CDSCO License for Contact lens protein-removal solution

Comprehensive Guide to CDSCO Licensing for Contact Lens Protein-Removal Solution (Class B Medical Device)

Navigating the regulatory landscape for medical devices in India can be complex, especially for ophthalmology products like contact lens protein-removal solutions. These formulations, designed to enzymatically remove protein deposits and debris from reusable contact lenses, fall under Risk Class B according to CDSCO classification. With over 25 years of experience helping 500+ companies secure CDSCO licenses, we provide a detailed, actionable roadmap to obtain your manufacturing or import license efficiently.

CDSCO Regulatory Framework for Contact Lens Protein-Removal Solutions

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. For ophthalmic devices such as protein-removal solutions, compliance with both classification and licensing mandates under the Medical Device Rules (MDR) 2017 is essential. The notified reference for this device is Fts No. 29/MiscJO3/2020-DC (187), notified on 9th August 2021, confirming its classification within Class B.

Risk Classification and License Requirements for Class B Devices

Contact lens protein-removal solutions are categorized as Class B — low to moderate risk devices. This classification means manufacturers must obtain a manufacturing license under Form MD5 (application via Form MD3) issued by the State Licensing Authority. Importers require an import license under Form MD15, issued centrally.

• Class B Manufacturing License: MD5
• Governing Authority: State Licensing Authority
• Approximate Timeline: 3–4 months
• Fees: ₹5,000 per application + ₹500 per product

For detailed classification guidelines, manufacturers can refer to this Medical Device Classification resource.

Manufacturing License Process (MD5) for Contact Lens Protein-Removal Solutions

The manufacturing license process involves several key steps:

1. Test License (Form MD13): Obtain a test license first, valid for 6 months, to produce samples for testing. This step typically takes 1.5 to 2 months.
2. Product Testing: Conduct mandatory product testing at CDSCO-recognized labs. Refer to the list of approved testing laboratories.
3. Documentation Preparation: Compile a comprehensive dossier including technical and quality documents.
4. Application Submission: Submit manufacturing license application on the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: Schedule and complete audit by a notified body listed here.
6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
7. License Grant: Upon successful audit and document review, license is granted on Form MD5.

Manufacturing License Documents Required

Successful application hinges on meticulous document preparation. The required documents for a Class B contact lens protein-removal solution manufacturing license include:

• Company Constitution and Incorporation Certificate
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• No Objection Certificates: Fire Safety, Pollution Control
• Device Master File (DMF): Specifications, formulation details, manufacturing process (Device Master File Guide)
• Plant Master File (PMF): Facility layout, equipment, quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian MDR
• Risk Management File addressing device-specific risks (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents including SOPs

Import License Process (MD15) for Contact Lens Protein-Removal Solutions

For importers, the process is centralized under CDSCO:

1. Document Preparation: Assemble documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and Indian-specific files.
2. Application Submission: Apply using Form MD14 via the CDSCO MD Online Portal.
3. Query Resolution: Promptly respond to CDSCO queries.
4. License Grant: MD15 license issuance enables import and sale.

Import License Documents Required

Key documents required for import license application include:

• Manufacturing License from the exporting country
• Free Sale Certificate
• ISO 13485:2016 and CE Certificates
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution

Timeline and Processing Duration

Early initiation of testing and document compilation can help avoid bottlenecks.

Government Fees and Costs

• Manufacturing License (Class B): ₹5,000 application fee + ₹500 per product
• Import License (Class B): Approx. $2,000 per site +$1,000 per product
• Additional costs include notified body audit fees, testing laboratory charges (varies by test scope), and consultant fees if external help is engaged.

Common Challenges and Practical Solutions

• Delayed Testing Approvals: To mitigate delays, pre-book slots at CDSCO-approved labs early. Consider labs with faster turnaround times from the Testing Laboratories list.
• Incomplete Documentation: Use checklists from our Device Master File and Plant Master File guides to ensure completeness.
• Audit Non-Compliance: Engage experienced notified bodies and conduct internal audits before the official audit to preempt issues.
• Query Resolution Delays: Assign a dedicated regulatory liaison to respond quickly to CDSCO queries.

Expert Consultation and Support

With 25+ years of assisting over 500 companies, we specialize in streamlining CDSCO licensing for ophthalmic and Class B devices like contact lens protein-removal solutions. Our services include:

• Comprehensive gap analysis
• End-to-end documentation support
• Scheduling and managing test licenses and audits
• Liaison with CDSCO officials and notified bodies

Feel free to consult with us to accelerate your licensing journey and avoid costly delays.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class B and applicable under the notified regulation.
2. Obtain Test License (MD13): Apply immediately via the CDSCO MD Online Portal to initiate sample production.
3. Schedule Product Testing: Contact CDSCO-approved laboratories early to book test slots.
4. Prepare Device & Plant Master Files: Use available expert guides to compile accurate files.
5. Engage a Notified Body: Choose from the list of notified bodies and schedule your audit.
6. Submit Manufacturing License Application: Apply on the CDSCO portal with all required documents.
7. Respond Promptly to Queries: Ensure a dedicated team handles all communications.

Starting early and following a well-structured plan is critical for timely CDSCO approval. Contact us today to discuss your specific requirements and initiate your licensing process with confidence.