Manufacturing License (MD9 or equivalent) from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale license in India
- Company Constitution
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5-2 months |
| Product Testing | 1-2 months |
| Documentation Preparation | 2-3 weeks |
| Application Processing (MD9) | 1-1.5 months |
| Audit & Query Resolution | 3-4 weeks |
| Total Time | 4-5 months |
Government Fees and Costs
MD9 Manufacturing License:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
Test License (MD13): Usually included in the process fee
Import License (MD15): Varies by class and products; for Class C devices, typically around ₹3,000 per site and ₹1,500 per product
These fees are payable online through the CDSCO portal at the time of application submission.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage early with notified government labs and schedule testing promptly. Refer to the CDSCO Testing Laboratories list to select accredited facilities.
Challenge 2: Incomplete Documentation
- Solution: Utilize expert consultation to prepare detailed and compliant Device and Plant Master Files. Review our comprehensive Device Master File Guide and Plant Master File Guide for best practices.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal mock audits and ensure adherence to QMS and regulatory requirements before CDSCO inspection.
Expert Consultation and Support
With our vast experience, we provide tailored assistance to manufacturers and importers of ophthalmic devices like the Eye Valve. From documentation preparation to audit readiness and application submission, our consultancy accelerates your license approval process, minimizing delays and compliance risks.
Getting Started with Your CDSCO License Application for Eye Valve
- Assess Risk Classification: Confirm your device is Class C using the Medical Device Classification tool.
- Engage a Notified Testing Laboratory: Early coordination with labs speeds up the testing phase.
- Prepare Technical Documentation: Compile Device Master File, Plant Master File, Risk Management, and QMS documentation.
- Apply for Test License (MD13): Submit via the CDSCO MD Online Portal.
- Complete Product Testing: Obtain mandatory test reports.
- Submit MD9 License Application (Form MD7): Along with all supporting documents.
- Prepare for Audit: Address any preliminary gaps through internal audits.
- Respond to Queries Promptly: Expedite licensing by timely addressing CDSCO or auditor concerns.
Embarking on this process with clarity and expert guidance will smooth your path to market entry in India. Contact us today to leverage our 25+ years of regulatory expertise and ensure your Eye Valve device obtains timely CDSCO approval.
