CDSCO License for Corneal burr, abrasion

Understanding the Corneal Burr, Abrasion and Its Regulatory Importance

The Corneal Burr, Abrasion is a specialized ophthalmic medical device designed primarily for delicate procedures such as polishing corneal scratches, treating the pterygium bed post-surgery, and abrading lid margin lesions. Given its direct use on sensitive eye tissue, regulatory oversight ensures both safety and efficacy for patients. For manufacturers and importers aiming to enter the Indian market, obtaining the correct CDSCO license is not just mandatory but critical for compliance and market access.

CDSCO Regulatory Framework for Corneal Burr, Abrasion (Class B Device)

Under Indian regulations, the Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing. The Corneal Burr falls under Class B risk classification according to the notified medical devices list (Notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021). Class B devices are considered low to moderate risk and are regulated by the State Licensing Authority via the MD5 manufacturing license process.

Risk Classification and License Requirements for Class B Ophthalmic Devices

Class B devices like the Corneal Burr require stringent quality and safety checks but benefit from a more streamlined regulatory path compared to higher classes. The license process includes obtaining a test license (MD13), performing product testing in government-approved labs, and an audit by a notified body. This ensures manufacturers meet the essential principles outlined by CDSCO and maintain high standards.

Manufacturing License Process (MD5) for Corneal Burr, Abrasion

At our consultancy, we have successfully guided over 500 companies through the MD5 licensing process. For the Corneal Burr, the process comprises the following steps:

1. Apply for Test License (Form MD13): This initial step takes approximately 1.5 to 2 months and allows you to legally manufacture the device for testing purposes.
2. Product Testing: Send samples to approved laboratories, such as those listed on the CDSCO Testing Laboratories portal, to obtain mandatory test reports.
3. Document Preparation: Compile the Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, Quality Management System documents, and other required paperwork.
4. Apply for Manufacturing License (Form MD3): Submit your application through the CDSCO MD Online Portal.
5. Audit by Notified Body: The notified body will conduct a thorough audit of your manufacturing facility and documentation. Check the list of notified bodies to select an authorized auditor.
6. Respond to Queries: Address any observations or queries from CDSCO or the notified body promptly to avoid delays.
7. Grant of MD5 License: Once all criteria are met, CDSCO issues the manufacturing license on Form MD5.

Manufacturing License Documents Required for Corneal Burr, Abrasion

Ensure the following documents are meticulously prepared and submitted:

• Company Constitution (Memorandum and Articles of Association)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – Our detailed Device Master File guide can assist you in preparation
• Plant Master File (PMF) – Refer to our Plant Master File guide
• Essential Principles Checklist demonstrating compliance
• Risk Management File per ISO 14971 (Risk Management resource)
• Test Reports from Government Approved Labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, ideally ISO 13485:2016 certification

Import License Process (MD15) for Corneal Burr, Abrasion

For importers, the process is managed by the Central Licensing Authority through the MD15 license. This process generally takes 5-6 months and includes:

• Preparation of necessary documents such as Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files
• Submission of application via Form MD14 on the CDSCO MD Online Portal
• Resolution of any regulatory queries
• Grant of MD15 Import License

Note: The import license process does not require a test license phase unlike the manufacturing license.

Timeline and Processing Duration

Government Fees and Costs

For a Class B device like the Corneal Burr, the government fees are as follows:

• Test License (MD13): Approximately Rs. 5000 (varies by state)
• Manufacturing License (MD5): Rs. 5000 per application + Rs. 500 per product category

Additional costs include:

• Fees for product testing at government-approved labs
• Notified body audit fees (varies by agency)
• Consultancy and documentation preparation (if outsourced)

Common Challenges and Practical Solutions

Challenge 1: Delay in Product Testing

• Solution: Engage with CDSCO-approved labs early. Maintain clear communication and submit samples in batches if possible.

Challenge 2: Incomplete Documentation

• Solution: Use comprehensive checklists like our Device Master File and Plant Master File guides to ensure completeness.

Challenge 3: Audit Non-Conformities

• Solution: Conduct internal mock audits before the notified body visit to identify gaps and train your staff accordingly.

Challenge 4: Queries from CDSCO Taking Time to Resolve

• Solution: Prepare detailed, evidence-backed responses with clear documentation to expedite query resolution.

Expert Consultation and Support

With over 25 years of experience and over 500 successful CDSCO license applications, we provide end-to-end support—from initial classification and gap analysis to document preparation, application filing, audit coordination, and post-approval compliance. Our tailored approach reduces regulatory risk and accelerates your time to market.

Getting Started with Your CDSCO License Application for Corneal Burr, Abrasion

1. Confirm your device classification by consulting the Medical Device Classification resource to validate the Class B status.
2. Register on the CDSCO MD Online Portal to create your manufacturer/importer account.
3. Prepare your test license application (Form MD13) to initiate the process.
4. Identify and engage with a notified body early to schedule your audit.
5. Start compiling your Device Master and Plant Master Files using expert guides.

Embarking on the CDSCO licensing journey can seem complex, but with our proven roadmap and expert guidance, your Corneal Burr, Abrasion device can gain regulatory approval efficiently and compliantly, opening the door to the lucrative Indian ophthalmology market.