CDSCO License for Corneal marker

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

Introduction: Understanding Corneal Markers and Their Regulatory Importance

A Corneal Marker is a specialized manual instrument designed to imprint, indent, or incise corneal tissue during ophthalmic surgeries. Given its direct application to delicate eye tissue, ensuring the highest standards of safety and efficacy is paramount. In India, the Central Drugs Standard Control Organization (CDSCO) regulates such medical devices to safeguard public health. Navigating the CDSCO licensing process is crucial for manufacturers and importers seeking to market Corneal Markers in India, especially considering its classification as a Class B device under ophthalmology.

With over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we provide you a detailed roadmap to streamline your regulatory journey for Corneal Markers.

CDSCO Regulatory Framework for Corneal Markers

Corneal Markers fall under the ophthalmology category and are notified under Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021. As a Class B device, it is considered a low to moderate risk device requiring compliance with India's medical device rules, 2017.

The regulatory requirements include manufacturing or import licensing, quality management system adherence (ISO 13485), testing from CDSCO-approved labs, and compliance with essential principles.

Submit your applications and track progress through the CDSCO MD Online Portal.

Risk Classification and License Requirements for Corneal Markers

According to the CDSCO classification, Corneal Markers are Class B devices. This means:

• License type: MD5 Manufacturing License (for Indian manufacturers)
• Licensing authority: State Licensing Authority
• Application form: MD3 for manufacturing license
• Test license: MD13 is mandatory before applying for the manufacturing license

Manufacturers must obtain a Test License on Form MD13, conduct product testing at CDSCO-approved testing laboratories, and then apply for the MD5 license.

For detailed device classification, visit our Medical Device Classification guide.

Manufacturing License Process for Corneal Marker (MD5 License)

The MD5 license process for Class B devices like Corneal Markers involves several sequential steps:

1. Apply for Test License (Form MD13): This preliminary license allows you to manufacture and test the Corneal Marker. Processing time is approximately 1.5 to 2 months.

2. Product Testing: Conduct product testing at CDSCO-approved laboratories to validate safety and performance. Refer to the Testing Laboratories list for authorized labs.

3. Prepare Documentation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality system records.

4. Submit MD5 License Application (Form MD3): Upload all required documents and test reports via the CDSCO MD Online Portal.

5. Audit by Notified Body: A CDSCO-approved notified body conducts a thorough audit of your manufacturing facility and quality systems. Check the Notified Bodies List.

6. Resolve Queries: Address any observations or queries raised by the notified body or CDSCO licensing authority.

7. Grant of License: Upon successful compliance, the MD5 license will be issued.

The entire process typically takes 3 to 4 months from test license application to final license grant.

For a step-by-step walkthrough, see our MD5 License Guide.

Manufacturing License Documents Required for Corneal Marker

Accurate and complete documentation is critical for CDSCO approval. For Corneal Markers, you will need:

• Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association
• Proof of Ownership or Lease Agreement: For manufacturing premises
• Technical Staff Details: Qualification and experience certificates of key personnel
• Fire and Pollution NOCs: From local authorities
• Device Master File (DMF): Detailed device description, specifications, design, manufacturing process, and risk analysis. Our Device Master File guide provides comprehensive insights.
• Plant Master File (PMF): Details of manufacturing environment, equipment, quality systems. See our Plant Master File guide.
• Essential Principles Checklist: Compliance with safety and performance standards
• Risk Management File: Risk analysis and mitigation plans aligned with ISO 14971. Learn more about Risk Management.
• Test Reports: From CDSCO-approved laboratories
• Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements
• Quality Management System Documents: ISO 13485 certification, SOPs, CAPA records

Attention to detail in document preparation can significantly reduce processing delays.

Import License Process for Corneal Marker (MD15 License)

For importers of Corneal Markers, an MD15 import license is mandatory. Unlike manufacturing licenses, the MD15 does not require a test license but demands comprehensive documentation.

The process includes:

1. Document Preparation: Assemble manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device Master File, Plant Master File, wholesale license, and company constitution.

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

3. Query Resolution: Engage proactively with CDSCO queries.

4. License Grant: Typically takes 5 to 6 months.

Refer to our detailed Import License Guide for comprehensive assistance.

Import License Documents Required

Importers must submit:

• Manufacturing License of the device from the country of origin
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale license
• Company Constitution documents

Ensuring all documents are current and authenticated can expedite approval.

Timeline and Processing Duration for Corneal Marker Licensing

Timelines may vary based on document quality, audit schedules, and query resolution speed.

Government Fees and Costs for Corneal Marker Licensing

• MD5 Manufacturing License:

  • Application fee: Rs 5,000 per application
  • Product fee: Rs 500 per product (per variant)

• MD15 Import License:

  • For Class B devices: $2,000 per site +$1,000 per product

Additional costs include testing fees at CDSCO-approved labs, notified body audit charges, and consultant fees if applicable.

Budgeting realistically for these expenses prevents surprises during the regulatory journey.

Common Challenges and Solutions in CDSCO Licensing for Corneal Markers

Challenge: Delays due to incomplete documentation or inadequate testing.

Solution: Early engagement with notified bodies and testing labs ensures clarity on requirements. Preparing detailed Device and Plant Master Files reduces back-and-forth.

Challenge: Audit non-compliance due to poor QMS implementation.

Solution: Implement ISO 13485-aligned QMS well before audit. Conduct mock audits to identify gaps.

Challenge: Extended query resolution timelines.

Solution: Assign a dedicated regulatory liaison to respond promptly and comprehensively to CDSCO queries.

Our extensive experience helps clients anticipate and mitigate these issues effectively.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, but with expert guidance, manufacturers and importers can streamline approvals. Our team has successfully supported over 500 companies with medical device registration, including ophthalmic devices like Corneal Markers.

We offer:

• Gap analysis and readiness assessment
• Documentation preparation and review
• Liaison with notified bodies and CDSCO authorities
• Training on regulatory compliance and QMS implementation

Engage with us early in your product development cycle for best outcomes.

Getting Started with Your CDSCO License Application for Corneal Marker

1. Classify your device: Confirm Corneal Marker as Class B under CDSCO guidelines.

2. Plan your testing: Identify government-approved testing laboratories and initiate test license (MD13) application.

3. Assemble documentation: Develop comprehensive Device Master File and Plant Master File, along with risk management and QMS documents.

4. Apply for Test License: File Form MD13 via the CDSCO MD Online Portal.

5. Schedule audits: Coordinate with notified bodies early to align audits with your license application timeline.

6. Maintain proactive communication: Monitor application status online and prepare to address queries promptly.

Starting with a clear roadmap and expert support increases your chances of swift, successful CDSCO licensing for your Corneal Marker, enabling timely access to the Indian ophthalmic device market.