CDSCO License for Contact Lens Inserter/Remover

Understanding Contact Lens Inserter/Remover Devices and Their Regulatory Importance

Contact Lens Inserter/Remover devices play a crucial role in ophthalmology by providing safe, hygienic, and user-friendly means to insert and remove contact lenses. Given their direct contact with the eye, regulatory oversight ensures these devices meet stringent safety and quality standards. In India, the Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of such medical devices to protect public health and facilitate market access.

We have supported over 500 manufacturers and importers in successfully navigating the CDSCO licensing process, and in this guide, we focus specifically on Contact Lens Inserter/Remover devices categorized as Class A medical devices under the ophthalmology category.

CDSCO Regulatory Framework for Contact Lens Inserter/Remover Devices

India’s regulatory framework classifies Contact Lens Inserter/Remover devices as Class A—low risk—under the Medical Device Rules, 2017, as notified in the Gazette Notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021. Compliance with these rules is mandatory for manufacturers and importers wishing to market these devices in India.

The licensing authority for Class A devices is the State Licensing Authority, and the applicable manufacturing license is the MD5 license (Form MD3 application). For importers, the MD15 import license applies.

Risk Classification and License Requirements for Contact Lens Inserter/Remover

• Risk Class: A (Low Risk)
• Regulatory Category: Ophthalmology
• License Type: MD5 Manufacturing License for manufacturers
• Regulatory Authority: State Licensing Authority

Class A devices require a manufacturing license (MD5) after obtaining a test license on Form MD13. The entire process—from test license application to final MD5 license grant—typically spans approximately 3 to 4 months.

Manufacturing License Process (MD5) for Contact Lens Inserter/Remover

1. Test License Application (Form MD13): You must first secure a test license to manufacture the device for testing purposes. This step generally takes 1.5 to 2 months.

2. Product Testing: Samples must be tested at CDSCO-approved laboratories to verify compliance with safety and quality standards.

3. Document Preparation: Prepare all required documentation, including technical files and quality system documents.

4. Application for MD5 License (Form MD3): Submit your application through the CDSCO MD Online Portal.

5. Audit by Notified Body: Coordinate an audit with a notified body listed here to verify compliance with manufacturing and quality requirements.

6. Resolution of Queries: Address any observations or queries raised by the regulatory authority or notified body promptly.

7. Grant of MD5 License: Upon satisfactory compliance, the State Licensing Authority will issue the manufacturing license in Form MD5.

Manufacturing License Documents Required for Contact Lens Inserter/Remover

The documentation package is critical for a smooth review process and must include:

• Company Constitution Documents: Incorporation certificate, partnership deed, or equivalent.
• Proof of Premises Ownership or Lease Agreement: Demonstrating legal rights to the manufacturing site.
• Technical Staff Qualifications: Details of qualified personnel responsible for manufacturing.
• Fire NOC and Pollution Control NOC: Certificates from relevant authorities.
• Device Master File: Comprehensive technical documentation of the device. Our Device Master File guide can help prepare this effectively.
• Plant Master File: Details of manufacturing facilities and processes. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist: Compliance checklist as per CDSCO guidelines.
• Risk Management File: Documentation demonstrating risk assessment and mitigation measures. See our Risk Management resource.
• Test Reports: Product test results from CDSCO-approved labs. A list of such Testing Laboratories is available.
• Labels and Instructions for Use (IFU): Drafts reflecting regulatory compliance.
• Quality Management System Documents: Evidence of ISO 13485 or equivalent QMS implementation.

Import License Process (MD15) for Contact Lens Inserter/Remover

For importers, the MD15 license is mandatory and is granted by the Central Licensing Authority. The process typically takes 5 to 6 months and involves:

• Document Compilation: Including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and technical documentation.
• Application Submission: File the application on the CDSCO MD Online Portal.
• Review and Query Resolution: Address any CDSCO queries promptly.

Notably, importers do not require a test license (MD13) but must ensure that their foreign manufacturers comply with Indian regulatory standards.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or Equivalent
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution Documents

Timeline and Processing Duration

Manufacturers should factor in the testing and audit durations when planning their market entry.

Government Fees and Costs

• Test License (MD13): Nominal fees as per state regulations.
• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product.
• MD15 Import License: Fees vary by class; for Class A devices, approximately $1,000 per site and$50 per product.

These fees are payable online via the CDSCO MD Online Portal.

Common Challenges and Solutions

• Delays in Document Preparation: Start early with document compilation and seek expert help for technical files.
• Testing Lab Backlogs: Schedule testing well in advance and select approved labs with shorter lead times.
• Audit Non-compliance: Conduct internal pre-audits to identify gaps before the notified body audit.
• Query Resolution Delays: Assign a dedicated regulatory coordinator to respond swiftly to CDSCO queries.

Our experience shows that proactive planning and thorough documentation significantly reduce licensing delays.

Expert Consultation and Support

Navigating CDSCO licensing for ophthalmic devices like Contact Lens Inserter/Remover requires specialized knowledge. Our 25+ years of regulatory consulting experience enable us to provide tailored support from test license application through audit facilitation and final license grant. We assist clients in meeting all technical and compliance requirements, ensuring a smooth and timely approval process.

Getting Started with Your CDSCO License Application for Contact Lens Inserter/Remover

1. Assess Device Classification: Confirm Class A status and licensing pathway.
2. Prepare Technical Documentation: Use our Device and Plant Master File guides to organize your files.
3. Apply for Test License (MD13): Submit online via the CDSCO MD Online Portal.
4. Coordinate Product Testing: Engage a CDSCO-approved testing laboratory early.
5. Plan for Audit: Identify and schedule audit with a notified body from the official list.
6. Compile Application for MD5 License: Ensure all documents and fees are in order.
7. Submit and Monitor Application: Track progress, respond to queries promptly.

Contact us to leverage our proven expertise and streamline your CDSCO licensing journey for Contact Lens Inserter/Remover devices, ensuring your ophthalmic device reaches the Indian market compliantly and efficiently.