CDSCO License for Ophthalmic excimer laser system
Medical Device Information
Intended Use
A laser device assembly intended for corneal ablation and other ophthalmologic procedures.
Comprehensive Guide to CDSCO Licensing for Ophthalmic Excimer Laser Systems (Class C)
As specialists with over 25 years of experience in medical device regulatory affairs, we have successfully guided more than 500 companies in obtaining CDSCO licenses for advanced devices like the Ophthalmic Excimer Laser System. This Class C medical device, designed for corneal ablation and various ophthalmologic procedures, requires strict adherence to India's regulatory framework to ensure safety, efficacy, and market access.
Understanding Your Ophthalmic Excimer Laser System and Its Regulatory Importance
The ophthalmic excimer laser system is a sophisticated laser assembly used primarily for corneal reshaping—critical in treating refractive errors and other eye conditions. Given its direct interaction with delicate ocular tissues and potential patient risk, the device is classified as Class C under CDSCO’s risk-based classification system. This classification mandates a centralized regulatory approach via the CDSCO Central Licensing Authority.
CDSCO Regulatory Framework for Ophthalmic Excimer Laser Systems
The regulatory pathway for this device involves multiple key steps, including product testing, documentation, audits, and licensing by CDSCO. Your device’s inclusion under Notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021 underscores its recognition and regulation under the Ministry of Health and Family Welfare.
Risk Classification and License Requirements for Class C Devices
Class C devices like the ophthalmic excimer laser system require an MD9 Manufacturing License and an MD15 Import License if you plan to import into India. The MD9 license is granted by the CDSCO Central Licensing Authority and involves a stringent application process including product testing, audit, and technical documentation review.
Manufacturing License Process (MD9) for Ophthalmic Excimer Laser Systems
The MD9 license application process is detailed and can span 4 to 5 months. Here's a practical workflow:
Test License (MD13): Apply for a test license on Form MD13. This preliminary license allows you to conduct product testing and typically takes 1.5 to 2 months for approval.
Product Testing: Get your ophthalmic excimer laser system tested at one of the government-approved testing laboratories. You can check the list of CDSCO-approved testing labs to select a suitable facility.
Document Preparation: Compile your comprehensive technical dossier, including Device Master File and Plant Master File, which are critical for compliance and audit readiness. Our Device Master File guide and Plant Master File guide provide actionable templates and tips.
Application Submission: Submit your MD9 application through the CDSCO MD Online Portal. The application is made on Form MD7.
Audit: CDSCO inspectors will conduct an on-site audit evaluating your manufacturing facility, quality management system, and compliance with the Essential Principles checklist.
Queries and Resolution: Address any queries raised by the department or inspectors promptly to avoid delays.
Grant of License: Upon satisfactory compliance, the CDSCO will grant the license on Form MD9.
Manufacturing License Documents Required
For a Class C device such as the ophthalmic excimer laser system, the following documents are essential:
- Company Constitution documents
- Proof of ownership or lease of manufacturing premises
- Qualification and experience documents of technical staff
- Fire and Pollution NOCs
- Device Master File (DMF)
- Plant Master File (PMF)
- Essential Principles Compliance Checklist
- Risk Management File adhering to ISO 14971 standards (our Risk Management guide can assist)
- Government-approved Test Reports
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents (preferably ISO 13485:2016 certified)
Import License Process (MD15) for Ophthalmic Excimer Laser Systems
If you plan to import the ophthalmic excimer laser system, an MD15 Import License is mandatory. The typical timeline is 5 to 6 months. Unlike the manufacturing license, no test license is required first, but comprehensive documentation is critical.
The steps include:
Document Compilation: Prepare the complete dossier, including your manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE certificate (if applicable), Device and Plant Master Files, and Wholesale Drug License.
Application Submission: File your application on the CDSCO MD Online Portal using Form MD14.
Queries and Clarifications: Promptly respond to any CDSCO queries.
Grant of License: After thorough review, CDSCO issues the MD15 license.
Import License Documents Required
- Valid Manufacturing License (MD9 or equivalent)
- Free Sale Certificate from exporting country
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| License Type | Timeline (Approx.) | Key Steps |
|---|---|---|
| MD9 (Manufacturing) | 4-5 months | Test license (1.5-2 months), testing, audit, queries, grant |
| MD15 (Import) | 5-6 months | Document review, queries, grant license |
Government Fees and Costs
For a Class C device like the ophthalmic excimer laser system, the fees are as follows:
MD9 Manufacturing License:
- Application Fee: INR 50,000
- Per Product Fee: INR 1,000
MD15 Import License:
- Site Fee: USD 3,000
- Per Product Fee: USD 1,500
Fees are payable online via the CDSCO portal during application submission.
Common Challenges and Solutions
Challenge 1: Delays in product testing due to lab backlogs.
- Solution: Pre-book testing slots early and select labs with shorter turnaround times from the CDSCO-approved testing laboratories.
Challenge 2: Incomplete or non-compliant documentation.
- Solution: Use comprehensive checklists and templates from our Device Master File guide and ensure your QMS aligns with ISO 13485:2016.
Challenge 3: Audit non-conformities.
- Solution: Conduct internal mock audits before official inspections and maintain all records meticulously.
Expert Consultation and Support
Navigating the CDSCO licensing landscape for Class C ophthalmic devices demands detailed knowledge and experience. Our expert team has supported over 500 companies in obtaining timely approvals. We offer tailored consulting to optimize your application, prepare audit documents, and resolve regulatory queries efficiently.
Getting Started with Your CDSCO License Application
To initiate your licensing journey:
Assess Device Classification: Confirm your device classification and regulatory pathway using our detailed Medical Device Classification resource.
Prepare Documentation: Start compiling your Device and Plant Master Files, risk management files, and QMS documentation.
Apply for Test License: Submit your MD13 application for test license through the CDSCO MD Online Portal.
Select Testing Lab: Choose an appropriate CDSCO-approved testing laboratory early to avoid delays.
Engage Notified Bodies: For the audit, refer to the list of notified bodies authorized for Class C device audits.
Plan Timeline: Allocate at least 4-5 months for manufacturing license approval and 5-6 months if importing.
Embarking on your CDSCO licensing process for the ophthalmic excimer laser system requires meticulous planning, but with our extensive experience and resources, you can confidently achieve compliance and market entry in India. Reach out to us for personalized support and to accelerate your regulatory approval.
