CDSCO License for Scleral marker

Comprehensive Guide to CDSCO Licensing for Scleral Marker (Class B Ophthalmic Device)

As a manual instrument designed to indent or imprint the scleral surface during ophthalmic surgeries, the Scleral Marker is classified under Class B medical devices per Indian regulations. With over 25 years of experience assisting 500+ companies in navigating CDSCO certifications, we understand the critical steps and common challenges manufacturers and importers face in bringing ophthalmic devices like the Scleral Marker to the Indian market.

Understanding the CDSCO Regulatory Framework for Scleral Markers

Under the Ministry of Health and Family Welfare, the Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Following the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, the Scleral Marker falls under Class B, indicating a low to moderate risk category. This classification influences the licensing pathway, documentation, and audit requirements.

Risk Classification and License Requirements for Class B Devices

Class B devices, including the Scleral Marker, require a manufacturing license under MD5, issued by the State Licensing Authority. This process is distinct from higher-risk Class C & D devices, which fall under MD9 and central licensing.

Key Points for Class B Scleral Markers:

• License Type: MD5 Manufacturing License
• Risk Class: B (Low to Moderate Risk)
• Licensing Authority: State Licensing Authority
• Total Processing Time: Approximately 3–4 months
• Fees: Rs 5,000 per application + Rs 500 per product

For manufacturers planning to import Scleral Markers, an MD15 import license is necessary, governed by the Central Licensing Authority.

Manufacturing License Process (MD5) for Scleral Marker

The MD5 license process involves several sequential steps:

1. Test License Application (Form MD13): Before manufacturing license application, companies must obtain a test license. This enables limited production for testing.
2. Product Testing: The Scleral Marker must be tested at government-approved laboratories to ensure compliance with applicable standards. Refer to the CDSCO Testing Laboratories list for approved facilities.
3. Document Preparation: Detailed compilation of technical and quality documents.
4. Manufacturing License Application (Form MD3): Submit the application along with documents via the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit of the manufacturing site is conducted by a notified body accredited by CDSCO. Check the list of notified bodies before scheduling.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of MD5 License: Upon satisfactory review, the state authority issues the license.

Manufacturing License Documents Required for Scleral Marker

To streamline your application, prepare the following documents:

• Company Constitution Documents: Incorporation certificate, memorandum, and articles of association.
• Proof of Premises Ownership or Lease Agreement: Confirming manufacturing site.
• Technical Staff Credentials: Qualifications and experience certificates of key personnel.
• Fire NOC and Pollution NOC: Compliance with safety and environmental norms.
• Device Master File (DMF): Detailed description of the Scleral Marker design, manufacturing process, and specifications. Learn more from our Device Master File guide.
• Plant Master File (PMF): Overview of manufacturing facility, equipment, and quality controls. Explore our Plant Master File guide.
• Essential Principles Checklist: Assurance of conformity to regulatory essential requirements.
• Risk Management File: Documented risk analysis and mitigation strategies. See our Risk Management resource.
• Test Reports: From CDSCO-approved labs validating device safety and performance.
• Labels and Instructions For Use (IFU): Drafts compliant with Indian requirements.
• Quality Management System (QMS) Documents: Evidence of adherence to ISO 13485 or equivalent.

Import License Process (MD15) for Scleral Marker

If importing Scleral Markers into India, an MD15 license from the Central Licensing Authority is mandatory. The process involves:

• Document Compilation: Including manufacturing license from country of origin, Free Sale Certificate, ISO 13485 certification, CE certificate, DMF, PMF, wholesale license, and company constitution.
• Application Submission: Via the CDSCO MD Online Portal.
• Review and Query Resolution: Responding to CDSCO queries promptly.
• License Grant: Typically within 5–6 months.

Import License Documents Required

• Valid manufacturing license of the Scleral Marker from the exporting country.
• Free Sale Certificate affirming marketing approval.
• ISO 13485:2016 certification.
• CE Certificate or equivalent international approvals.
• Device Master File & Plant Master File.
• Wholesale license for distribution in India.
• Company constitution and other corporate documents.

Timeline and Processing Duration

For the Scleral Marker as a Class B device, anticipate a total of roughly 3 to 4 months for manufacturing license completion, including the test license and audit phases.

Government Fees and Costs

For MD5 manufacturing license:

• Application Fee: Rs 5,000 per license application
• Product Fee: Rs 500 per product

Additional costs include:

• Testing laboratory fees (varies by lab and tests required)
• Notified body audit charges (can range from Rs 50,000 to Rs 1,00,000 depending on scope)

For import licenses (MD15), fees vary by device class and number of products, typically higher than manufacturing fees.

Common Challenges and Practical Solutions

Challenge 1: Delays in Test License and Product Testing

• Solution: Initiate test license application early and engage with CDSCO-approved labs beforehand to schedule testing.

Challenge 2: Incomplete or Inaccurate Documentation

• Solution: Use detailed checklists and consult expert resources such as our MD5 License Guide to ensure compliance.

Challenge 3: Audit Non-Conformities

• Solution: Prepare your facility according to notified body standards and conduct internal audits prior to official inspection.

Challenge 4: Query Resolution Delays

• Solution: Respond promptly and comprehensively to any queries raised by CDSCO or notified bodies to avoid processing delays.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for specialized devices like the Scleral Marker. Our consultancy has successfully guided over 500 companies through this process, offering:

• End-to-end support from document preparation to audit readiness.
• Strategic planning to meet timelines and regulatory compliance.
• Liaison services with licensing authorities and notified bodies.

Getting Started with Your CDSCO License Application for Scleral Marker

1. Assess Your Device Classification: Confirm the Scleral Marker is Class B as per Medical Device Classification.
2. Prepare Documentation: Begin compiling your Device Master File, Plant Master File, and QMS documentation.
3. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with CDSCO-approved labs early.
5. Plan for Audit: Engage a notified body from the official list to audit your manufacturing site.
6. Submit Manufacturing License Application (Form MD3): After test license and testing completion.
7. Prepare for Query Resolution: Assign a dedicated team member to respond to CDSCO queries efficiently.

Embarking on this journey with proactive planning and expert guidance will significantly enhance your chances of a smooth, timely approval for your Scleral Marker. Reach out to us for personalized assistance tailored to your device and business needs.

By prioritizing compliance and leveraging our extensive experience, you can confidently bring your ophthalmic devices to the Indian market while adhering to all regulatory requirements.