CDSCO License for Corneal epithelium perforator

Comprehensive Guide to CDSCO Licensing for Corneal Epithelium Perforator (Class B Medical Device)

As specialists with over 25 years of experience in regulatory consulting, we have assisted more than 500 manufacturers and importers in navigating the complex landscape of CDSCO licensing. This guide provides an in-depth look at obtaining the necessary approvals for the Corneal Epithelium Perforator, a Class B ophthalmic medical device used in corneal collagen crosslinking procedures.

Introduction: Understanding the Corneal Epithelium Perforator and Its Regulatory Importance

The Corneal Epithelium Perforator is designed to create micro-perforations in the corneal epithelial layer, enabling riboflavin penetration during treatment for corneal ectasia such as keratoconus. Given its direct application in ophthalmology and patient safety considerations, CDSCO mandates thorough evaluation and licensing before the device can be marketed or manufactured in India.

The device is notified under Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, underscoring its regulatory significance.

CDSCO Regulatory Framework for Corneal Epithelium Perforator

Under the Medical Device Rules, 2017, the Corneal Epithelium Perforator falls under Class B (low to moderate risk). The licensing and compliance process is overseen by the State Licensing Authority through the issuance of an MD5 license.

Manufacturers must adhere to the Quality Management System (QMS) aligned with ISO 13485:2016, ensure proper labeling, instructions for use (IFU), and perform mandatory testing in government-approved laboratories.

Risk Classification and License Requirements

• Risk Class: B (Low to Moderate Risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Issuing Authority: State Licensing Authority
• Total Processing Time: Approximately 3-4 months

The detailed classification and risk management strategies are essential. For clarity on classification, visit our Medical Device Classification resource.

Manufacturing License Process (MD5)

The process for obtaining the MD5 license for the Corneal Epithelium Perforator involves several sequential steps:

1. Test License Application (Form MD13): Initially, apply for a test license which takes about 1.5 to 2 months. This license allows manufacturing of samples for testing.
2. Product Testing: Samples must be tested in CDSCO-approved laboratories to validate safety and performance. Refer to the Testing Laboratories list.
3. Document Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and QMS records.
4. Application for Manufacturing License (Form MD3): Submit the application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit is conducted by a notified body to assess compliance. You can check the list of notified bodies authorized for Class B audits.
6. Resolution of Queries: Address any queries or corrective actions raised by CDSCO or the notified body promptly.
7. Grant of MD5 License: Upon successful completion, the license is issued in Form MD5.

For a detailed walkthrough, our MD5 License Guide provides actionable insights.

Manufacturing License Documents Required

Manufacturers must prepare and submit the following key documents:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement for Manufacturing Premises
• Details and Qualifications of Technical and Quality Personnel
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed device specifications and design controls. Learn more from our Device Master File Guide.
• Plant Master File (PMF): Manufacturing site details and quality systems. See our Plant Master File Guide.
• Essential Principles Checklist demonstrating compliance with safety and performance standards
• Risk Management File documenting hazard analysis and mitigation strategies (refer to Risk Management)
• Test Reports from government-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System documentation including SOPs, CAPA, and internal audit reports

Import License Process (MD15)

For importers of the Corneal Epithelium Perforator, an MD15 license issued by the Central Licensing Authority is mandatory. The process generally spans 5-6 months and involves:

• Preparation of requisite import documentation including manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), DMF and PMF, and wholesale license.
• Submission of application through the CDSCO MD Online Portal.
• Resolution of departmental queries.
• License grant under Form MD15.

Our Import License Guide elaborates on this process.

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale Drug License
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

*MD5 license timeline includes test license, product testing, audit, and license approval.

Government Fees and Costs

For the Corneal Epithelium Perforator (Class B), the fees are:

• MD5 License Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Note that additional costs include fees for testing laboratories, notified body audits, and consultancy services if engaged.

Common Challenges and Solutions

• Delay in Product Testing: To avoid bottlenecks, pre-select government-approved testing labs and initiate sample testing immediately after the test license is granted.
• Incomplete Documentation: Use comprehensive checklists and templates for DMF, PMF, and risk files. Our guides provide ready-to-use templates.
• Audit Non-Conformance: Prepare thoroughly for audits by conducting internal mock audits and ensuring QMS adherence.
• Query Resolution Delays: Assign a dedicated regulatory liaison to monitor and respond swiftly to CDSCO queries.

Expert Consultation and Support

Our extensive experience with over 500 successful CDSCO licensing projects positions us uniquely to guide you through this process efficiently. We provide:

• Tailored document preparation and review
• Coordination with notified bodies and testing labs
• Audit readiness training
• Query management and follow-up

Getting Started with Your CDSCO License Application

To initiate your CDSCO licensing journey for the Corneal Epithelium Perforator:

1. Register on the CDSCO MD Online Portal and familiarize yourself with the workflow.
2. Apply for the Test License (MD13) to begin sample production and testing.
3. Identify and engage a notified body early to schedule your audit.
4. Begin compiling all required documentation simultaneously to avoid delays.
5. Plan your internal QMS and risk management reviews in parallel with testing.

By following these steps and leveraging our expert insights, you can streamline your licensing process and confidently bring your Corneal Epithelium Perforator to the Indian market.

For personalized assistance or to discuss your project, please contact our regulatory consulting team.