CDSCO License for Corneal burr, rust ring removal

Comprehensive Guide to CDSCO Licensing for Corneal Burr, Rust Ring Removal Device (Class B Ophthalmology Device)

Introduction: Understanding the Corneal Burr and Its Regulatory Significance

The Corneal Burr, Rust Ring Removal device is a specialized ophthalmic tool designed for the gentle and effective removal of rust stains (rust rings) from the cornea following the extraction of ferrous foreign bodies. As a Class B medical device under CDSCO regulations, it carries a moderate risk level, necessitating stringent compliance to ensure patient safety and product efficacy.

Given the critical role this device plays in delicate eye procedures, regulatory approval by the Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or importing it into India. Navigating this regulatory landscape can be complex, but with over 25 years of experience and having supported 500+ companies, we provide you with detailed, practical guidance to secure your CDSCO license efficiently.

CDSCO Regulatory Framework for Corneal Burr (Class B Ophthalmic Device)

The CDSCO classifies medical devices based on risk, with Class B representing low to moderate risk devices. Your device falls under the ophthalmology category and is notified under Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.

For Class B devices, the MD5 license is required, which is issued by the State Licensing Authority. The licensing process is designed to ensure compliance with quality, safety, and performance standards as per the Medical Device Rules, 2017.

Risk Classification and License Requirements

• Device Name: Corneal Burr, Rust Ring Removal
• Risk Class: B (Low to moderate risk)
• Category: Ophthalmology
• Regulatory License: MD5 Manufacturing License (Form MD3)
• Issuing Authority: State Licensing Authority

This classification necessitates obtaining an MD5 license for domestic manufacturing. For importers, an MD15 license applies, which we cover later.

Manufacturing License Process (MD5 License)

The MD5 license approval involves several sequential steps:

1. Test License (Form MD13): Initially, you must apply for a test license to begin product testing and validation. This takes approximately 1.5 to 2 months.

2. Product Testing: Conduct testing of the Corneal Burr at government-approved laboratories to confirm compliance with applicable standards. Testing labs can be found on the CDSCO Testing Laboratories list.

3. Documentation Preparation: Compile all necessary documents including technical files, quality management system (QMS) documents, Device Master File, and Plant Master File.

4. Application Submission: Submit the manufacturing license application on Form MD3 through the CDSCO MD Online Portal.

5. Audit by Notified Body: Undergo an audit by a notified body approved for medical devices. Refer to the Notified Bodies List for MD5 Audit.

6. Queries Resolution: Respond promptly and comprehensively to any queries raised by the authorities or notified body.

7. License Grant: Upon successful audit and clearance, the MD5 license is granted on Form MD5.

The entire process typically spans 3 to 4 months, assuming timely compliance.

Manufacturing License Documents Required for Corneal Burr

To ensure a smooth and successful application, prepare the following documents:

• Company Constitution Documents: Incorporation certificate, partnership deed, or memorandum of association.
• Proof of Ownership or Lease of Manufacturing Premises: Utility bills, rent agreements.
• Technical Staff Details: Qualification and experience certificates of the personnel involved in manufacturing.
• Fire NOC and Pollution Control NOC: Obtained from local authorities.
• Device Master File (DMF): Detailed technical dossier on the Corneal Burr. Learn more from our Device Master File guide.
• Plant Master File: Details of the manufacturing site and processes. Our Plant Master File guide can assist you.
• Essential Principles Checklist: Declaration of conformity with Indian Medical Device Rules.
• Risk Management File: Evidence of implementation of risk management processes as per ISO 14971. More on Risk Management.
• Test Reports: From government-approved labs validating device safety and performance.
• Labels and Instructions for Use (IFU): Drafts showing compliance with labeling regulations.
• Quality Management System Documents: ISO 13485:2016 certificates, SOPs, and records.

Import License Process (MD15 License)

For manufacturers or distributors intending to import the Corneal Burr into India, obtaining an MD15 import license from the Central Licensing Authority is mandatory.

The process includes:

1. Document Preparation: Collect all essential documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE certificate, DMF, and Plant Master File.

2. Application Submission: File the application on Form MD14 via the CDSCO MD Online Portal.

3. Queries Resolution: Address any departmental queries promptly.

4. License Grant: After satisfactory review, the MD15 license is issued.

This process generally requires 5 to 6 months.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate (FSC) or equivalent
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

For your Class B Corneal Burr device, the fees are as follows:

• MD5 License:

  • Rs 5,000 per application
  • Rs 500 per product

• MD15 Import License:

  • $2,000 per site
  • $1,000 per product

Budget accordingly for testing, notified body audits, and professional consultancy fees if you choose expert assistance.

Common Challenges and Practical Solutions

• Delayed Test Reports: Plan testing well in advance and choose government-approved labs with good turnaround times.

• Incomplete Documentation: Use detailed checklists to ensure all documents, such as Device Master File and Risk Management File, are complete and compliant.

• Audit Non-compliance: Conduct internal pre-audit readiness assessments and engage experienced notified bodies listed on the CDSCO Notified Bodies List.

• Query Resolution Delays: Assign dedicated regulatory personnel or consultants to respond swiftly to CDSCO queries.

Expert Consultation and Support

With over 25 years in regulatory consulting, we have successfully guided 500+ companies through the nuances of CDSCO licensing. Our tailored services include:

• End-to-end documentation preparation
• Pre-audit readiness and gap analysis
• Liaison with CDSCO and notified bodies
• Product testing coordination
• Post-license compliance support

Our expertise reduces your approval timeline and minimizes costly rejections.

Getting Started with Your CDSCO License Application for Corneal Burr

Ready to enter the Indian market with your Corneal Burr device?

1. Determine Your Licensing Path: Manufacturing? Import? Or both?
2. Register on the CDSCO MD Online Portal: Initiate your application at the CDSCO MD Online Portal.
3. Prepare Test License Application: Secure your MD13 test license to begin product testing.
4. Schedule Product Testing: Engage government-approved labs early.
5. Compile Documentation: Utilize our Device Master File and Plant Master File guides to streamline document preparation.
6. Select a Notified Body: Identify an appropriate notified body for audit from the official list.
7. Submit Manufacturing License Application: After test license and testing, file Form MD3 for the MD5 license.

By following these actionable steps and leveraging expert support, you can confidently navigate the CDSCO licensing process for your Corneal Burr device. Contact us today to accelerate your journey towards regulatory approval and market access in India.