CDSCO License for Corneal resection holder

Comprehensive Guide to CDSCO Licensing for Corneal Resection Holder (Class B)

Corneal resection holders play a vital role in ophthalmic surgeries, specifically designed to securely hold donated corneal tissue during resection preparations for transplantation. As a Class B medical device under the CDSCO regulatory framework, obtaining the appropriate license is crucial for manufacturers aiming to market this device in India. With over 25 years of experience assisting 500+ companies in navigating CDSCO regulations, we provide a detailed roadmap to help you secure your manufacturing or import license efficiently.

CDSCO Regulatory Framework for Corneal Resection Holders

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Following the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, the corneal resection holder is classified as a Class B device under ophthalmology. This classification mandates compliance with specific licensing and quality management requirements before manufacturing or import.

The regulatory framework includes:

• Risk-based device classification
• Licensing by State or Central Authorities
• Mandatory product testing in government-approved labs
• Quality management system adherence (ISO 13485:2016)
• Audits by notified bodies or CDSCO inspectors

Understanding these elements is key to a successful application.

Risk Classification and License Requirements for Corneal Resection Holder

The corneal resection holder is categorized as a Class B device—a low to moderate risk classification. According to CDSCO norms, Class B devices require an MD5 manufacturing license issued by the State Licensing Authority. The licensing process involves:

• Obtaining a test license (Form MD13)
• Product testing at government-approved labs
• Documentation and technical file preparation
• Application submission (Form MD3)
• Audit by a notified body
• Resolution of any audit or authority queries

For importers, an MD15 import license from the Central Licensing Authority is mandatory, involving stringent documentation and fees.

Manufacturing License Process (MD5) for Corneal Resection Holder

Step 1: Obtain Test License (Form MD13)

Before applying for the manufacturing license, manufacturers must secure a test license valid for 6 months. This allows the corneal resection holder to undergo mandatory testing at CDSCO-approved labs. The test license typically takes 1.5 to 2 months to process.

Step 2: Product Testing

The next step involves submitting the device samples to government-recognized testing laboratories specializing in ophthalmic devices. Comprehensive testing ensures compliance with Indian standards and the Essential Principles checklist.

Step 3: Documentation Preparation

Simultaneously, prepare crucial documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Quality Management System (QMS) documentation, and product labeling files.

Step 4: Application Submission (Form MD3)

Submit the manufacturing license application for the corneal resection holder via the CDSCO MD Online Portal using Form MD3.

Step 5: Audit by Notified Body

Coordinate with a notified body from the CDSCO list for a comprehensive audit of your manufacturing facility and quality systems.

Step 6: Query Resolution and License Grant

Address any queries raised by the notified body or State Licensing Authority promptly. Upon satisfactory compliance, the manufacturing license (Form MD5) is granted.

For a detailed insight, refer to our MD5 License Guide.

Manufacturing License Documents Required for Corneal Resection Holder

To ensure smooth processing, prepare the following documents meticulously:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and qualifications of technical and managerial staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, materials, and manufacturing process (Device Master File guide)
• Plant Master File (PMF) documenting facility layout, equipment, and utilities (Plant Master File guide)
• Essential Principles Checklist certifying compliance with Indian regulations
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management resource)
• Test Reports from CDSCO-approved testing labs (Testing Laboratories list)
• Product labels, packaging, and Instructions for Use (IFU)
• Quality Management System (QMS) documentation aligned with ISO 13485:2016

Import License Process (MD15) for Corneal Resection Holder

Importers of corneal resection holders must apply for an MD15 import license through the Central Licensing Authority. Unlike manufacturing licenses, no test license is required. The process includes:

• Document preparation with emphasis on manufacturing license, CE certificate, ISO 13485:2016 certification, Free Sale Certificate, Device and Plant Master Files
• Submission of the application via CDSCO MD Online Portal using Form MD14
• Query resolution with the authorities
• License grant (Form MD15)

Refer to our Import License Guide for comprehensive assistance.

Import License Documents Required

• Valid Manufacturing License for the device from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

Import licenses (MD15) generally take 5 to 6 months due to central authority processing.

Government Fees and Costs

For manufacturing the corneal resection holder (Class B device), fees are as follows:

• Test License (MD13): Typically included in application fees
• Manufacturing License (MD5): Rs 5,000 per application plus Rs 500 per product

Additional costs include testing fees at government labs (variable), notified body audit fees (dependent on body), and internal costs for document preparation and QMS implementation.

For import licenses (MD15), fees are higher, with Class B devices attracting Rs 2,000 per site and Rs 1,000 per product.

Common Challenges and Solutions

Challenge 1: Delays in Test License Approval Solution: Submit a complete and error-free application with all supporting documents. Engage early with CDSCO officials for clarifications.

Challenge 2: Product Testing Failures or Delays Solution: Select reputable government-approved labs and conduct pre-testing internally to ensure compliance.

Challenge 3: Incomplete Documentation Leading to Queries Solution: Utilize detailed checklists and expert consulting services to prepare robust DMF, PMF, and Risk Management Files.

Challenge 4: Audit Non-compliance Solution: Conduct internal audits and gap assessments before notified body visits. Maintain ISO 13485:2016 certification rigorously.

Expert Consultation and Support

With over 25 years of experience assisting more than 500 medical device companies, we offer end-to-end support for CDSCO license applications. From documentation preparation to liaising with CDSCO authorities, our experts ensure your corneal resection holder manufacturing or import license is granted smoothly and efficiently.

Our services include:

• Gap analysis and compliance audits
• Detailed guidance on DMF and PMF preparation
• Regulatory strategy and timeline management
• Training on risk management and QMS implementation
• Support during notified body audits and query resolution

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your corneal resection holder is Class B under CDSCO.

2. Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.

3. Arrange Product Testing: Coordinate with CDSCO-approved labs listed here.

4. Prepare Documentation: Develop Device Master File, Plant Master File, Risk Management File, and QMS per ISO 13485:2016.

5. Engage a Notified Body: Select from the notified bodies for audit as per the official list.

6. Submit Manufacturing License Application: File Form MD3 for MD5 license on the CDSCO portal.

7. Prepare for Audit and Query Resolution: Conduct internal readiness checks and respond promptly to authority queries.

8. Obtain License and Commence Manufacturing: Upon approval, receive Form MD5 license and begin compliant manufacturing.

Embarking on this path with expert guidance significantly reduces risks of delays or rejections. Contact us today to leverage our expertise and ensure your corneal resection holder reaches the Indian market compliant and timely.