CDSCO License for Eye pad

Comprehensive Guide to CDSCO Licensing for Eye Pads (Class A Medical Device)

Eye pads, classified as Class A medical devices under the Indian regulatory framework, are sterile, cushion-like devices designed to protect the eye or absorb eye secretions. Given their critical role in ophthalmology, obtaining proper licensing from the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers before marketing in India. With over 25 years of experience assisting 500+ companies, we provide detailed, actionable insights to help you successfully navigate the CDSCO licensing process for eye pads.

CDSCO Regulatory Framework for Eye Pads

Eye pads fall under the category of ophthalmology devices with notification number Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021. As a Class A device, eye pads are considered low risk but still require strict adherence to regulatory requirements under the Medical Device Rules (MDR) 2017, enforced by CDSCO at the state level.

The licensing authority for Class A devices like eye pads is the respective State Licensing Authority, and the applicable manufacturing license is the MD5 license. This ensures compliance with quality, safety, and performance standards designed to protect patient health.

Risk Classification and License Requirements for Eye Pads

• Risk Class: A (Low risk)
• Applicable License: MD5 Manufacturing License (Form MD3)
• Regulatory Authority: State Licensing Authority
• Additional Requirements: Test License (Form MD13) prior to manufacturing license application

For detailed classification, you can refer to the official Medical Device Classification guide.

Manufacturing License Process for Eye Pads (MD5 License)

The MD5 license process for eye pads involves several critical steps:

1. Obtain Test License (Form MD13): Required before manufacturing the device to conduct necessary tests.
2. Product Testing: Conduct testing at CDSCO-approved government testing laboratories.
3. Document Preparation: Compile comprehensive technical and quality documentation.
4. Application Submission (Form MD3): Apply for MD5 license through the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body for plant and quality system audit. Refer to the list of notified bodies.
6. Resolve Queries: Address any queries from CDSCO or the notified body promptly.
7. License Grant: Upon successful audit and document verification, license is granted on Form MD5.

Manufacturing License Documents Required for Eye Pads

For the MD5 application, you must prepare and submit the following documents:

• Certified copy of the company’s constitution (e.g., incorporation certificate)
• Proof of ownership or tenancy of manufacturing premises
• Qualification and experience documents of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process (DMF Guide)
• Plant Master File (PMF) outlining manufacturing facilities (PMF Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance
• Risk Management File specific to eye pads (Risk Management)
• Test Reports from CDSCO-approved labs (Testing Laboratories)
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, including ISO 13485 certification if available

Import License Process for Eye Pads (MD15 License)

For importers of eye pads, the MD15 import license is mandatory and issued by the Central Licensing Authority. The process involves:

• Document preparation including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate
• Submission of application using Form MD14 on the CDSCO MD Online Portal
• Queries resolution
• Final license grant on Form MD15

Since eye pads are Class A devices, applicable government fees are lower compared to higher-risk classes.

Import License Documents Required for Eye Pads

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

For detailed guidance, refer to our Import License Guide.

Timeline and Processing Duration

• Test License (MD13): Approximately 1.5 to 2 months
• Product Testing: 3 to 4 weeks depending on lab workload
• MD5 License Application and Audit: 1.5 to 2 months

Total estimated duration for MD5 license: 3 to 4 months from application initiation to license grant.

Timelines can vary based on document readiness, audit scheduling, and query resolution.

Government Fees and Costs

• Test License (MD13): Nominal fees as per state authority
• MD5 License Application: Rs. 5,000 per application
• Product Fee: Rs. 500 per product (for eye pads, generally one product per license)
• Audit Fees: Paid directly to notified body; varies between Rs. 50,000 to Rs. 1,00,000 depending on scope

Budgeting for these fees upfront can prevent delays.

Common Challenges and Solutions

Challenge: Delays in test license approval and product testing.

Solution: Prepare all test samples and documentation meticulously; choose testing labs with shorter turnaround times from the CDSCO approved list.

Challenge: Incomplete documentation causing audit non-compliance.

Solution: Use our Plant Master File guide and Device Master File guide to ensure thorough documentation.

Challenge: Responding promptly and adequately to queries.

Solution: Maintain continuous communication with regulatory consultants and auditors to address actions quickly.

Expert Consultation and Support

Navigating the CDSCO licensing landscape requires expert knowledge and practical experience. We have supported over 500 manufacturers and importers by providing:

• Customized gap analysis for regulatory readiness
• Documentation drafting and review
• Coordination with notified bodies and testing labs
• End-to-end application filing on the CDSCO MD Online Portal

Our proven track record ensures you meet all regulatory requirements efficiently.

Getting Started with Your CDSCO License Application for Eye Pads

1. Assess Your Product Classification: Confirm eye pad classification as Class A.
2. Prepare Technical Documentation: Assemble Device Master File, Plant Master File, and Risk Management File.
3. Apply for Test License (Form MD13): Submit via CDSCO MD Online Portal to start product testing.
4. Schedule Product Testing: Choose a CDSCO-approved testing laboratory.
5. Engage a Notified Body: Schedule audit based on the notified bodies list.
6. Submit MD5 License Application (Form MD3): Upload all documents and audit reports.
7. Respond to Queries Promptly: Keep communication channels open with CDSCO and auditors.
8. Receive License and Commence Manufacturing: Upon approval, begin compliant manufacturing and marketing.

Embarking on this journey with expert guidance significantly reduces risks of rejection or delays. Contact us today to leverage our 25+ years of regulatory expertise and ensure your eye pads are compliant and market-ready in India.