CDSCO License for Ophthalmic Viscosurgical Device
Medical Device Information
Intended Use
Viscoelastic solution for Intraocular use during eye surgery.
Introduction to Ophthalmic Viscosurgical Devices and Regulatory Importance
Ophthalmic Viscosurgical Devices (OVDs) are specialized viscoelastic solutions used intraocularly during delicate eye surgeries to maintain eye structure and protect ocular tissues. Given their critical application in ophthalmology, these devices fall under Class C risk category as per CDSCO regulations, indicating a moderate to high risk to patient safety if not properly manufactured or controlled.
For manufacturers and importers aiming to enter the Indian market, obtaining the appropriate CDSCO licenses is not just a regulatory formality but a vital step to ensure compliance, quality, and patient safety. With over 25 years of experience and having successfully assisted 500+ companies, we understand the nuances and practical challenges involved in acquiring these licenses for Class C devices like OVDs.
CDSCO Regulatory Framework for Ophthalmic Viscosurgical Devices
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Medical Device Rules, 2017. OVDs, classified as Class C, require rigorous oversight. The manufacturing license is issued centrally via the MD9 license, while importers need the MD15 license. Both licenses ensure that the device meets stringent quality, safety, and efficacy standards.
The notified notification for this device category is 29/Misc/3/2017-DC (18), dated 16.08.2018, officially listing OVDs under Class C, Disposable Hypodermic Syringes category.
Risk Classification and License Requirements
- Risk Class: C (Moderate to High Risk)
- License for Manufacturing: MD9 (Application Form MD7)
- License for Import: MD15 (Application Form MD14)
- Regulatory Authority: Central Licensing Authority (CDSCO HQ)
Class C devices demand comprehensive technical documentation, testing, and audits by CDSCO authorities to ensure compliance with Indian and international standards.
Manufacturing License Process for MD9 (Class C Devices)
- Test License Application (Form MD13): Mandatory before full manufacturing license. Duration: 1.5 to 2 months.
- Product Testing: Conducted at CDSCO-recognized laboratories. Find approved labs on the Testing Laboratories list.
- Documentation Preparation: Includes Device Master File, Plant Master File, QMS, risk management, and more.
- License Application (Form MD7): Submit via the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: Physical and document verification.
- Query Resolution: Address any observations or deficiencies raised.
- Grant of MD9 License (Form MD9): Upon satisfactory compliance.
Total processing time is approximately 4 to 5 months from start to finish.
Manufacturing License Documents Required
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details of Technical Staff Qualifications and Experience
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File: Detailed technical specifications, formulation, and manufacturing process. Our Device Master File guide provides comprehensive insights.
- Plant Master File: Manufacturing facility details and quality systems. Check our Plant Master File guide for preparation tips.
- Essential Principles Checklist (Compliance with Indian Medical Device Rules)
- Risk Management File aligned with ISO 14971 standards. Learn more about Medical Device Risk Management.
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 compliance)
Import License Process for MD15 (Class C Devices)
- Document Preparation: Ensure all required credentials and certificates (including manufacturing license, Free Sale Certificate, ISO 13485, CE certificate) are in place.
- Application Submission: File Form MD14 through the CDSCO MD Online Portal.
- Query Handling: Promptly respond to any CDSCO queries.
- License Grant: Upon successful evaluation, MD15 license is issued.
The import license process typically takes 5 to 6 months.
Import License Documents Required
- Valid Manufacturing License (MD9 or equivalent from country of origin)
- Free Sale Certificate from country of origin
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License for distribution within India
- Company Constitution
Timeline and Processing Duration
| License Type | Processing Time | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5 to 2 months | Product testing and initial approval |
| Manufacturing License (MD9) | 4 to 5 months (including test license) | Audit, documentation, query resolution |
| Import License (MD15) | 5 to 6 months | Document evaluation and final approval |
Planning your regulatory timeline in advance allows for efficient market entry without costly delays.
Government Fees and Costs
- MD9 Manufacturing License:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
- MD15 Import License:
- Class C Devices: $3,000 per site
- Per Product Fee: $1,500
Additional costs include product testing fees, audit fees (if applicable), and consultancy charges if professional support is engaged.
Common Challenges and Solutions
- Delayed Test Reports: Plan ahead and choose CDSCO-approved labs with proven turnaround times. Refer to the Testing Laboratories list.
- Incomplete Documentation: Use detailed checklists and expert consultation to ensure completeness.
- Audit Non-Conformities: Conduct internal pre-audits and training for technical staff.
- Query Resolution Delays: Assign dedicated personnel to monitor and respond promptly.
Our extensive experience has helped clients overcome these hurdles efficiently.
Expert Consultation and Support
Navigating CDSCO licensing for Class C devices like Ophthalmic Viscosurgical Devices requires meticulous attention to detail and regulatory know-how. We provide end-to-end assistance including document preparation, liaison with CDSCO, audit readiness, and post-approval compliance.
Partnering with seasoned consultants significantly reduces risks of rejection and expedites approvals.
Getting Started with Your CDSCO License Application
- Classify Your Device: Confirm classification as Class C using the Medical Device Classification resource.
- Prepare Preliminary Documents: Gather company registrations, facility proofs, and technical staff credentials.
- Initiate Test License Application: Apply for MD13 on the CDSCO MD Online Portal.
- Coordinate Product Testing: Engage with notified labs early.
- Develop Technical Files: Compile Device Master File, Plant Master File, and Risk Management documentation.
- Plan for Audit: Review the list of notified bodies and prepare accordingly.
- Submit Manufacturing License Application (MD7): After successful testing.
For importers, focus on assembling the complete dossier and submitting Form MD14.
Our expert team is ready to guide you through each step, ensuring your Ophthalmic Viscosurgical Device reaches the Indian market seamlessly and compliantly.
For personalized assistance or detailed queries, feel free to connect with our regulatory consultants who have transformed the market entry experience for hundreds of medical device companies.
